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news.Endologix has received the FDA's approval for the IntuiTrak delivery system. This new system will be used for the minimally invasive delivery and deployment of the Powerlink stent graft, which is indicated for the endovascular repair of abdominal aortic aneurysms.
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According to the company, 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, added Endologix.
Additionally, the delivery catheter has an integrated sheath to facilitate the introduction of ancillary devices during the endovascular abdominal aortic aneurysms (AAA) procedure. This feature avoids the need for exchanges, thereby having the potential to reduce procedure time, blood loss and minimize vessel trauma, the company said.
The company plans to conduct a limited market release over the next several months and expects a full commercial launch in the US in the second quarter of 2009.
John McDermott, president and CEO of Endologix, said: “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. We are excited to begin working with physicians on the training and rollout of IntuiTrak and expect a full market release in the second quarter of 2009.”