FDA Clears IntuiTrak Delivery System for the Powerlink AAA Device
October 27, 2008 – Last week the FDA approved the Endologix Inc. IntuiTrak Delivery System used for the minimally invasive deployment of the Powerlink stent graft, which is indicated for the endovascular repair of abdominal aortic aneurysms (AAA).
The company plans to conduct a limited market release over the next several months and expects a full commercial launch in the U.S. in the second quarter 2009.
IntuiTrak said it has a novel design and deployment mechanism that simplifies delivery of the unibody bifurcated Powerlink device. The low-profile delivery system features enhanced flexibility, advanced hemostasis control and a hydrophilic coating to facilitate smooth delivery, particularly in patients with limited or difficult vascular access. The delivery catheter has an integrated sheath to facilitate the introduction of ancillary devices during the endovascular AAA procedure. This feature avoids the need for exchanges, thereby having the potential to reduce procedure time, blood loss and minimize vessel trauma.
For more information: www.endologix.com