FDA approves Medtronic ’ s Valiant Navion thoracic stent graft

Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta. The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections. Medtronic said that the newly cleared Valiant Navion stent will enable patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs, and will open percutaneous procedures to patients who had previously been limited from them due to anatomical concerns. “Our focus at Medtronic continues to be on advancing the treatment of complex aortic disease to improve outcomes and extend life. This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair. This therapy is truly a testament to our more than 20 years of clinical and engineering insights, and we look forward to making it available to those in need,” aortic biz GM John Farquhar said in a prepared statement. The Valiant Navion is a low-profile version of the company’s Valiant Captivia thoracic stent system, and features both CoveredSeal and FreeFlo stent configurations. Approval for the stent system came based on 30-day primary endpoint analysis of 87 subjects in an international inve...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Regulatory/Compliance Stent Grafts Stents Vascular Medtronic Source Type: news