Fremont, Calif., October 8, 2012 – Cordis Corporation announced today three-year health related Quality of Life (QoL) data from the STROLL clinical trial that were presented during a Late-Breaking Clinical Trials session at the Vascular Interventional Advances (VIVA) 2013 Annual Meeting in Las Vegas. Results from the Quality of Life analysis showed that patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) treated with the S.M.A.R.T.® Vascular Stent Systems (S.M.A.R.T.® Stent) experienced clinically meaningful improvements in Quality of Life, including reduced pain in the affected leg(s), improved social function and increased walking distance, that were maintained over the three year study follow-up period.
An estimated 27 million people in Europe and North America alone suffer from PAD, which 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.
The Quality of Life analysis included the 250 patients studied in the STROLL clinical trial, a multicenter, prospective trial, which assessed the safety and efficacy of the S.M.A.R.T.® Stent. Patients enrolled in the trial had Rutherford Class 2-4 symptoms and were treated with standard percutaneous transluminal angioplasty with placement of one or more S.M.A.R.T.® Stents.
“These new findings show the quality of life benefit was very large and sustained over at least three years in patients with superficial femoral artery disease treated with S.M.A.R.T.® Stent,” said David Safley, MD, Consulting Cardiologist at Saint Luke's Mid America Heart Institute and Associate Professor of Medicine at the University of Missouri School of Medicine - Kansas City, who presented the data at VIVA on behalf of the STROLL Trial investigators. “Currently there are limited published reports evaluating the impact and durability of these types of treatments on patient-reported outcomes beyond one year, which makes these findings noteworthy to clinicians evaluating treatment options for PAD patients.”
The analysis evaluated health status and quality of life using validated patient assessment scales, including the Short Form 12 and EQ-5D (generic health status), the Peripheral Artery Questionnaire (PAQ) and Walking Impairment Questionnaire for PAD (specific health status). Quality of life was assessed on all patients at baseline, one, six, 12, 24, and 36 months.
At one month follow-up, there was significant improvement on the PAQ summary scale (mean change 31.4 points, p<0.001 vs. baseline; minimum clinically important difference = 8 points) as well as most other disease-specific and generic scales. Additionally, there was significant improvement on the PAQ summary scale as well as most other scales that were sustained through the three year follow-up (mean change 28 points, p<0.001).
“When coupled with the positive two year clinical outcomes reported earlier this year, which demonstrated minimal or no recurrence of lower extremity stenosis or occlusion in more than 80 percent of treated patients, with high patency and low target lesion revascularization rates, these impressive results further validate the use of the S.M.A.R.T.® Stent in the treatment of these patients,” said William A. Gray, MD, Director of Endovascular Services, Cardiovascular Research Foundation, New York. “We will continue to build on this robust data set with the presentation of the STROLL Trial three year clinical data at a future medical congress.”
The S.M.A.R.T.® Stent is available in the United States with both proximal popliteal artery and SFA indications and provides an unmatched balance of radial force, scaffolding, and longitudinal stability*. The company continues to build on the legacy of this platform with its recent addition of the new S.M.A.R.T.® Flex Stent, the next innovation in peripheral stents 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 vascular disease (iliac, SFA and popliteal) and received 510(k) clearance from the U.S. Food and Drug Administration for the palliative treatment of biliary strictures associated with malignant tumors.
"Based on both the long-term clinical and quality of life data, the benefits of treatment with the S.M.A.R.T.® Stent are compelling. We continue building on the attributes of the S.M.A.R.T.® Stent design with our next-generation, self-expanding stent platform – the S.M.A.R.T.® Flex Stent – an important new addition to our portfolio," said Celine Martin, Worldwide President, Cordis Corporation. "We are committed to addressing the unmet needs of patients worldwide with the development of less invasive therapeutic options."
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.
Dr. Gray is compensated for his services as a member of the company’s Scientific Advisory Board and provides other consulting services.
* Cordis data on file
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