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FDA grants AAA device first percutaneous indication
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Endologix has announced today that it has received FDA approval for broadening the indication of its endovascular abdominal aortic aneurysm repair systems to include totally percutaneous endovascular aneurysm repair.
The platforms in the approval include the IntuiTrak Powerlink system as well as the AFX endovascular abdominal aortic aneurysm (AAA) system. According to a company-issued press release, these are the first and only commercially available endografts to achieve the totally percutaneous labeling expansion, facilitating use of the Perclose ProGlideSuture-Mediated Closure System (Abbott).
The approval was based on the outcomes of the PEVAR prospective, multicenter, randomized clinical trial. In the trial, percutaneous endovascular aneurysm repair (EVAR) compared with surgical EVAR was completed in 34 minutes less time, required eight times fewer concomitant iliac/femoral artery procedures or repairs, and resulted in achievement of femoral artery hemostasis in 57% less time, according to the release.
The company plans to begin training US physicians on the percutaneous EVAR procedure in the second quarter 2013.