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DuraSeal®Dural Sealant System
REF: 202010DS / 202050
CONTRAINDICATIONSDo not apply the DuraSeal hydrogel to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling.
The hydrogel may swell up to 50% of its size in any direction.
WARNINGS• The safety and effectiveness of the DuraSeal hydrogel has not been studied in:
• Patients with a known allergy to FD&C Blue #1 dye.
• Patients undergoing a contaminated cranial procedure that entails a dural incision involving penetration (other than superficial) of the air sinus or mastoid air cells.
• Patients with severely altered renal or hepatic function.
• Patients with a compromised immune system or autoimmune disease.
• Procedures involving petrous bone drilling.
• Patients with traumatic injuries to the head.
• Procedures involving non-autologous duraplasty materials that are not collagen based.
• Do not use if an active infection is present at the surgical site.
PRECAUTIONS• Use only with the delivery system provided with the polymer kit.
• The DuraSeal Dural Sealant System is provided sterile. Do not use if packaging or seal has been damaged or opened. Do not re-sterilize.
• The DuraSeal Dural Sealant System is intended for single patient use only. Discard opened and unused product.
• Do not use if the PEG powder is not free flowing.
• Use within 1 hour of preparation.
• Do not use in combination with other sealants or hemostatic agents.
• Do not use in patients younger than 13 years of age, or in pregnant or breast feeding females.
• Prior to application of the DuraSeal hydrogel, ensure that adequate hemostasis has been achieved.
• Incidental application of DuraSeal hydrogel to tissue planes that will be subsequently approximated, such as muscle and skin, should be avoided.
ADVERSE EVENTSThe DuraSeal Dural Sealant System was evaluated in 111 investigational patients in the pivotal clinical study. The following table presents any adverse event occurring at a rate of 1% or higher in these patients. Adverse event rates presented are based on the number of patients having at least one occurrence of a particular adverse event divided by the total number of patients treated.
The incidence and nature of adverse events observed in this patient population are consistent with the type and complexity of the surgery performed and the co-morbid state of the treated patients. There were two patient deaths (out-of-hospital). In both cases, the deaths were attributed to the patients’ prior condition.
AE categoryNote: Patient can experience more than one AE
# of patientsn (%)
Arrhythmia 6 (5.4)
Bleeding 4 (3.6)
Cerebral Edema 4 (3.6)
CSF Leak (protocol definition)
Incisional
Pseudomeningocele
2 (1.8)
3 (2.7)
Dermatologic Events 11 (9.1)
Dizziness 8 (7.2)
Edema (non-systemic) 19 (17.1)
Electrolyte Imbalance 11 (9.9)
Elevated Liver Enzymes 11 (9.9)
Fever Post-op (> 38.5°C for 48 h) 6 (5.4)
Fever (< 38.5°C for < 48 h) 5 (4.5)
General Malaise 9 (8.1)
General - Other: Corneal abrasion, chemotherapy complication, hiccoughs 3 (2.7)
GI Disturbance 16 (14.4)
Headache (not responding to standard therapy) 5 (4.5)
Headache (responding to standard therapy) 9 (8.1)
Hematologic Abnormality 7 (6.3)
Hydrocephalus 4 (3.6)
Hypertension 5 (4.5)
Infection, Non-Incisional
Thrush, otitis media, keratitis,
catheter-related
Upper Respiratory/Bronchial
Urinary Tract
8 (7.2)
4 (3.6)
11 (9.9)
Infection, Surgical Site
Deep (re-operation required)
Superficial
8 (7.2)
1 (0.9)
Late (> 30 days) Wound Infection 3 (2.7)
Meningitis
Aseptic
Bacterial
5 (4.5)
2 (1.8)
Musculoskeletal Events 21 (18.9)
Nausea and/or Vomiting 24 (21.6)
Neurological Symptoms
Cognitive
Cranial Nerve Deficit
Motor Deficit
Neuropsychiatric disorders
Speech Difficulty
Visual Disturbance
5 (4.5)
34 (30.0)
17 (15.3)
7 (6.3)
10 (9.0)
22 (19.8)
Pain, Incisional 2 (1.8)
Peripheral edema 2 (1.8)
Pneumonia 3 (2.7)
Pseudomeningocele (responding to conservative therapy) 2 (1.8)
Respiratory Difficulties 6 (5.4)
Seizure 3 (2.7)
Stroke/CVA/Cerebral Hemorrhage 5 (4.5)
Subdural Hematoma 2 (1.8)
Ureterolitithiasis 2 (1.8)
Urinary Difficulty 9 (8.1)
Urogenital - Other 2 (1.8)
Wound erythematic/inflammation 2 (1.8)
Potential, but not observed, risks and adverse events that could occur from the use of the DuraSeal Dural Sealant System include, but are not limited to, renal compromise, inflammatory reaction, neurological compromise, allergic reaction and/or delayed healing.
CLINICAL EXPERIENCEPre-Approval StudyA prospective, multi-center, non-randomized, single arm clinical investigation to evaluate the safety and effectiveness of the DuraSeal Dural Sealant System as an adjunct to sutured dural repair was conducted. The study involved 10 investigational sites within the United States and 1 site in Europe. A total of 111 patients were treated with the DuraSeal Sealant.
The primary endpoint for this study was the percent (%) success in the treatment of intraoperative CSF leakage following DuraSeal Sealant application defined as no CSF leakage from dural repair intra-operatively after up to two DuraSeal Sealant applications during Valsalva maneuver up to 20 cm H
2O for 5 to 10 seconds.
Key Inclusion/Exclusion criteria for the study included the following:
Pre-Operative Inclusion Criteria:• Patient is scheduled for an elective cranial procedure that entails a dural incision using any of the following approaches (or combination): Frontal, Temporal, Parietal, Occipital, and/or Suboccipital.
• Patient requires a procedure involving surgical wound classification Class I/Clean.
Pre-Operative Exclusion Criteria:• Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/or any procedure
that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded.
• Patient has had a prior intracranial procedure in the same anatomical location.
• Patient has had chemotherapy treatment within 6 months prior to, or planned during the study (until completion of last follow-up evaluation).
• Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within one month post procedure.
• Patient has hydrocephalus (e.g. elevated intracranial pressure > 22 cm H2O).
• Patient has a known malignancy or another condition with prognosis shorter than 6 months (patients with stable systemic disease can be included, extent of disease will be documented).
