1. Regulatory Considerations for Coronary Drug Coated Balloons – FDA View
Hina M. Pinto, MSE
Interventional Cardiology Devices Branch
Division of Cardiovascular Devices
Office of Device Evaluation
CDRH/FDA
CRT 2011, Washington, D.C.
March 1, 2011

2. Disclosure Information
No conflict of interest to report.

3. Drug-Coated Balloons (DCBs)
Hybrid technology
PTCA balloon + drug = Combination product
Regulated with CDRH as the lead center, with consultation to CDER
Primary mode of action is balloon dilatation of vessel
Class III/PMA

4. DCB Challenges
Balance amount of drug for effectiveness vs. acceptable safety profile
Local drug delivery and associated toxicities
Evaluate loss of drug during delivery (e.g., tracking)
Evaluate effects on safety & healing of the vessel (initially through the animal studies)
Determine the potential for larger drug doses in vivo with use of DCB (e.g., higher arterial tissue concentration)
Assess the potential for larger doses of drug to be released into bloodstream when DCB is inflated (vs. remain on DES)

5. DCB Pre-Clinical Testing
Bench testing
Adequate characterization of the coating and balloon
Animal Studies to assess safety
Drug toxicity
Amount of time the drug stays in arterial wall
Delayed, incomplete healing
Adequate characterization of how long the drug is in tissue will affect device evaluation and testing.
Complete characterization and testing is necessary even if the drug has been used for other indications (e.g., DES)
Adequate bench and animal studies to assess safety prior to human studies

6. DCB Clinical Considerations
Proposed Indication
ISR
de novo
small vessels
bifurcation lesions
Well-defined patient population
Based on DCB design and indication
Potential for multiple inflations of the DCB
Potential for the use of multiple DCBs clinically
Higher drug dose to patient
Although drug is rapidly delivered (acutely), the drug can remain in the tissue longer and could result in delayed healing.

7. DCB Clinical Considerations
Robust trial design (RCT)
Superiority or non-inferiority
Choice of control (e.g., approved DES)
Primary endpoint evaluation
Target lesion failure (TLF) rate
At least 9 month evaluation for ISR; (possibly 12 month for small vessels, bifurcations, etc.)
Longer term follow-up for DCB will likely be recommended.
Need to understand any long-term effects, potential for ST, and implications of recommended DAPT
FDA encourages you to discuss follow-up duration with us on an individual basis
Details of study design depend on clinical indication and DCB design.

8. DCB Summary
DCBs bring their own challenges in both science and regulation.
DCBs are not DES; DCBs are not PTCA catheters either.
Not permanent implants, but as the drug can form a depot in the tissue and be present beyond the in-hospital time period, healing and longer-term outcomes are important (vs. just acute).
Adequate characterization of the DCB will inform pre-clinical and clinical recommendations.
We encourage interactions early and often to identify appropriate pre-clinical considerations and clinical trial design.
IDEs often delayed due to preclinical issues (not clinical trial design concerns), so early interaction is critical.

9. Thank You. Hina M. Pinto (301) 796-6351 Draft Coronary DES Guidance
Draft Coronary DES Guidance
Class II Special Controls Guidance for PTCA Catheters