On May 17, IDEV announced that data from a long lesion study of 182 patients with significantly diseased superficial femoral arteries and popliteal arteries showed high patency rates and no stent fractures after treatment with the Supera Veritas peripheral vascular stent system.
The data were presented at the Vaatdagen 2011 (Vascular Days) conference based on analysis by Andre Molenaar and Peter Haarbrink, interventional radiologists at Canisius-Wilhelmina Ziekenhuis (CWZ) hospital, a leading teaching and high volume medical centre in Nijmegen, The Netherlands.
The patients were treated and followed over a two year period, and represented an extremely challenging patient cohort with highly calcified and long lesions in the superficial femoral artery which at times encompassed the proximal popliteal artery and/or popliteal artery alone. What makes these results extraordinary was that they were achieved in vessels with significant disease and atypical extremely long lesion lengths with no Plavix used.
The superficial femoral artery plus proximal popliteal treated artery cohort consisted of 159 patients, with an average lesion length of 240mm, 40% Tasc D classification, and 57% total occlusions with an average of nearly two stents per patient. A high patency rate of 74% was achieved at 12 months as measured by duplex ultrasound. A group of 23 patients were treated with a Supera stent in the popliteal artery, with an average stent length of 142mm and a patency rate of 83% at 12 months, again measured by duplex ultrasound. A subgroup analysis by x-ray at 24 months showed no stent fractures. These data compare favourably to standard nitinol stent performance in patients with significantly shorter lesions.
“These are outstanding and noteworthy results which demonstrate that Supera is a market changing technology when used appropriately,” stated Molenaar. “The average stent length deployed was 240mm, ranging from 40mm to 550mm. Compared with other stent trials, and even the Leipzig Supera registry, these are much longer lesions with significant disease,” added Haarbrink.
Molenaar also stated that no concomitant treatment occurred with antiplatelet medication. “Patients received aspirin post procedure but none of these patients received Plavix following their stent procedures. We can assume the results would have had an even more dramatic improvement from baseline had we supplemented our procedure with this treatment. It is also clear to us that we utilise Supera for the most challenging cases, constantly testing the device and still receive exceptional results. We look forward to continuing our analysis of Supera.”
Christopher M Owens, president and CEO of IDEV Technologies commented, “We are pleased to see clinicians continue to independently evaluate the Supera stent in highly diseased patients. These extremely positive results reflect what we see on a continual basis in the marketplace.”