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news.Incorporates novel design, delivery and deployment features and enables delivery of the Powerlink XL stent graft
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Endologix, a developer of minimally invasive therapies for the treatment of vascular disease, has received the FDA approval of the IntuiTrak express delivery system for the Powerlink XL stent graft.
According to Endologix, the IntuiTrak express incorporates novel design, delivery and deployment features and enables delivery of the Powerlink XL stent graft through the IntuiTrak 19Fr introducer sheath during the endovascular repair of abdominal aortic aneurysms in patients with aortic necks up to 32mm in diameter.
Approval of the IntuiTrak express provides additional treatment options to physician users and includes a 21Fr IntuiTrak stand-alone delivery system for the Powerlink XL stent grafts that incorporates its own integrated, hydrophilically coated introducer sheath with advanced hemostasis control, the company said.
John McDermott, president and CEO of Endologix, said: We believe this unique combination of a low-profile delivery system and the exceptional clinical results demonstrated in the Powerlink XL clinical trial offers a clear competitive advantage. We plan to conduct a limited market release with the IntuiTrak express over the next several months and expect a full commercial launch in the US in the third quarter of 2009.
Endologix develops and manufactures innovative therapies for aortic disorders and is focused on the development and marketing of technology for treatment of Abdominal Aortic Aneurysms.