• Patient has pre-existing external ventricular drainage or lumbar CSF drain.
• Patient is not able to tolerate multiple Valsalva maneuvers or an intra-operative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers.
• Patient has a systemic infection (UTI, active pneumonia) or evidence of any surgical site infection (superficial, deep, or organ/space), as determined by fever > 101°F, WBC > 11,000/uL, positive blood culture, positive urine culture, and/or by a positive chest x-ray.
• Patient has been treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted).
• Patient has a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL).
• Patient with uncontrolled diabetes, as determined by two or more incidences of elevated blood sugar levels (fasting glucose >120mg/dL) within the 6 months prior to surgery.
• Patient with creatinine levels > 2.0 mg/dL.
Intra-Operative Inclusion Criteria:• Surgical wound classification Class I/Clean (per CDC criteria).
• Linear extent of durotomy is at least 2 cm.
• Dural margin from edges of bony defect is at least 3 mm throughout.
• Patient must have a CSF leak after primary dural closure, either spontaneous or upon Valsalva maneuver, up to 20 cm H
2O for 5-10 seconds.
Intra-Operative Exclusion Criteria:• Patient required use of synthetic or non-autologous duraplasty material.
• Patient has a gap greater than 2 mm remaining after primary dural closure.
• Incidental finding of any of the Pre-operative Exclusion Criteria.
Of the 111 patients in this study, 67 patients (60.4%) experienced a spontaneous CSF leak intra-operatively (i.e., no need for Valsalva maneuver) prior to DuraSeal application, and 44 patients (39.6%) experienced a leak upon the Valsalva maneuver prior to DuraSeal application. One hundred five (105) patients (94.6%) were treated with one DuraSeal Sealant application, and 6 patients (5.4%) were treated with two applications.
Demographic information for patients treated in the study is shown in the table below:
Characteristic Study Population n (%)Duration of Surgery:
< 2 hours
≥ 2 hours
Unknown
7 (6.3)
102 (91.8)
2 (1.8)
ASA Score:
1
2
≥ 3
14 (12.6)
59 (53.2)
37 (33.3)
Indication for Surgery:
AVM
Aneurysm
Chiari Malformation
Cyst
Epilepsy
Nerve Decompression
Tumor
Other
7 (6.3)
12 (10.8)
6 (5.4)
3 (2.7)
10 (9.0)
21 (18.9)
51 (45.9)
1 (0.9)
All 111 patients treated with the DuraSeal Sealant showed no leakage during the intra-operative assessment. 109 of 111 patients (98.2%) met the criteria for primary endpoint success; i.e., intraoperative sealing. Two patients were tested intra-operatively at a pressure of only 10 cm H2
O, and although no leak was seen, these patients could not technically be classified as successes. Safety was assessed based on evaluation of wound healing, the occurrence of post-operative CSF leaks, the nature and severity of other adverse events, and device-related adverse events diagnosed by physical examination, protocol-specified diagnostic laboratory tests, neurological assessments (including pain and modified Rankin Scale) and CT imaging assessment performed by independent radiologists for evaluation of extradural collections and adverse findings.
The incidence of post-op CSF leaks in this study was 4.5%. Of these leaks, 1.8% were incisional and 2.7% were pseudomeningoceles. There were 9/111 surgical wound infections (8.1%) with 7.2% identified as deep wound infections. All deep wound infections were treated with surgical debridement. There was no concurrent control group used for comparison in the study. The clinical protocol specified only clean surgical cases and contained an intra-operative exclusion criterion for cases in which a clean case became a clean-contaminated case (e.g., sinus penetration. History of smoking and prolonged surgery were found to be independent predictors for infection).
All wounds were well healed by the 3-month post-operative visit. There was no untoward effect on hepatic or renal function associated with product use and absorption. Additionally, there were no unexpected findings based on CT imaging assessment by independent neuroradiologists.
Due to a high water content, DuraSeal appears similar to simple fluids on CT and MRI imaging following initial instillation. Thus, DuraSeal is dark on CT and T1-weighted MRI images (similar to cerebrospinal fluid). T2-weighted MRI is helpful in differentiating DuraSeal from cerebrospinal fluid. While being absorbed, vascular enhancement of the residual margins is normally seen, and the space occupied by the hydrogel collapses. Based on CT imaging of 111 patients in the study, the average reduction in extradural space at the DuraSeal application site was 74.5% at 3 months.
The hydrogel potentially may have overlapping imaging characteristics with either persistent unilocular fluid collection or with an infected surgical bed. In the event that CT or MR imaging is unable to confidently exclude infection, then an indium labeled white-blood cell nuclear medicine study may be warranted.
Post-Approval Study:A prospective, randomized, single blind (patients), multi-center, post-market study was conducted with DuraSeal Sealant as compared to other commonly practiced methods of dural closure in patients scheduled for cranial surgery that entailed a dural incision. The purpose of the study was to estimate the incidence of surgical wound complications such as infections, central nervous system events, or neurosurgical complications such as CSF leaks that resulted in unplanned intervention (i.e., minimally invasive procedures) or a return to the operating room. This study was required by the FDA as a condition of approval to evaluate the incidence of wound-related complications, including infection and CSF leaks associated with use of DuraSeal Dural Sealant.
1a 1b
1c 1d
1e
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BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.IMPORTANT!This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTIONThe DuraSeal® Dural Sealant System consists of components for preparation of a synthetic absorbable sealant, and an applicator for delivery of the sealant to the target site.
The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution (referred to as the ‘blue’ and ‘clear’ precursors, respectively). When mixed together, the precursors cross link to form the hydrogel sealant. The mixing of the precursors is accomplished as the materials exit the tip of the applicator.
The hydrogel implant is absorbed in approximately 4 to 8 weeks, sufficient time to allow for healing.
INDICATIONThe DuraSeal Dural Sealant System is intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
Box Size: 4.38 x 13.19
Overall Size: 8.5 x 11
Folds to: 2.75 x 4.25
DuraSeal®Dural Sealant System
REF: 202010DS / 202050
CONTRAINDICATIONSDo not apply the DuraSeal hydrogel to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling.
The hydrogel may swell up to 50% of its size in any direction.
WARNINGS• The safety and effectiveness of the DuraSeal hydrogel has not been studied in:
• Patients with a known allergy to FD&C Blue #1 dye.
• Patients undergoing a contaminated cranial procedure that entails a dural incision involving penetration (other than superficial) of the air sinus or mastoid air cells.
