Wednesday, October 22, 2008

FDA Approves the Endologix, Inc. (ELGX) IntuiTrak™ Delivery System

Abdominal Aortic Aneurysms (AAA) is an aneurysm caused from a weakening of the wall of the aorta, the largest artery of the body. Aortic aneurysm disease is a leading cause of death in the United States and it is estimated that 1.7 million persons over 55 years of age have an AAA. Each year, physicians diagnose approximately 200,000 people in the United States with AAA. The overall patient mortality rate for ruptured AAA is approximately 75%.

IntuiTrak 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. Additionally, the delivery catheter has an integrated sheath to facilitate introduction. This feature avoids the need for exchanges, thereby having the potential to reduce procedure time, blood loss and minimize vessel trauma. The technology is a minimally invasive, allowing for greater patient comfort and quicker recovery compared to invasive surgical alternatives. Covered by 17 U.S. patents with 361 allowed claims, the technology is designed to overcome the significant shortcomings of first-generation ELGs.

“The procedural advantages of the IntuiTrak Delivery System, combined with the exceptional long-term clinical results of the Powerlink device, provide physicians with a compelling technology to treat their AAA patients,” said John McDermott, Endologix President and CEO. “We are excited to begin working with physicians on the training and roll-out of IntuiTrak and expect a full market release in the second quarter of 2009.”

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