Medtronic (NYSE:MDT) said today it received CE Mark in the European union for its Valiant Navion thoracic stent graft system intended for use in minimally invasive procedures to repair lesions in the descending aorta.
The Fridley, Minn.-based company said that the device is cleared for use in treating thoracic aortic aneurysms, blunt traumatic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and type B aortic dissections.
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. Medtronic said that the Valiant Navion stent will allow 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.
Approval came based off a 30-day primary endpoint analysis of 87 investigational device exemption study subjects, which indicated a 2.3% rate of peri-operative mortality, a 2.3% rate of secondary procedures and a 1.2% rate of Type Ia endoleaks, Medtronic said.
“In clinical practice we often see patients with a wide range of thoracic aortic anatomies. For example, TEVAR in females doubles the risk of needing an adjunctive iliac access procedure1, which can potentially add risk, time, and cost to the procedure. The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients and those who were previously considered ineligible for TEVAR with a percutaneous approach,” Valiant Navion IDE study European principal investigator Dr. Fabio Verzini of Italy’s University of Turin said in a prepared statement.
Last month, the company won FDA approval for the Valiant Navion in the U.S.
“In just a few short weeks, we have achieved significant momentum with Valiant Navion – obtaining both FDA and CE Mark approvals. We’re proud to introduce the Valiant Navion system in Europe and believe in its potential to expand treatment options for physicians and patients with thoracic aortic disease,” Medtronic aortic biz GM John Farquhar said in a press release.