• Patients with severely altered renal or hepatic function.
• Patients with a compromised immune system or autoimmune disease.
• Procedures involving petrous bone drilling.
• Patients with traumatic injuries to the head.
• Procedures involving non-autologous duraplasty materials that are not collagen based.
• Do not use if an active infection is present at the surgical site.
PRECAUTIONS• Use only with the delivery system provided with the polymer kit.
• The DuraSeal Dural Sealant System is provided sterile. Do not use if packaging or seal has been damaged or opened. Do not re-sterilize.
• The DuraSeal Dural Sealant System is intended for single patient use only. Discard opened and unused product.
• Do not use if the PEG powder is not free flowing.
• Use within 1 hour of preparation.
• Do not use in combination with other sealants or hemostatic agents.
• Do not use in patients younger than 13 years of age, or in pregnant or breast feeding females.
• Prior to application of the DuraSeal hydrogel, ensure that adequate hemostasis has been achieved.
• Incidental application of DuraSeal hydrogel to tissue planes that will be subsequently approximated, such as muscle and skin, should be avoided.
ADVERSE EVENTSThe DuraSeal Dural Sealant System was evaluated in 111 investigational patients in the pivotal clinical study. The following table presents any adverse event occurring at a rate of 1% or higher in these patients. Adverse event rates presented are based on the number of patients having at least one occurrence of a particular adverse event divided by the total number of patients treated.
The incidence and nature of adverse events observed in this patient population are consistent with the type and complexity of the surgery performed and the co-morbid state of the treated patients. There were two patient deaths (out-of-hospital). In both cases, the deaths were attributed to the patients’ prior condition.
AE categoryNote: Patient can experience more than one AE
# of patientsn (%)
Arrhythmia 6 (5.4)
Bleeding 4 (3.6)
Cerebral Edema 4 (3.6)
CSF Leak (protocol definition)
Incisional
Pseudomeningocele
2 (1.8)
3 (2.7)
Dermatologic Events 11 (9.1)
Dizziness 8 (7.2)
Edema (non-systemic) 19 (17.1)
Electrolyte Imbalance 11 (9.9)
Elevated Liver Enzymes 11 (9.9)
Fever Post-op (> 38.5°C for 48 h) 6 (5.4)
Fever (< 38.5°C for < 48 h) 5 (4.5)
General Malaise 9 (8.1)
General - Other: Corneal abrasion, chemotherapy complication, hiccoughs 3 (2.7)
GI Disturbance 16 (14.4)
Headache (not responding to standard therapy) 5 (4.5)
Headache (responding to standard therapy) 9 (8.1)
Hematologic Abnormality 7 (6.3)
Hydrocephalus 4 (3.6)
Hypertension 5 (4.5)
Infection, Non-Incisional
Thrush, otitis media, keratitis,
catheter-related
Upper Respiratory/Bronchial
Urinary Tract
8 (7.2)
4 (3.6)
11 (9.9)
Infection, Surgical Site
Deep (re-operation required)
Superficial
8 (7.2)
1 (0.9)
Late (> 30 days) Wound Infection 3 (2.7)
Meningitis
Aseptic
Bacterial
5 (4.5)
2 (1.8)
Musculoskeletal Events 21 (18.9)
Nausea and/or Vomiting 24 (21.6)
Neurological Symptoms
Cognitive
Cranial Nerve Deficit
Motor Deficit
Neuropsychiatric disorders
Speech Difficulty
Visual Disturbance
5 (4.5)
34 (30.0)
17 (15.3)
7 (6.3)
10 (9.0)
22 (19.8)
Pain, Incisional 2 (1.8)
Peripheral edema 2 (1.8)
Pneumonia 3 (2.7)
Pseudomeningocele (responding to conservative therapy) 2 (1.8)
Respiratory Difficulties 6 (5.4)
Seizure 3 (2.7)
Stroke/CVA/Cerebral Hemorrhage 5 (4.5)
Subdural Hematoma 2 (1.8)
Ureterolitithiasis 2 (1.8)
Urinary Difficulty 9 (8.1)
Urogenital - Other 2 (1.8)
Wound erythematic/inflammation 2 (1.8)
Potential, but not observed, risks and adverse events that could occur from the use of the DuraSeal Dural Sealant System include, but are not limited to, renal compromise, inflammatory reaction, neurological compromise, allergic reaction and/or delayed healing.
CLINICAL EXPERIENCEPre-Approval StudyA prospective, multi-center, non-randomized, single arm clinical investigation to evaluate the safety and effectiveness of the DuraSeal Dural Sealant System as an adjunct to sutured dural repair was conducted. The study involved 10 investigational sites within the United States and 1 site in Europe. A total of 111 patients were treated with the DuraSeal Sealant.
The primary endpoint for this study was the percent (%) success in the treatment of intraoperative CSF leakage following DuraSeal Sealant application defined as no CSF leakage from dural repair intra-operatively after up to two DuraSeal Sealant applications during Valsalva maneuver up to 20 cm H
2O for 5 to 10 seconds.
Key Inclusion/Exclusion criteria for the study included the following:
Pre-Operative Inclusion Criteria:• Patient is scheduled for an elective cranial procedure that entails a dural incision using any of the following approaches (or combination): Frontal, Temporal, Parietal, Occipital, and/or Suboccipital.
• Patient requires a procedure involving surgical wound classification Class I/Clean.
Pre-Operative Exclusion Criteria:• Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/or any procedure
that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded.
• Patient has had a prior intracranial procedure in the same anatomical location.
• Patient has had chemotherapy treatment within 6 months prior to, or planned during the study (until completion of last follow-up evaluation).
• Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within one month post procedure.
• Patient has hydrocephalus (e.g. elevated intracranial pressure > 22 cm H2O).
• Patient has a known malignancy or another condition with prognosis shorter than 6 months (patients with stable systemic disease can be included, extent of disease will be documented).
• Patient has pre-existing external ventricular drainage or lumbar CSF drain.
• Patient is not able to tolerate multiple Valsalva maneuvers or an intra-operative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers.
• Patient has a systemic infection (UTI, active pneumonia) or evidence of any surgical site infection (superficial, deep, or organ/space), as determined by fever > 101°F, WBC > 11,000/uL, positive blood culture, positive urine culture, and/or by a positive chest x-ray.
• Patient has been treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard acute perioperative steroids are permitted).
