IDEV announces release of SUPERA stent data from Leipzig Registry

IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced the release of two-year European data from the prominent 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, the SUPERA stent is currently being studied in an ongoing FDA approved IDE trial for treatment of peripheral arterial disease of the superficial femoral artery (SFA).

The single-center registry includes data from 107 patients treated for peripheral arterial disease of the SFA.  Within the study population, about a third of the patients had occlusions, 17 percent were categorized as Rutherford 4 or 5, and another 82 percent were Rutherford 3.  Additionally, half the treated lesions required placement of the SUPERA stent in the distal third of the SFA.  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.  

Results were presented by Sven Braunlich, MD of the Department of Angiology at Park Hospital and Heart Center, Leipzig, Germany during the 2011 Leipzig Interventional Course (LINC).  Key data points include a primary patency rate of 76 percent by duplex ultrasonography at two years with no stent fractures.  The 12-month patency rate was 85 percent, and the 18-month patency rate was also 76 percent, showing stable patency from 18 to 24 months.

Dr. Braunlich remarked, "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 SFA. X-ray screening, conducted at an average follow-up of 17 months, documented excellent durability of the SUPERA stent in the SFA, detecting zero fractures.  In addition, there was statistically significant improvement in ABI (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."

Kenneth Rosenfield, MD and Director of Cardiac and Vascular Invasive Services at Massachusetts General Hospital in Boston, is co-principal investigator of the IDE trial and was also on faculty at this year's LINC.  "The ongoing work at Leipzig, and the promising patency data reported in the Registry, helped establish the basis for the U.S. SFA trial.  We are encouraged by the Registry results, and look forward to completing enrollment in the SUPERB clinical trial in the first half of 2011," Rosenfield said.

"These latest data demonstrate that the SUPERA stent provides an excellent option for treating patients with peripheral arterial disease in the femoral-popliteal arteries, and may represent a paradigm shift in how these patients are treated," commented M. Laiq Raja, MD of El Paso Cardiology Associates, P.A. and Providence Memorial Hospital in El Paso, Texas.  He reviewed the long term data while attending LINC and added, "I am very impressed to see the zero percent fracture rate, and look forward to seeing the publication of these results later this year."

Eric Dippel, MD, of 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."

Christopher Owens, President and CEO of IDEV, said, "These patency results are outstanding.  The fact that patency scores are remaining at this level over an extended period reflect the unsurpassed durability,  strength and flexibility of the SUPERA stent, and reinforces that it truly represents a different class of stent.  We are excited about our expansion opportunities in Europe given the acceptance of these data and our market changing technology."

The independent testing referenced by Dr. 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 percent stronger crush resistance than standard nitinol stents. Throughout this testing, the SUPERA 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.