Perspectives from IndustryRAPID Working Group

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John Van Vleet

VP, Regulatory Affairs & Clinical Programs

Bard Peripheral Vascular, Inc.

Tempe, AZ

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• Urology

- Bard Medical Division

• Vascular

- Bard Peripheral Vascular, Inc.

- Lutonix, Inc.

- Bard Medical Division

• Oncology

- Bard Access Systems, Inc.- Bard Peripheral Vascular, Inc.- Bard Biopsy- Bard Medical Division

• Surgical Specialties

- Bard Medical Division- Davol Inc.

Key Disease Management Areas by Division

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Vascular• Bard Peripheral Vascular, Inc., Tempe, AZ

- Vascular Grafts- Angioplasty Catheters- Stents- Vena Cava Filters- Stent Grafts- Chronic Total Occlusion Crossing Devices

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Bard Peripheral Vascular Focus

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Peripheral Arterial Disease Venous Disease End-Stage Renal Disease Cancer

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• Alternative Strategies for Regulatory Approvals– ISS for Indication Expansion

• Where it just fell Short– Proposal to Address 522 Requirements

• Getting Closer– Proposal for fulfill PAS Requirements

• The Future – RAPID III

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Real-World Data - Bard’s Experience

• Traditional (Original) PMA’s Require Traditional Methods (i.e., pivotal study data)

• However, PMA Supplements provide opportunities for alternative strategies

– Design Modifications

– Indication Expansions

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Alternative Strategies – Pre-Market

• Design Modifications

– Smaller confirmatory studies

• Indication Expansions

– Pooling of Existing Data from a Variety of Sources

– Potential Use of Registry Data (VQI, RAPID?)

– Investigator Sponsored Study (ISS)

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Alternative Strategies – Continued

• Current ISS Proposal

– Multicenter, Randomized, Controlled Study for Indication Expansion of Vascular Stent

– Advantage of ISS: Non-biased, clinical need/question drove interest, 2 year follow-up

– Challenge: Less Oversight & Compliance (i.e., X-ray)

• Status Pending

– Perhaps use of registry core data elements would be a more streamline path for indication expansion

– Challenge: collection of non-SoC imaging • Risk Assessment – Increased Radiation Exposure vs. Device

Attribute Assessments

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Investigator Sponsored Study

Background

• FDA Issues 522 Order to Filter Manufacturers

• SVS/SIR initiate PRESERVE Study

• Manufacturers choice = Own 522 Study vs PRESERVE

• Bard enrolls Denali Filter in PRESERVE

• Was there an alternative with the SNF permanent filter with over 20 years of commercial experience?

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Proposed Post-Market Surveillance Plan to Address 522 Requirements

 Front View   T op View 

Bard-Sponsored 522

• Low usage is cost and time prohibitive

VQI PSO

• Existing IVC filter module

• Imaging requirements not SoC (non-starter)

PRESERVE

• 0.7% SNF usage rate seen in the VQI registry – 15 SNF filters expected out of 2100 planned enrollments in PRESERVE – Not an Option

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Options to Comply with 522 Order

• Collection of Pre-Market level imaging (non-Standard of Care) was required for ALL manufacturers

• In the end, existing registry options were not be a viable option to fulfill 522 requirements

• Completion of a traditional study would be necessary (PRESERVE not an Option)

• Conclusion, Bard withdraws a permanent filter option with over 20 years of market history

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Where the Registry Option Just Fell Short

• Back to the indication expansion on a vascular stent

• PAS will be required due to novel indication

• Negotiations pending to fulfill PAS requirements with existing registry elements (VQI)

• Challenge: Real-World Standard of Care Data vs. Typical PAS Requirements (i.e., non-SoC imaging)

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Getting Closer

Conclusion – Future of RAPID III

• A central set of agreed upon data elements for PAD is critical with the amount of devices available and in development

• Open collaboration between Global Regulatory Agencies, Physicians, Scientific Societies and Industry is essential

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