• Patient has a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL).
• Patient with uncontrolled diabetes, as determined by two or more incidences of elevated blood sugar levels (fasting glucose >120mg/dL) within the 6 months prior to surgery.
• Patient with creatinine levels > 2.0 mg/dL.
Intra-Operative Inclusion Criteria:• Surgical wound classification Class I/Clean (per CDC criteria).
• Linear extent of durotomy is at least 2 cm.
• Dural margin from edges of bony defect is at least 3 mm throughout.
• Patient must have a CSF leak after primary dural closure, either spontaneous or upon Valsalva maneuver, up to 20 cm H
2O for 5-10 seconds.
Intra-Operative Exclusion Criteria:• Patient required use of synthetic or non-autologous duraplasty material.
• Patient has a gap greater than 2 mm remaining after primary dural closure.
• Incidental finding of any of the Pre-operative Exclusion Criteria.
Of the 111 patients in this study, 67 patients (60.4%) experienced a spontaneous CSF leak intra-operatively (i.e., no need for Valsalva maneuver) prior to DuraSeal application, and 44 patients (39.6%) experienced a leak upon the Valsalva maneuver prior to DuraSeal application. One hundred five (105) patients (94.6%) were treated with one DuraSeal Sealant application, and 6 patients (5.4%) were treated with two applications.
Demographic information for patients treated in the study is shown in the table below:
Characteristic Study Population n (%)Duration of Surgery:
< 2 hours
≥ 2 hours
Unknown
7 (6.3)
102 (91.8)
2 (1.8)
ASA Score:
1
2
≥ 3
14 (12.6)
59 (53.2)
37 (33.3)
Indication for Surgery:
AVM
Aneurysm
Chiari Malformation
Cyst
Epilepsy
Nerve Decompression
Tumor
Other
7 (6.3)
12 (10.8)
6 (5.4)
3 (2.7)
10 (9.0)
21 (18.9)
51 (45.9)
1 (0.9)
All 111 patients treated with the DuraSeal Sealant showed no leakage during the intra-operative assessment. 109 of 111 patients (98.2%) met the criteria for primary endpoint success; i.e., intraoperative sealing. Two patients were tested intra-operatively at a pressure of only 10 cm H2
O, and although no leak was seen, these patients could not technically be classified as successes. Safety was assessed based on evaluation of wound healing, the occurrence of post-operative CSF leaks, the nature and severity of other adverse events, and device-related adverse events diagnosed by physical examination, protocol-specified diagnostic laboratory tests, neurological assessments (including pain and modified Rankin Scale) and CT imaging assessment performed by independent radiologists for evaluation of extradural collections and adverse findings.
The incidence of post-op CSF leaks in this study was 4.5%. Of these leaks, 1.8% were incisional and 2.7% were pseudomeningoceles. There were 9/111 surgical wound infections (8.1%) with 7.2% identified as deep wound infections. All deep wound infections were treated with surgical debridement. There was no concurrent control group used for comparison in the study. The clinical protocol specified only clean surgical cases and contained an intra-operative exclusion criterion for cases in which a clean case became a clean-contaminated case (e.g., sinus penetration. History of smoking and prolonged surgery were found to be independent predictors for infection).
All wounds were well healed by the 3-month post-operative visit. There was no untoward effect on hepatic or renal function associated with product use and absorption. Additionally, there were no unexpected findings based on CT imaging assessment by independent neuroradiologists.
Due to a high water content, DuraSeal appears similar to simple fluids on CT and MRI imaging following initial instillation. Thus, DuraSeal is dark on CT and T1-weighted MRI images (similar to cerebrospinal fluid). T2-weighted MRI is helpful in differentiating DuraSeal from cerebrospinal fluid. While being absorbed, vascular enhancement of the residual margins is normally seen, and the space occupied by the hydrogel collapses. Based on CT imaging of 111 patients in the study, the average reduction in extradural space at the DuraSeal application site was 74.5% at 3 months.
The hydrogel potentially may have overlapping imaging characteristics with either persistent unilocular fluid collection or with an infected surgical bed. In the event that CT or MR imaging is unable to confidently exclude infection, then an indium labeled white-blood cell nuclear medicine study may be warranted.
Post-Approval Study:A prospective, randomized, single blind (patients), multi-center, post-market study was conducted with DuraSeal Sealant as compared to other commonly practiced methods of dural closure in patients scheduled for cranial surgery that entailed a dural incision. The purpose of the study was to estimate the incidence of surgical wound complications such as infections, central nervous system events, or neurosurgical complications such as CSF leaks that resulted in unplanned intervention (i.e., minimally invasive procedures) or a return to the operating room. This study was required by the FDA as a condition of approval to evaluate the incidence of wound-related complications, including infection and CSF leaks associated with use of DuraSeal Dural Sealant.
1a 1b
1c 1d
1e
1 2
54
9
3
C
1g1f
6 7 8
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.IMPORTANT!This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTIONThe DuraSeal® Dural Sealant System consists of components for preparation of a synthetic absorbable sealant, and an applicator for delivery of the sealant to the target site.
The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution (referred to as the ‘blue’ and ‘clear’ precursors, respectively). When mixed together, the precursors cross link to form the hydrogel sealant. The mixing of the precursors is accomplished as the materials exit the tip of the applicator.
The hydrogel implant is absorbed in approximately 4 to 8 weeks, sufficient time to allow for healing.
INDICATIONThe DuraSeal Dural Sealant System is intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
Box Size: 4.38 x 13.19
Overall Size: 8.5 x 11
Folds to: 2.75 x 4.25
Symbol Definition
Do not re-use
Upper limit of temperature
Sterilized using irradiation
Use by (YYYY-MM-DD)
Not made with natural rubber latex
Catalog number
Lot number
Consult Instructions for Use
Do not use if package is opened or damaged.
Manufacturer
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or practitioner
Do not re-sterilize
Date of manufacture (YYYY-MM-DD)
Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA.
1-800-654-2873/ Outside the USA: 609-275-0500
www.integralife.com
CAR0000442 Rev. 1 1002348-1
U.S. Patents 6,566,406; 6,887,974
DuraSeal, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
©2018 Integra LifeSciences Corporation. All Rights Reserved.
