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FDA Clears Endologix PowerFit Aortic Extensions

Endologix, a developer of minimally invasive treatments for aortic disorders, has received FDA approval for its new PowerFit Aortic Extensions. The PowerFit is designed to provide physicians with enhanced visibility under fluoroscopy to facilitate precise device placement during completion of the Anatomical Fixation endovascular repair of abdominal aortic aneurysm (AAA).

In addition, PowerFit’s stent design and 24 circumferential contact points were shown in anatomical simulation studies to aid in proximal conformability and sealing.

PowerFit is designed for use with Endologix Powerlink main body bifurcated stent grafts and the IntuiTrak Endovascular System. PowerFit is expected to be available in a range of sizes indicated to treat aortic necks ranging from 18 to 32mm in diameter.

In addition, the PowerFit product line is expected to be available with longer stent lengths of up to 120 millimeters, to expand the treatment options for physicians and their patients. PowerFit will initially be launched through a limited market release during the third quarter of 2010, followed by a full US market release during the fourth quarter of 2010.

John McDermott, president and chief executive officer, said: “The new PowerFit line of aortic extensions enhances our expanding product offering, with the added benefits of improved visibility during placement and design features that facilitate anatomical conformability and sealing.

“In conjunction with anatomical fixation using the IntuiTrak Endovascular System, and our recently launched new sizes, Endologix offers a comprehensive product offering for the treatment of AAA. We look forward to the full US market launch of PowerFit and our new sizes during the fourth quarter.”