TriVascular Technologies' Ovation iX iliac stent graft gains FDA approval

TriVascular Technologies on Monday announced that the FDA approved its Ovation integrated exchange (iX) iliac stent graft for the Ovation Prime abdominal stent graft system, along with manufacturing enhancements to "facilitate a broader commercial launch of the product." The device maker added that the Ovation iX, which was developed to simplify use for physicians and to expand patient applicability, promotes patency "even in hostile anatomy."

According to TriVascular Technologies, the less-invasive, low-profile integrated sheath is designed to minimise vessel trauma. Further, the company said the broader size matrix, including flared limbs up to 28mm in diameter and limb lengths up to 160mm, enables treatment of a wider range of abdominal aortic aneurysm anatomies.

The Ovation iX iliac stent graft previously received CE mark clearance, the company said, adding that the Ovation Prime system is available in over 35 countries.

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