The methods of primary closure varied based on surgeon preference, however only autologous duraplasty materials were permitted. Following primary closure and upon identification of a CSF leak, subjects were randomized to either a standard of care arm or DuraSeal Sealant arm in a 1:1 ratio. A total of 237 subjects were enrolled, with 117 subjects being treated with standard of care (Control) and 120 treated with DuraSeal. Control methods frequently involved more than one type of material to seal the dura, including: adhesive glue, soft tissue patches, extra sutures, and absorbable gelatin sponges.
Demographic information for patients treated in the study is shown in the table below:
CharacteristicDuraSeal (N=120) n (%)
Control (N=117) n (%)
Duration of Surgery:
Mean (SD)
Median
Range (Min, Max)
3.19 (1.82)
2.83
0.9 , 11.3
3.23 (1.68)
2.72
1.1 , 10.3ASA Score:
1
2
3
4
5 (4.2)
61 ( 50.8)
50 ( 41.7)
4 ( 3.3)
4 (3.4)
59 ( 50.4)
53 ( 45.3)
1 (0.9)Indication for Surgery:
Tumor
AVM
Aneurysm
Chiari Malformation
Cyst
Epilepsy
Nerve Decompression
Other
59 ( 49.2)
6 ( 5.0)
14 ( 11.7)
0 ( 0.0)
2 ( 1.7)
13 ( 10.8)
22 ( 18.3)
4 ( 3.3)
55 ( 47.0)
0 ( 0.0)
18 ( 15.4)
1 ( 0.9)
6 ( 5.1)
14 ( 12.0)
20 ( 17.1)
3 ( 2.6)
Procedure characteristics were similar between groups with the exception of location. Infratentorial procedures were less frequent among the DuraSeal subjects than among the Control subjects, with rates of 30.0% and 42.7%, respectively. This difference was statistically significant with a p-value of 0.044. As infratentorial procedures can represent a higher risk for CSF leaks, a Cochran-Mantel-Haenszel analysis was conducted, stratifying by surgical location. In the analysis, there was no statistical evidence of a difference between the treatments in the primary endpoint after taking surgical location into account (p=0.528).
The primary endpoint of the study is the incidence of surgical wound complications, central nervous system events, or neurosurgical complications that resulted in unplanned intervention (i.e., minimally invasive procedures) or a return to the operating room. In all of these categories there was no significant difference between DuraSeal sealant and Control. The overall percentage of subjects experiencing a primary endpoint complication was 5.8% DuraSeal and 7.7% Control group, p=0.613. The rate of events for each category in the primary endpoint- surgical wound complications, central nervous system events, and neurosurgical complications resulting in unplanned intervention or a return to the operating room- resulted in no significant difference between the two groups. There were also no significant differences between the two groups for any of the subcategories of primary endpoint events.
The secondary endpoint of the study is the incidence of post-operative surgical site infection or post-operative CSF leaks within 30 days post-operative, as well as Neurological Status Assessments. The overall infection rate (including superficial, deep and organ/space infections) was comparable between groups (1.7 % DuraSeal, 2.6% Control, p= 0.681).
There were three CSF leaks reported during the course of this study, including one in the DuraSeal group and two in the Control group (0.8% DuraSeal vs 1.7% Control, p=0.619). The reported leak rate did not show a significant difference between groups.
For each of the neurological areas assessed- neurological status, cranial nerve, and motor, reflex, sensory and gait exams, no statistically significant differences were found between groups. For the Neurological assessment specifically, most subjects were found to have normal results at each follow-up time point. McNemar’s Test was used to assess for a difference in the probability of falling into the ‘normal’, ‘present’ or ‘affected’ category between the baseline visit and each post-baseline visit. The neurological assessment included evaluation of vital sign instability, level of consciousness, personality changes, speech disorder and visual changes, rating responses as normal, slightly abnormal, moderately abnormal, severely abnormal, or unable to measure or missing. The majority of subjects were assessed as “Normal” for each of these components at the baseline and subsequent visits. There were no significant changes within either group from the baseline assessment to either post-baseline assessment for any component of the neurological assessment.
ADVERSE EVENTSThe DuraSeal Dural Sealant System was evaluated in 120 investigational patients in the post-approval clinical study while 117 patients were treated with other commonly used techniques of dural closure. The following table presents any adverse event occurring at a rate of 1% or higher in these patients. Adverse Event rates presented are based on the number of patients having at least one occurrence of a particular adverse event divided by the total number of patients treated.
The incidence and nature of adverse events observed in this patient population are consistent with the type and complexity of the surgery performed and the co-morbid state of the treated patients.
AE categoryNote: Patient can experience more
than one AE
DuraSeal (N=120)
n(%)
Control (N=117)
n(%)p-value
Any Complication 20 ( 16.7) 22 ( 18.8) 0.735Superficial Incisional SSI 0 ( 0.0) 3 ( 2.6) 0.119
Deep Incisional SSI 2 ( 1.7) 0 ( 0.0) 0.498Organ/Space SSI 0 ( 0.0) 0 ( 0.0) -----
Late Incisional SSI 3 ( 2.5) 1 ( 0.9) 0.622Poor Wound Healing 0 ( 0.0) 1 ( 0.9) 0.494
CSF Leak 1 ( 0.8) 2 ( 1.7) 0.619Hydrocephalus 1 ( 0.8) 1 ( 0.9) 1.000
Meningitis (Bacterial) 0 ( 0.0) 0 ( 0.0) -----Meningitis (Aseptic) 0 ( 0.0) 1 ( 0.9) 0.494Pseudomeningocele 1 ( 0.8) 1 ( 0.9) 1.000Cerebral Hemorrhage 3 ( 2.5) 1 ( 0.9) 0.622
Cerebral Edema 2 ( 1.7) 0 ( 0.0) 0.498Cerebral Vascular Accident (stroke) 1 ( 0.8) 2 ( 1.7) 0.619
Other 13 ( 10.8) 14 ( 12.0) 0.840 Note: p-value is based on Fisher’s Exact test.
There were two reports of Deep Surgical Site Infections in the DuraSeal group and three reports of Superficial Infections in the Control group. The difference was not statistically significant between groups and in both cases of Deep Surgical Site Infections, the treating investigators identified the complications as being related to the procedure as a result of an infected bone flap that was subsequently removed.
