Endologix, Inc. (Endologix) has received US Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to begin a prospective, multicenter, randomized clinical trial for IntuiTrak endovascular delivery system for the Powerlink family of stent grafts. The system is a bilateral percutaneous approach to repair endovascular abdominal aortic aneurysm (EVAR)
Standard EVAR procedures require an open surgical cut-down of one or both femoral arteries for delivery system access and device deployment.
Percutaneous EVAR (PEVAR) procedures do not require an open surgical cut-down of either femoral artery, as access to the femoral artery is achieved via a percutaneous (across the skin) approach. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a percutaneous EVAR indication.
The company plans to initiate this first pivotal clinical trial for percutaneous EVAR in the first quarter of 2010. Based on the trial results, Endologix intends to submit a future PMA supplement for a broadened indication for the IntuiTrak endovascular delivery system to include PEVAR in suitable patients and will initiate widespread physician training programs on this technique.
John McDermott, president and chief executive officer of Endologix said: “The unique attributes of our products, including the ease-of-use and low-profile design of the IntuiTrak endovascular system, makes the percutaneous approach possible. In addition, our Powerlink System is the only endovascular stent graft that utilizes anatomical fixation, which has been shown in clinical trials to yield exceptional long-term patient outcomes.”
The trial will utilize a pre-close technique facilitated by the Prostar XL Percutaneous Vascular Surgical System or Perclose ProGlide Suture-Mediated Closure System, both made by Abbott. Up to 20 US clinical sites will enroll 150 patients in the randomized trial.
Over all, 100 patients will undergo PEVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients will undergo standard surgical cut-down EVAR. All patients will be treated with the IntuiTrak endovascular delivery system.