ENCOR ENSPIRE® and ENCOR ULTRA® Breast Biopsy SystemsINDICATIONS: The ENCOR ENSPIRE® and ENCOR ULTRA® Breast Biopsy Systems are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

CONTRAINDICATIONS: The ENCOR ENSPIRE® and ENCOR ULTRA® Breast Biopsy Systems are contraindicated for those patients where there is an increased risk ofcomplications associated with percutaneous removal of tissue samples.

WARNINGS: The ENCOR ENSPIRE® and ENCOR ULTRA® Breast Biopsy Systems must be properly grounded to ensure patient safety.• Use of accessories not compatible with the ENCOR ENSPIRE® and ENCOR ULTRA® Breast Biopsy Systems may create potentially hazardous conditions.

PRECAUTIONS: This equipment should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.• Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.• As with any biopsy instrument, there is a potential for infection.

POTENTIAL COMPLICATIONS: Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection.Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound,pain and tissue adherence to the biopsy probe while removing it from the breast.

Please consult package insert for more detailed safety information and instructions for use.

Linda B. Griska, M.D. Megha Garg, M.D., S. Chace Lottich, M.D. and Jason Hechtman, M.D., F.A.C.S. are currently consultants for Bard Biopsy Systems.

바드코리아(주) 06236 서울특별시 강남구 테헤란로 142, 아크플레이스 16층 T. 02-2188-2900 F. 02-719-3081

The ® Breast Biopsy System obtained samples up to 150% larger than other systems in simulated use testing1

Percentage Greater Tissue Mass with Comparable ENCOR® Probe

7 G ENCOR� Probe

8 G Mammotome™

10 G ENCOR� Probe

11 G Mammotome™

Approximately

40%*LARGER

10 G ENCOR� Probe

9 G ATEC™/Eviva™

12 G ENCOR� Probe

12 G ATEC™/Eviva™

Average Tissue Sample (grams)0 .05 .10 .15 .20 .25 .30 .35 .40

Approximately

60%*LARGER

Approximately

35%*LARGER

Approximately

150%*LARGER

11g Probe

4.5mmdiameter

Specimen.10 grams

Vacuum

Mammotome™

Probe

Average Sample Size (grams)

Device Large Medium Small Gauge Gauge Gauge

Bard Biopsy ENCOR® Probe2 0.39 0.25 0.13

Hologic™ ATEC™/Eviva™ Probe3 0.18 0.08

Devicor™ Mammotome™ Probe4 0.28 0.10

10g Probe

4.2mmdiameter

Specimen.25 grams

ENCOR® Probe

1. STUDY DESCRIPTION: Conducted by Bard Biopsy Systems, the study included the EnCor Enspire® Breast Biopsy System, Hologic ATEC™ System, Hologic EVIVA™ System, and Devicor Mammotome™ System. Five (5) probes for each probe type/gaugesize were used to acquire 12 samples each (for a total of 60 samples) in chicken breast. To measure the inner diameter of the probes, needles were disassembled to access the cannula containing the sample notch. The inner diameter of the sample notchwas measured using pin gages. STUDY DISCLOSURES: Please note that these values are representative for comparison purposes. Performance in human breast tissue will vary. Different patients/densities and consistency of breast tissue will have adifferent yield in tissue sample mass. Gauge sizes listed are manufacturer-stated gauge sizes and do not necessarily represent the actual measured gauge size.2. EnCor® probes sizes: large gauge - 7g; medium gauge - 10g; small gauge - 12g.3. ATEC™ and Eviva™ probe sizes: large gauge - n/a; medium gauge - 9g; small gauge - 12g.4. Mammotome™ probe sizes: large gauge - 8g; medium gauge - 11g; small gauge - n/a.

BPV/VABE/0317/0016

The sharp tip is designed to:> Facilitate advancement and control> Reduce penetration pressure and improve targeting> Reduce drag and enhance patient comfort

Per the Instructions For Use: Care must be taken when positioning the device trocar tip near the chest wall or skin margin.Please consult package insert for more detailed safety information and instructions for use.

Linda B. Griska, M.D., Director of Breast Health Services, Abington Health Medical Director, Mary T. Sachs Breast Center

Jason Hechtman, M.D., F.A.C.S., Medical Director, The Breast Institute at Brandon Regional Hospital

“The ® Breast Biopsy System cuts like a knife.”

BPV/VABE/0317/0016

Half-sample mode can be activated by the touch of a button.

Half-sample mode may improve access to lesions

The touch screen allows the user to pre-select sampling patterns and monitor sampling progress during the procedure.

Sample automation helps acquire samples with less repositioning

Dense tissue mode can be activated by the touch of a button without the need to change any equipment mid-procedure.

Dense tissue mode is designed to obtain quality samples

“What is great about the half-sample feature is the fact that after you’ve inserted the needle and realized the aperture is too large, you can simply switch to the half size mode and proceed with the biopsy with no added cost or inconvenience for the patient.”

S. Chace Lottich, M.D., Community Breast South Hospital, Indiana Surgeon

Per the Instructions For Use: When performing a biopsy with EnCor® and EnCor® MRI Probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to initiating the procedure,confirm that the sample notch orientation is correct for the image guidance being used. Please consult package insert for more detailed safety information and instructions for use.

BPV/VABE/0317/0016 BPV/VABE/0317/0016

Design differences – contrast dye delivery testing performed in chicken breast

Hologic™ Eviva™

®

Bench test results may not be indicative of clinical performance.

Fluid dynamics comparison

Hologic™ Eviva™

Hologic’s Eviva™

to the saline line that runs between the needle and the coaxial cannula.

needle towards the collection canister.

The design of the ENCOR® Probe creates a one-way path and allows for delivery

®

Breast Biopsy System

BPV/VABE/0317/0016 BPV/VABE/0317/0016

After cassette clicks into place, connect tubing cassette to canister.

A snap-in tubing cassette eliminates manual threading.

Unique features enhance procedural

patient experience.

Intuitive touch screen interface helps reduce

Patient focus enhanced Fast set-up

Improved performance

“One thing I constantly hear from patients is ‘Really, is the biopsy over? I thought you were justgetting started.’ To most, the numbing seems to take more time than the biopsy itself.”

Megha Garg, M.D., Director of Breast Imaging, Elllis Fischel Cancer Center, University of Missouri - Columbia

“Automation makes my biopsy procedures faster—and I don’t have to rotate my wrist.When you do as many biopsies as I do, your wrist can start hurting by the end of the day.”

Jason Hechtman, M.D., F.A.C.S., Medical Director, The Breast Institute at Brandon Regional Hospital

Hologic EVIVA™ Probe1.33 Pounds

Hologic ATEC™ Probe1.12 Pounds

Devicor Mammotome™ Probe 0.50 Pounds

67%REDUCTION

60%REDUCTION

11%REDUCTION

® Probe0.44 Pounds

“I have found that the ENCOR ENSPIRE® Breast Biopsy System disposables are smallerand since I have gone from the Mammotome™ to the ENCOR ENSPIRE® Breast Biopsy

System my disposables have gone down and my cost has gone down.”Jason Hechtman, M.D., F.A.C.S., Medical Director, The Breast Institute at Brandon Regional Hospital

5. Data represents average weight of 5 samples. The probes used for comparison were the largest gauge size available for each console system.Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. OSHA C29 CFR 1910.1030(d)(4)(iii)(C)