Evidence of DuraSeal use with non-autologous collagen duraplasty materials:In a separate evaluation, preclinical and clinical testing of DuraSeal use with non-autologous duraplasty materials has been completed. A study was performed in a canine craniotomy model to evaluate the performance of DuraSeal when used in conjunction with commercially available collagen duraplasty onlay products to augment dural closures. The results of this study demonstrated a 100% improvement in intraoperative sealing success and an 83.3% reduction in postoperative CSF leaks in animals treated with DuraSeal in conjunction with collagen duraplasty compared to animals treated with collagen duraplasty alone. At reoperation, decreased dura mater-bone flap adhesion formation was documented in animals that had DuraSeal application to the duraplasty onlay. Histologically, the application of DuraSeal over the collagen duraplasty was not associated with neurotoxicity, delayed healing, degenerative changes, increased dura-brain adhesions, or impaired neodura formation.
A retrospective, multi-center, non randomized study was conducted to evaluate the safety of DuraSeal Sealant as an adjunct to sutured dural repair to provide watertight closure when used in conjunction with non-autologous duraplasty materials. The evaluation involved 3 sites within the United States. A total of 66 patients were identified who were treated with DuraSeal Sealant in conjunction with primarily collagen-based duraplasty (Retrospective Population).
The safety assessment was based upon the incidence rate of neurosurgical complications, (i.e., post-operative CSF leak, surgical site infection and meningitis) observed in the Retrospective Population, as compared to the incidence rate of these same complications observed in a subset of the patient population enrolled in the 111 patient study who were treated with DuraSeal Sealant in conjunction with autologous duraplasty (PMA Population; 50 patients).
The Retrospective and PMA Populations were similar with respect to patient baseline characteristics with the following notable exceptions; the Retrospective Population included substantially more patients with an ASA score of 3 or more, included a small subset of Clean-contaminated procedures (5%); whereas, the procedures performed within the PMA Population were all Clean procedures; and, a larger proportion of patients within the Retrospective Population underwent tumor resections as compared with the PMA Population. The mean durotomy length was slightly longer for the Retrospective Population than for the PMA Population. The number of supratentorial and infratentorial procedures varied between the Retrospective and PMA Populations with supratentorial procedures representing 59.1% and infratentorial procedures representing 37.9% of the Retrospective Population, while the PMA Population was 36% supratentorial procedures and 62% infratentorial procedures.
The Retrospective and PMA Populations each had a similar incidence of combination supratentorial and infratentorial procedures (3% and 2% respectively).
The post-operative CSF leak rate was 7.4% and 6.0% for the Retrospective and PMA Populations respectively. Only one late surgical site infection was noted within the Retrospective Population with an associated incidence rate of 1.5% compared with an overall infection rate of 6.0% for the PMA Population. There were no serious device-related adverse events or unanticipated adverse device effects noted for either population.
1 HOW SUPPLIEDThe components of the DuraSeal System are:
1a) DILUENT SYRINGE (BLUE LABEL) WITH BLUE CAP (1)
1b) POWDER VIAL (1)
1c) CLEAR PRECURSOR SYRINGE WITH WHITE CAP (1)
1d) PLUNGER CAP (1)
1e) SYRINGE HOLDER (1)
1f) APPLICATOR (1)
1g) SPRAY TIP (3)
DIRECTIONS FOR USEThe application procedure consists of three steps:A) Preparing the Blue Precursor,
B) Assembling the DuraSeal System Applicator; and
C) Hydrogel Application
Preparing the Blue PrecursorNOTE: Inspect the PEG powder vial to ensure the powder is free flowing, or can be loosened up by shaking. If the powder remains not free-flowing, discard the entire kit.
1. Open the pouch and introduce the polymer kit tray into the sterile field.
2. Once in the sterile field, remove the lid from the polymer kit tray.
3. Remove and discard syringe cap from diluent syringe (blue label).
4. Depress the threaded fitting of the vial cap (Figure 1).
5. Ensure red line is no longer visible (Figure 2).
6. Screw the diluent syringe to the powder vial and inject content into vial (Figure 3).
7. Gently shake the vial/syringe assembly until the powder is completely dissolved. The solution will turn blue (Figure 4).
8. Invert the vial/syringe assembly, and draw the vial contents back into the syringe (Figure 5).
9. Unscrew the syringe from the vial and discard the vial.
Assembling the DuraSeal System Applicator1. Remove syringe cap from clear precursor syringe.
2. Prior to attaching the syringes to the applicator, ensure syringe fluid levels are equal. If fluid levels are not equal, expel fluids out of syringes until equal.
3. Attach blue and clear precursor syringes to the applicator (Figure 6).
4. Attach the syringe holder which slides over both syringe barrels. Carefully attach the plunger cap to the plungers of both syringes without dispensing precursors into the applicator. Hold the syringes by the plungers while performing this operation so as to not deliver any of the precursors into the applicator (Figure 7).
5. Attach a spray tip to the applicator (Figure 8).
NOTE: Avoid touching the plunger cap before application to avoid inadvertent precursor injection and tip plugging.
Hydrogel ApplicationNOTE: Achieve hemostasis and minimize CSF outflow. Ensure that there are 2-3 mm margins around the durotomy edge and that the margins are clear of clots and fluids, hemostatic agents and loose connective tissue.
1. Position the applicator 2-4 cm from the target site. Apply firm even pressure to the center of the plunger cap to dispense the precursors. Rapid initial spraying, followed by a slower controlled rate is recommended. (Figure 9)
NOTE: While in the surgical field, whenever anatomically possible, briefly spray on gauze and without interrupting flow, move to the target site.
2. Continue applying the hydrogel until a thin (1 – 2 mm) coating is formed.
NOTE: If delivery is interrupted and the spray tip is plugged, remove the spray tip, wipe the applicator tip, attach a new spray tip and continue delivery.
NOTE: The blue color of the hydrogel aids in gauging thickness. As the thickness of the DuraSeal hydrogel increases to 2 mm, the fine epidural vasculature becomes less visible.
NOTE: Hydrogel application beyond the edges of the dural margin may be removed with scissors or mechanical disruption. Irrigation immediately after the sealant has solidified is permitted.
STORAGEThe DuraSeal Dural Sealant System should be stored at or below 77 °F (25°C).
Symbol Definition
Do not re-use
Upper limit of temperature
Sterilized using irradiation
Use by (YYYY-MM-DD)
Not made with natural rubber latex
Catalog number
Lot number
Consult Instructions for Use
Do not use if package is opened or damaged.
Manufacturer
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or practitioner
Do not re-sterilize
Date of manufacture (YYYY-MM-DD)
Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA.
