The Circulatory System Devices Panel met on April 23, 2001, to discuss, make recommendations, and vote on a premarket approval application, P000033, for the Sulzer IntraTherapeutics IntraCoil® Self-Expanding Peripheral Stent. The device is a peripheral stent used in the treatment of stenotic or occluded femoral and/or popliteal arteries.
The Panel heard a presentation by Sulzer IntraTherapeutics on the results of the primary clinical study used to support the safety and effectiveness of the IntraCoil stent. The study was a prospective, multi-center, randomized study in which 135 patients received the IntraCoil stent and 131 patients received percutaneous transluminal angioplasty (PTA). The primary endpoints were the incidence of Major Adverse Cardiac Events (MACE) and angiographic restenosis of the target vessel at nine months.
Following the FDA presentation, and after questioning the sponsor, the Panel considered several discussion questions related to the PMA. In particular, FDA asked the Panel to:
- Comment on the sponsor’s use of suboptimal pre-dilatation classification as a surrogate for suboptimal results with PTA;
- Discuss whether adequate data were available to support a primary stent indication for the device;
- Discuss whether the clinical data were adequate to determine the safety and effectiveness of the stent when used in the popliteal artery;
- Make labeling recommendations; and
- Identify any items that should be contained in a physician’s training program for the device.
Following these deliberations, the Panel unanimously (9-0) voted that the application be found ‘not approvable’, citing a lack of conclusive evidence supporting the sponsor's claim of safety and effectiveness of the device when used following suboptimal balloon angioplasty. The Panel suggested that the application could be improved by prospectively studying this specific patient cohort, looking at longer-term results, and/or by having more complete patient follow-up data.
Subsequently, the Panel heard presentations by FDA and members of the clinical community on clinical trial design issues for peripheral stents used in the treatment of stenotic or occluded iliac arteries. The Panel made recommendations to the Agency on the types of trials, conveying their acceptance of the possibility of device registries for these products and advocating a multi-disciplinary effort to develop objective performance criteria for these studies.
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