Upload
aloha
View
36
Download
0
Embed Size (px)
DESCRIPTION
PCI Unmet Clinical Needs. For SVG Distal embolisation No reflow High rate of restenosis For AMI / other thrombus loaded lesions Distal embolisation No reflow Patients with DES Late ST due to incomplete endothelialization Bleeding complications due to long term Plavix use. - PowerPoint PPT Presentation
Citation preview
For SVGDistal embolisationNo reflowHigh rate of restenosis
For AMI / other thrombus loaded lesionsDistal embolisationNo reflow
Patients with DESLate ST due to incomplete endothelializationBleeding complications due to long term Plavix use
PCI Unmet Clinical Needs
The Evolution of Stents
Bare Metal
Drug Eluting
1st
Generation
2nd Generation
MGuard Generation3rd
While addressing the restenosis problem, today's stent technology overlooks
the adverse effects of acute embolization
• Micron Circular Knitting Technology
• Net Material: Poly Ethylene Terephthalate (PET)
• Fiber diameter: 20 μm
• Aperture size at expanded state: ~180μm X 200μm
• System profile - 1.3mm
• Net secured to the distal and proximal end of the stent
About MGuard’s Technology
About MGuard’s Technology
• The stent is wrapped with the ultra-thin polymer meshed net
• The net is designed for maximal flexibility without compromising the strength of the fiber
• The net expands seamlessly when the stent is deployed
About MGuard’s Clinical Benefits
MGuard is designed to
1. Trap thrombotic material to protect bloodstream from embolic debris
2. Reduce vessel injury and restenosis rate
3. Maintain standard procedure
Injury lowered by MGuard
About MGuard’s Clinical Benefits
MGuard Lifelong Embolic Protection
• MGuard blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure.
• MGuard addresses the risk of suboptimal perfusion and no-reflow in occluded lesions.
About MGuard’s Clinical Benefits
Lower arterial wall trauma
• MGuard’s net diffuses the stent pressure, creating a snow shoe effect to lower vessel trauma and injury*.
• This leads to a reduction in restenosis compared to BMS**.
About MGuard’s Clinical Benefits
Maintaining standard procedure
MGuard’s standard crossing profile and dilatationpressures make deliverability and deployment equivalent to a conventional balloon inflated stent.
MGuard Trials
• Preclinical - Coronary Porcine Study
• MGuard FIM Trial
• The GUARD Trial - Brazil Multicenter Study
• The MAGICAL Study MGuard in Acute MI Trial
• iMOS – MGuard International Registry
Animal Trials
Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMS
Methods9 Swine with a total of 21 stents:5 MGuard, 6 BMS (control)6 Month FU
Trial ResultsNo animal morbidity No device thrombosisLow inflammatory response (0.8 ± 0.3 on a scale of 0-3) Low Schwartz injury score (0.15 ± 0.1)Exceptionally good endothelization (4 ± 0)
Preclinical Safety Study Histology: 30 Days Post-Implantation 10X
BMS MGuard
Injury Score
Inflammation Score
Neointimal Thickness
Primary endpoint: 30 days MACE
Secondary endpoints:
Device success
Procedural success
TIMI flow post procedure
6 Months MACE
6 Months Late Lumen Loss
Participating centers:
Eberhard Grube ; Helios Heart Center, Siegburg, Germany
Karl Eugen Hauptmann ; Trier, Germany
MGuard First in Man Study
• Protocol amended to obtain long term (> 1y) results – Results expected by April 2009
FIM Clinical Results
Case Report #1 - MGuard in SVG
• 78 year old female with history of hypercholesterolemia, hypertension, smoking and diabetes.
• Coronary artery bypass surgery in 1993 and presented with progressive angina (CCS-III).
• Coronary angiography revealed subtotal occluded (99%) vein graft to the Right Coronary Artery.
• 2 MGuard stents were implanted
• Procedural success with:
• No clinical adverse events
• No CPK rise
• No no-reflow post PCI
Case Report #1 - MGuard in SVG
Pre-PCI
POSTMGuard
Case Report #2 - MGuard in SVG with IVUS
• 60 year old male• Proximal SVG (1995) lesion• 4mm lumen diameter• 80% stenosis• 4X15 MGuard stent
Baseline
No ISA;
St expansion= 98.9%
6 months
No ISA;
% St obstruction = 17%
Case Report #3 - MGuard in Acute MI
Totally Occluded LAD The Thrombus Visible
Case Report #3 - MGuard in Acute MI
Final ResultThe procedure was completed with optimal results and an absence of any angiographic complications.
Stent :
Stent material: Stainless steel 316
Stent design: Low profile
Strut thickness: 100μm, low profile stent design.
Catheter:
Rapid exchange delivery system
0.014” guide wire compatible
Guiding catheter: 6F
Nominal Pressure: 6 atm.
Rated Burst Pressure: ≤ 3.0 mm: 16 atm. ≥ 3.5 mm: 14 atm.
Radio-opaque markers: Proximal and Distal
Balloon Characteristic: Semi - compliant
Usable Catheter Length: 1420 mm ± 20 mm
MGuard Technical Data