1-800-654-2873/ Outside the USA: 609-275-0500
www.integralife.com
CAR0000442 Rev. 1 1002348-1
U.S. Patents 6,566,406; 6,887,974
DuraSeal, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
©2018 Integra LifeSciences Corporation. All Rights Reserved.
The methods of primary closure varied based on surgeon preference, however only autologous duraplasty materials were permitted. Following primary closure and upon identification of a CSF leak, subjects were randomized to either a standard of care arm or DuraSeal Sealant arm in a 1:1 ratio. A total of 237 subjects were enrolled, with 117 subjects being treated with standard of care (Control) and 120 treated with DuraSeal. Control methods frequently involved more than one type of material to seal the dura, including: adhesive glue, soft tissue patches, extra sutures, and absorbable gelatin sponges.
Demographic information for patients treated in the study is shown in the table below:
CharacteristicDuraSeal (N=120) n (%)
Control (N=117) n (%)
Duration of Surgery:
Mean (SD)
Median
Range (Min, Max)
3.19 (1.82)
2.83
0.9 , 11.3
3.23 (1.68)
2.72
1.1 , 10.3ASA Score:
1
2
3
4
5 (4.2)
61 ( 50.8)
50 ( 41.7)
4 ( 3.3)
4 (3.4)
59 ( 50.4)
53 ( 45.3)
1 (0.9)Indication for Surgery:
Tumor
AVM
Aneurysm
Chiari Malformation
Cyst
Epilepsy
Nerve Decompression
Other
59 ( 49.2)
6 ( 5.0)
14 ( 11.7)
0 ( 0.0)
2 ( 1.7)
13 ( 10.8)
22 ( 18.3)
4 ( 3.3)
55 ( 47.0)
0 ( 0.0)
18 ( 15.4)
1 ( 0.9)
6 ( 5.1)
14 ( 12.0)
20 ( 17.1)
3 ( 2.6)
Procedure characteristics were similar between groups with the exception of location. Infratentorial procedures were less frequent among the DuraSeal subjects than among the Control subjects, with rates of 30.0% and 42.7%, respectively. This difference was statistically significant with a p-value of 0.044. As infratentorial procedures can represent a higher risk for CSF leaks, a Cochran-Mantel-Haenszel analysis was conducted, stratifying by surgical location. In the analysis, there was no statistical evidence of a difference between the treatments in the primary endpoint after taking surgical location into account (p=0.528).
The primary endpoint of the study is the incidence of surgical wound complications, central nervous system events, or neurosurgical complications that resulted in unplanned intervention (i.e., minimally invasive procedures) or a return to the operating room. In all of these categories there was no significant difference between DuraSeal sealant and Control. The overall percentage of subjects experiencing a primary endpoint complication was 5.8% DuraSeal and 7.7% Control group, p=0.613. The rate of events for each category in the primary endpoint- surgical wound complications, central nervous system events, and neurosurgical complications resulting in unplanned intervention or a return to the operating room- resulted in no significant difference between the two groups. There were also no significant differences between the two groups for any of the subcategories of primary endpoint events.
The secondary endpoint of the study is the incidence of post-operative surgical site infection or post-operative CSF leaks within 30 days post-operative, as well as Neurological Status Assessments. The overall infection rate (including superficial, deep and organ/space infections) was comparable between groups (1.7 % DuraSeal, 2.6% Control, p= 0.681).
There were three CSF leaks reported during the course of this study, including one in the DuraSeal group and two in the Control group (0.8% DuraSeal vs 1.7% Control, p=0.619). The reported leak rate did not show a significant difference between groups.
For each of the neurological areas assessed- neurological status, cranial nerve, and motor, reflex, sensory and gait exams, no statistically significant differences were found between groups. For the Neurological assessment specifically, most subjects were found to have normal results at each follow-up time point. McNemar’s Test was used to assess for a difference in the probability of falling into the ‘normal’, ‘present’ or ‘affected’ category between the baseline visit and each post-baseline visit. The neurological assessment included evaluation of vital sign instability, level of consciousness, personality changes, speech disorder and visual changes, rating responses as normal, slightly abnormal, moderately abnormal, severely abnormal, or unable to measure or missing. The majority of subjects were assessed as “Normal” for each of these components at the baseline and subsequent visits. There were no significant changes within either group from the baseline assessment to either post-baseline assessment for any component of the neurological assessment.
ADVERSE EVENTSThe DuraSeal Dural Sealant System was evaluated in 120 investigational patients in the post-approval clinical study while 117 patients were treated with other commonly used techniques of dural closure. The following table presents any adverse event occurring at a rate of 1% or higher in these patients. Adverse Event rates presented are based on the number of patients having at least one occurrence of a particular adverse event divided by the total number of patients treated.
The incidence and nature of adverse events observed in this patient population are consistent with the type and complexity of the surgery performed and the co-morbid state of the treated patients.
AE categoryNote: Patient can experience more
than one AE
DuraSeal (N=120)
n(%)
Control (N=117)
n(%)p-value
Any Complication 20 ( 16.7) 22 ( 18.8) 0.735Superficial Incisional SSI 0 ( 0.0) 3 ( 2.6) 0.119
Deep Incisional SSI 2 ( 1.7) 0 ( 0.0) 0.498Organ/Space SSI 0 ( 0.0) 0 ( 0.0) -----
Late Incisional SSI 3 ( 2.5) 1 ( 0.9) 0.622Poor Wound Healing 0 ( 0.0) 1 ( 0.9) 0.494
CSF Leak 1 ( 0.8) 2 ( 1.7) 0.619Hydrocephalus 1 ( 0.8) 1 ( 0.9) 1.000
Meningitis (Bacterial) 0 ( 0.0) 0 ( 0.0) -----Meningitis (Aseptic) 0 ( 0.0) 1 ( 0.9) 0.494Pseudomeningocele 1 ( 0.8) 1 ( 0.9) 1.000Cerebral Hemorrhage 3 ( 2.5) 1 ( 0.9) 0.622
Cerebral Edema 2 ( 1.7) 0 ( 0.0) 0.498Cerebral Vascular Accident (stroke) 1 ( 0.8) 2 ( 1.7) 0.619
Other 13 ( 10.8) 14 ( 12.0) 0.840 Note: p-value is based on Fisher’s Exact test.
There were two reports of Deep Surgical Site Infections in the DuraSeal group and three reports of Superficial Infections in the Control group. The difference was not statistically significant between groups and in both cases of Deep Surgical Site Infections, the treating investigators identified the complications as being related to the procedure as a result of an infected bone flap that was subsequently removed.
