Medtronic launches Abre stent iliofemoral venous outflow obstruction IDE study

Medtronic (NYSE:MDT) said today it launched an FDA investigational device exemption study of its Abre venous self-expanding stent system, looking to explore the use of the device in subjects with iliofemoral venous outflow obstruction. The first procedure in the study was performed last month by national principal investigator Dr. Erin Murphy of Charlotte, N.C.’s Sanger Heart & Vascular Institute, the Fridley, Minn.-based company said. “The launch of the Abre IDE Study marks the beginning of an important journey to establish new options for the treatment of deep venous disease. The first procedure was performed at Sanger Heart & Vascular Institute on a patient with Nonthrombotic Iliac Vein Lesion who is doing well post-treatment. We are excited to continue enrollment at our sites throughout the U.S. and Europe,” Dr. Murphy said in a prepared statement. Medtronic’s Abre stent is designed as a permanent implant in the iliofemoral vein, and comes pre-mounted on a 9 French delivery system. The device features a nitinol stent with a tri-axial shaft design, and uses an open-cell design with three connection points between cells, the company said. The multi-center, single-arm study aims to recruit 200 patients with deep venous disease, with a primary efficacy endpoint evaluating primary patency at 12 months and a primary safety endpoint evaluating the incidence of composite major adverse events at 30 days following stenting, Medtronic said. “D...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Stents Vascular Medtronic Source Type: news