Clinical Data for DURABILITY II Study Presented at ISET 2012; Met Predetermined VPI Performance Goals

Covidien COV today announced that one-year results on the use of its EverFlex™ stent for superficial femoral artery stenting were presented here during the International Symposium on Endovascular Therapy Conference. One of the most common vascular diseases, peripheral arterial disease (P.A.D.) occurs when leg arteries become narrowed or blocked by plaque. These blockages can result in severe pain, limited physical mobility and non-healing leg ulcers. According to the American Heart Association, approximately 10 million people in the U.S. suffer from P.A.D. DURABILITY II enrolled patients with lesions up to 18 cm in length; its primary endpoints were 30-day major adverse event rate and primary patency at one year, compared to performance goals published by VIVA Physicians Inc. (VPI). The mean age of subjects was 68 years, with 66 percent male. Prominent comorbidities included hypertension (88 percent), hyperlipidemia (86 percent), and diabetes (43 percent). The mean lesion length as measured by core laboratory was 89.1 mm, while the mean normal-to-normal lesion length measured by sites was 109.6 mm. No major adverse events occurred at 30 days. Primary patency at one year was 67.7 percent when analyzed by simple proportions of patients patent; using Kaplan-Meier time-to-event analysis, it was 77.2 percent. The results met predetermined VPI performance goals. The one-year stent fracture rate was 0.4 percent.