Evidence of DuraSeal use with non-autologous collagen duraplasty materials:In a separate evaluation, preclinical and clinical testing of DuraSeal use with non-autologous duraplasty materials has been completed. A study was performed in a canine craniotomy model to evaluate the performance of DuraSeal when used in conjunction with commercially available collagen duraplasty onlay products to augment dural closures. The results of this study demonstrated a 100% improvement in intraoperative sealing success and an 83.3% reduction in postoperative CSF leaks in animals treated with DuraSeal in conjunction with collagen duraplasty compared to animals treated with collagen duraplasty alone. At reoperation, decreased dura mater-bone flap adhesion formation was documented in animals that had DuraSeal application to the duraplasty onlay. Histologically, the application of DuraSeal over the collagen duraplasty was not associated with neurotoxicity, delayed healing, degenerative changes, increased dura-brain adhesions, or impaired neodura formation.
A retrospective, multi-center, non randomized study was conducted to evaluate the safety of DuraSeal Sealant as an adjunct to sutured dural repair to provide watertight closure when used in conjunction with non-autologous duraplasty materials. The evaluation involved 3 sites within the United States. A total of 66 patients were identified who were treated with DuraSeal Sealant in conjunction with primarily collagen-based duraplasty (Retrospective Population).
The safety assessment was based upon the incidence rate of neurosurgical complications, (i.e., post-operative CSF leak, surgical site infection and meningitis) observed in the Retrospective Population, as compared to the incidence rate of these same complications observed in a subset of the patient population enrolled in the 111 patient study who were treated with DuraSeal Sealant in conjunction with autologous duraplasty (PMA Population; 50 patients).
The Retrospective and PMA Populations were similar with respect to patient baseline characteristics with the following notable exceptions; the Retrospective Population included substantially more patients with an ASA score of 3 or more, included a small subset of Clean-contaminated procedures (5%); whereas, the procedures performed within the PMA Population were all Clean procedures; and, a larger proportion of patients within the Retrospective Population underwent tumor resections as compared with the PMA Population. The mean durotomy length was slightly longer for the Retrospective Population than for the PMA Population. The number of supratentorial and infratentorial procedures varied between the Retrospective and PMA Populations with supratentorial procedures representing 59.1% and infratentorial procedures representing 37.9% of the Retrospective Population, while the PMA Population was 36% supratentorial procedures and 62% infratentorial procedures.
The Retrospective and PMA Populations each had a similar incidence of combination supratentorial and infratentorial procedures (3% and 2% respectively).
The post-operative CSF leak rate was 7.4% and 6.0% for the Retrospective and PMA Populations respectively. Only one late surgical site infection was noted within the Retrospective Population with an associated incidence rate of 1.5% compared with an overall infection rate of 6.0% for the PMA Population. There were no serious device-related adverse events or unanticipated adverse device effects noted for either population.
1 HOW SUPPLIEDThe components of the DuraSeal System are:
1a) DILUENT SYRINGE (BLUE LABEL) WITH BLUE CAP (1)
1b) POWDER VIAL (1)
1c) CLEAR PRECURSOR SYRINGE WITH WHITE CAP (1)
1d) PLUNGER CAP (1)
1e) SYRINGE HOLDER (1)
1f) APPLICATOR (1)
1g) SPRAY TIP (3)
DIRECTIONS FOR USEThe application procedure consists of three steps:A) Preparing the Blue Precursor,
B) Assembling the DuraSeal System Applicator; and
C) Hydrogel Application
Preparing the Blue PrecursorNOTE: Inspect the PEG powder vial to ensure the powder is free flowing, or can be loosened up by shaking. If the powder remains not free-flowing, discard the entire kit.
1. Open the pouch and introduce the polymer kit tray into the sterile field.
2. Once in the sterile field, remove the lid from the polymer kit tray.
3. Remove and discard syringe cap from diluent syringe (blue label).
4. Depress the threaded fitting of the vial cap (Figure 1).
5. Ensure red line is no longer visible (Figure 2).
6. Screw the diluent syringe to the powder vial and inject content into vial (Figure 3).
7. Gently shake the vial/syringe assembly until the powder is completely dissolved. The solution will turn blue (Figure 4).
8. Invert the vial/syringe assembly, and draw the vial contents back into the syringe (Figure 5).
9. Unscrew the syringe from the vial and discard the vial.
Assembling the DuraSeal System Applicator1. Remove syringe cap from clear precursor syringe.
2. Prior to attaching the syringes to the applicator, ensure syringe fluid levels are equal. If fluid levels are not equal, expel fluids out of syringes until equal.
3. Attach blue and clear precursor syringes to the applicator (Figure 6).
4. Attach the syringe holder which slides over both syringe barrels. Carefully attach the plunger cap to the plungers of both syringes without dispensing precursors into the applicator. Hold the syringes by the plungers while performing this operation so as to not deliver any of the precursors into the applicator (Figure 7).
5. Attach a spray tip to the applicator (Figure 8).
NOTE: Avoid touching the plunger cap before application to avoid inadvertent precursor injection and tip plugging.
Hydrogel ApplicationNOTE: Achieve hemostasis and minimize CSF outflow. Ensure that there are 2-3 mm margins around the durotomy edge and that the margins are clear of clots and fluids, hemostatic agents and loose connective tissue.
1. Position the applicator 2-4 cm from the target site. Apply firm even pressure to the center of the plunger cap to dispense the precursors. Rapid initial spraying, followed by a slower controlled rate is recommended. (Figure 9)
NOTE: While in the surgical field, whenever anatomically possible, briefly spray on gauze and without interrupting flow, move to the target site.
2. Continue applying the hydrogel until a thin (1 – 2 mm) coating is formed.
NOTE: If delivery is interrupted and the spray tip is plugged, remove the spray tip, wipe the applicator tip, attach a new spray tip and continue delivery.
NOTE: The blue color of the hydrogel aids in gauging thickness. As the thickness of the DuraSeal hydrogel increases to 2 mm, the fine epidural vasculature becomes less visible.
NOTE: Hydrogel application beyond the edges of the dural margin may be removed with scissors or mechanical disruption. Irrigation immediately after the sealant has solidified is permitted.
STORAGEThe DuraSeal Dural Sealant System should be stored at or below 77 °F (25°C).
