Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Endologix percutaneous AAA study: Enrollment begins in firm's multi-center, prospective, randomized trial of the PowerLink stent graft in percutaneous endovascular abdominal aortic aneurysm repair (PEVAR), Endologix announces April 14. The study will enroll up to 150 subjects at 20 U.S. sites. All patients will be treated with PowerLink, delivered on Endologix' IntuiTrak system, but 100 will undergo PEVAR, while 50 will undergo standard endovascular AAA repair. Investigators also will use a "pre-close" technique on the PEVAR patients, facilitated by Abbott Vascular's ProStar XL percutaneous vascular surgical system or Perclose ProGlide suture-mediated closure system. PEVAR does not require an open surgical cut-down of the femoral arteries like standard EVAR, since access is achieved via a percutaneous approach. Endologix notes that there are no devices currently in clinical trials or approved by FDA for a PEVAR indication