IDEV Technologies announced the release of two-year European data from the Leipzig Registry, which tracks patients treated with the Supera wire interwoven nitinol stent. The Supera stent is CE marked for biliary and peripheral vascular use in Europe. In the United States, this stent is currently being studied in an ongoing FDA approved IDE trial for treatment of peripheral arterial disease of the superficial femoral artery.
Results were presented by Sven Braunlich, Department of Angiology at Park Hospital and Heart Centre, Leipzig, Germany during the 2011 Leipzig Interventional Course (LINC). Key data points include a primary patency rate of 76% by duplex ultrasonography at two years with no stent fractures. The 12-month patency rate was 85%, and the 18-month patency rate was also 76%, showing stable patency from 18 to 24 months.
The single-centre registry includes data from 107 patients treated for peripheral arterial disease of the superficial femoral artery. Within the study population, about a third of the patients had occlusions, 17% were categorised as Rutherford 4 or 5, and another 82% were Rutherford 3. Additionally, half the treated lesions required placement of the Supera stent in the distal third of the femoral artery. These highly diseased patients, with severely calcified lesions, had an average treated lesion length of approximately 11 centimeters, nearly double that in other stent trials.
“The Supera stent has been shown in independent testing to be extremely crush and fracture resistant compared to standard nitinol stents. Combined with the flexibility of the interwoven design, it is very well suited for use in the challenging superficial femoral artery. X-ray screening, conducted at an average follow-up of 17 months, documented excellent durability of the stent in the superficial femoral artery, detecting zero fractures. In addition, there was statistically significant improvement in ankle brachial index and Rutherford scores at all follow-up time points. These represent important clinical benefits to patients, and may translate into fewer repeat procedures,” Braunlich said.
Kenneth Rosenfield, director of Cardiac and Vascular Invasive Services at Massachusetts General Hospital in Boston and co-principal investigator of the IDE trial commented, “The ongoing work at Leipzig, and the promising patency data reported in the Registry, helped establish the basis for the US superficial femoral artery trial. We are encouraged by the Registry results, and look forward to completing enrolment in the SUPERB clinical trial in the first half of 2011.”
Eric Dippel, from Cardiovascular Medicine, P.C. at Trinity Regional Health System in Davenport, Iowa observed during LINC, “This is the longest follow-up data available for a novel stent that shows sustained excellent results. I am very impressed with the durability in the 18- to 24-month window.”
The independent testing referenced by Braunlich reported zero stent fractures for any Supera stent tested after 10 million cycles of 120 degree flexion and extension and 20 million cycles of torsion. Additionally, compression testing demonstrated a minimum of four times the radial strength and 360% stronger crush resistance than standard nitinol stents. Throughout this testing, the stent completely resisted fracturing, kinking, crushing, and crimping. In comparison, all standard nitinol tubular stents tested fractured before 100 thousand cycles in the flexion and extension testing and before 1 million cycles in the compression load testing.
The Supera stent is currently indicated in the USA for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.