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TMCNet:  Three-Year Clinical Outcomes from STROLL Trial Demonstrate Sustained Durability and Performance of S.M.A.R.T.® Stent for Treatment of Peripheral Artery Disease

[January 21, 2014]

Three-Year Clinical Outcomes from STROLL Trial Demonstrate Sustained Durability and Performance of S.M.A.R.T.® Stent for Treatment of Peripheral Artery Disease

FREMONT, Calif. --(Business Wire)--

Cordis Corporation today announced three-year clinical outcomes from the STROLL Trial at the Abstracts and Late Breaking Clinical Trials session at the 26th Annual International Symposium on Endovascular Therapy (ISET). Results from the trial showed that patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) treated with the S.M.A.R.T.® Vascular Stent System (S.M.A.R.T.® Stent) experienced sustained clinical and quality of life benefits out to three years, including improvements in physical, psychological and social function.

"These results demonstrate that the S.M.A.R.T.® Stent performs well in patients suffering from peripheral artery disease three years after treatment," said Michael R. Jaff, D.O., lead author of the study and chair of the Institute for Health, Vascular and Stroke Care at Massachusetts General Hospital. "Patients had sustained improvements in walking distance and speed, and continued to experience enhanced health related quality of life."

In the study, the average lesion length was 77 mm, 23.6% of patients had total occlusions in the superficial femoral artery and 47% of patients were diabetic. At three years, freedom from clinically driven target lesion revascularization (TLR) was 78.5% and the primary patency rate was 72.3% by Kaplan Meier estimate. The stent fracture rate remained low at 3.6% and all stent fractures were Type I, least severe, with no incidents of more severe stent fractures (Type II-V). The mean ankle-brachial index (ABI) improved from 0.66±0.15 at baseline to 0.93±0.18 at one year and remained at 0.92±0.20 at three years. Patients in the STROLL Trial also experienced clinically meaningful improvements in patient reported Health Related Quality of Life (HRQOL), such as pain, walking distance and walking speed that wer maintained out to three years. At three years, there was significant improvement on the (Peripheral Artery Questionnaire) PAQ summary scale (mean change 28 points, p<0.001).


"We are very pleased that patients continue to feel better three years after treatment with the S.M.A.R.T.® Stent," said Celine Martin, Worldwide President, Cordis Corporation. "We are continuing to build on the legacy of this exceptional platform with our next generation S.M.A.R.T.® Flex Stent and look forward to delivering future innovations in self-expanding stents for patients suffering from peripheral artery disease."

The S.M.A.R.T.® Stent is available in the United States with iliac, proximal popliteal artery and superficial femoral artery indications and provides an unmatched balance of radial force, scaffolding, and longitudinal stability.*

The company continues to deliver on its commitment to address peripheral artery disease by building on the legacy of this platform in Europe with its new S.M.A.R.T.® Flex Stent, the next innovation in peripheral stents. The S.M.A.R.T.® Flex Stent is designed to optimize flexibility, fracture resistance and predictable placement while maintaining the tissue to metal ratio and radial strength of the S.M.A.R.T.® Stent. The S.M.A.R.T.® Flex Stent is CE Marked in Europe for the treatment of patients with vascular disease (iliac, SFA and popliteal). In the United States, the S.M.A.R.T.® Flex Biliary Stent System received 510(k) clearance by the U.S. Food and Drug Administration solely for use in the palliation of malignant strictures in the biliary tree. The safety and effectiveness of this device for use in the vascular system in the U.S. have not been established. The S.M.A.R.T.® Flex Stent is also being evaluated in an Investigational Device Exemption (IDE) study called the OPEN (News - Alert) Trial to determine its safety and effectiveness in the treatment of patients with atherosclerosis in the SFA, or SFA disease. Data from the trial is expected to support a Premarket Approval (PMA) application for an expanded indication to treat SFA disease in the U.S.

About Peripheral Artery Disease

Peripheral artery disease (PAD) is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys. An estimated 27 million people in Europe and North America suffer from PAD.

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 clinicians to treat millions of patients who suffer from cardiovascular disease worldwide. More information about Cordis Corporation can be found at www.cordis.com.

Dr. Jaff is a non-compensated advisor to Cordis and received no financial remuneration for his participation in this trial or presentation.

* Cordis data on file


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