New Approval Means Cordis Has First Stent In The U.S. With SFA And Iliac Indications

In short

J&J subsidiary, Cordis Corporation has announced that the U.S. FDA has approved its S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA).

Background

Peripheral Artery Diseases (PAD) is a frequent visitor to our pages, which puts it in the category of diseases or conditions that have some way to go before technology can be said to have conquered them. PAD is said to affect about ten million U.S. citizens and is characterised by blockages which can result in severe pain, limited physical mobility and non-healing leg ulcers.

Cordis’ S.M.A.R.T.® Stent has been approved for peripheral indication in international markets since 1999, is now the first stent in the U.S. to have its indication extended to include both Iliac and SFA indications.

The clinical data supporting the FDA approval of the S.M.A.R.T.® Stent for use in the peripheral vasculature was obtained through the STROLL Investigational Device Exemption (IDE) trial that enrolled 250 patients at 39 clinical sites within the U.S. In the study, freedom from clinically driven target lesion revascularisation (TLR) at one year was 87.4%. The 12-month primary patency rate for the S.M.A.R.T.® Stent was 81.7% by Kaplan Meier estimate. The study results showed no major adverse events at 30 days and a low one-year stent fracture rate of 2.0 percent. In addition, all stent fractures were Type I, least severe, and there were no incidents of more severe stent fractures (Type II-V).

Health-related Quality of Life (QOL) Surveys also showed an improvement in patient outcomes. This included minimal or no signs of PAD in 3 of 4 patients (Rutherford-Becker classification 0 or 1), and normal Ankle Brachial Index (ABI) in 4 of 5 patients at 1 year.1

Physician comments

“The STROLL trial demonstrates one year patency rates of ~81% and a very low fracture rate,” said Dr. William A. Gray, Director of Endovascular Services, Cardiovascular Research Foundation, New York, and co-national principal investigator of the STROLL study. “These outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery.”

Company comments

“We are very pleased to offer an expanded indication for the S.M.A.R.T.® Stent,” said Shlomi Nachman, Worldwide President, Cordis Corporation. “Our goal is to continue to make expanded indications and new products available to our customers so they may bring these innovations to their patients.”

Note: Dr. Gray is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.

Source: Cordis Corporation, Business Wire