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S.M.A.R.T.® Vascular Stent Systems Receive FDA Approval for Use in SFA



  S.M.A.R.T.® Vascular Stent Systems Receive FDA Approval for Use in SFA

         First stent in the U.S. with both SFA and Iliac indications

Business Wire

BRIDGEWATER, N.J. -- November 08, 2012

Cordis Corporation today announced that the U.S. Food and Drug Administration
(FDA) has approved the S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in
the superficial femoral artery (SFA) and/or the proximal popliteal artery
(PPA). The S.M.A.R.T.® Stent, which has been approved for peripheral
indication in international markets since 1999, is now the first stent in the
Unites States with 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
revascularization (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 show 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).

"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."

In addition to the excellent clinical outcomes in the STROLL study, 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 (as
measured using Rutherford-Becker classification), and normal Ankle Brachial
Index (ABI) in 4 of 5 patients at 1 year.^1

“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.”

One of the most common vascular diseases, Peripheral Arterial Disease
(P.A.D.), occurs when leg arteries become narrowed or blocked by plaque. These
blockages can result in severe pain, limited physical mobility and non-healing
leg ulcers. According to the American Heart Association, approximately 10
million people in the U.S. suffer from P.A.D.

The STROLL study and the SFA indication for the SMART Stent represent the
latest commitments by Cordis to continue its groundbreaking work in the fight
against vascular disease.

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

About Cordis Corporation

Cordis Corporation, part of the Johnson & Johnson family of companies, is a
worldwide leader in the development and manufacture of interventional vascular
technology. Through the company's innovation, research and development, Cordis
partners with interventional cardiologists worldwide to treat millions of
patients who suffer from vascular disease. More information about Cordis
Corporation can be found at www.cordis.com.

*Defined as Rutherford-Becker classification 0 or 1.
Reference: 1. Data on file, Cordis Corporation.

Contact:

Media:
For Cordis Corporation
Sandy Pound
(o) 908-218-2720
(m) 908-432-2829
spound@its.jnj.com
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