Long-Term European Data Support IDev's Supera Stent to Treat SFA

January 26, 2011—IDev Technologies, Inc. (Webster, TX) announced the release of 2-year European data from the Leipzig Registry, which tracks patients treated with the company's Supera wire interwoven nitinol stent. Sven Braunlich, MD, presented the results during the 2011 Leipzig Interventional Course in Germany.

According to IDev, the single-center registry includes data from 107 patients treated for peripheral arterial disease of the superficial femoral artery (SFA). In the study population, approximately one-third of the patients had occlusions, including 17% that were categorized as Rutherford 4 or 5 and 82% that 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 cm.

Key data points included a primary patency rate of 76% by duplex ultrasonography at 2 years with no stent fractures. The 12-month patency rate was 85%, and the 18-month patency rate was 76%, showing stable patency from 18 to 24 months.

“The SUPERA stent has been shown in independent testing to be extremely crush and fracture resistant compared to standard nitinol stents,” commented Dr. Braunlich. “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 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.”

In Europe, the Supera stent has received CE Mark approval for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use after failed percutaneous transluminal angioplasty. In the United States, the Supera stent is currently indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. Also, the Supera stent is being studied for treating peripheral arterial disease of the SFA in the ongoing SUPERB trial. Kenneth Rosenfield, MD, is coprincipal investigator of the trial.

“The ongoing work at Leipzig and the promising patency data reported in the Registry helped establish the basis for the US SFA trial,” commented Dr. Rosenfeld. “We are encouraged by the Registry results and look forward to completing enrollment in the SUPERB clinical trial in the first half of 2011.”