The Circulatory System Devices Panel met on September 11, 2000, to discuss, make recommendations, and vote on a premarket approval application, P000018, for the Novoste™ Beta-Cath System. The device is an intravascular brachytherapy system used to deliver radiation for the treatment of instent restenosis.
The Panel heard a presentation by Novoste on the results of the primary clinical study used to support the safety and effectiveness of the Beta-Cath System. The study, known as the STents And Radiation Therapy (START) trial, was a randomized, triple-masked, study in which 244 patients received treatment with the Beta-Cath System and 232 patients received an inactive placebo device. The primary effectiveness endpoint was target vessel failure. The primary safety endpoint was the incidence of Major Cardiac Adverse Events (MACE).
Following the FDA presentation, and a question and answer session, the Panel considered several discussion questions related to the PMA. In particular, FDA asked the Panel to:
- Make recommendations for antiplatelet therapy for patients receiving a stent and for those not receiving a stent;
- Discuss the clinical importance of the device failure and malfunction events;
- Discuss the risk-benefit analysis of the device;
- Recommend labeling modifications;
- Make recommendations for physician training; and
- Discuss the need for post-market evaluation of the device.
Following these deliberations, the Panel unanimously (9-0) voted to approve the device with the following Conditions:
- That the original cohort of patients in the START trial have continued follow-up for five years, and that an additional cohort of patients be studied post-market to more fully characterize the device failure and malfunction events;
- That the data be reanalyzed looking at the safety and effectiveness profile of just the 30-mm device, and to modify the labeling accordingly;
- That training be mandatory, and include demonstration of proficiency; and
- That labeling changes be made.
Contact: Megan Moynahan, Executive Secretary, (301) 443-8517 ext. 171, email@example.com
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