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Summary from the Circulatory System Devices Panel Meeting - October 22, 2002

The 10/23/02 summary is available here.

A meeting of the Circulatory System Devices Panel was held on October 22 and 23, 2002. On October 22, the Panel discussed, made recommendations, and voted on a premarket approval application, Cordis’ Corporation CYPHER™ Sirolimus-Eluting Coronary Stent System (P020026). The device is a combination product, consisting of a permanently-implanted stent with a conformal drug/polymer coating and the CYPHER™ Delivery Catheter System. The stent is intended to reduce restenosis of de novo coronary artery lesions in patients with coronary artery disease. The company completed a clinical study with 1,058 patients randomized into two treatment arms: 533 patients received the Sirolimus-Eluting stent and 525 received a bare metal coronary stent. The CYPHER™ Sirolimus-Eluting Coronary Stent System reduced target vessel failure at nine months to 8.6% compared to a 21% rate for patients treated with the bare metal stent.

Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (8-0) that the application be found ‘approvable with conditions’. The Panel’s conditions included recommendations for five year follow-up of patients enrolled in the three principal clinical studies conducted to date, completion of a pharmacokinetic study and revisions to the patient and product labeling to include more information regarding the drug coating and reflect the vessel diameter (2.5 to 3.5 mm) and lesion length (15 to 30 mm) studied in the clinical trial.

Contact: Geretta Wood, Executive Secretary,
(301) 443-8320 ext. 143, gpw@cdrh.fda.gov

Transcripts may be purchased from: (written requests only)
Miller Reporting Company
735 8th Street, SE
Washington, DC 20003
(202) 546-6666 (voice), (202) 546-1502 (fax)
Or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 332-1726 (fax)

Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site:
http://www.fda.gov/cdrh/panelmtg.html

CDRH Advisory Committee Database

Updated 10/28/2002

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