Medtronic has received a CE mark for its low-profile thoracic endovascular aneurysm repair (TEVAR) endograft Valiant Navion.
The clearance, which comes weeks after FDA approved the device, positions Medtronic to market the device in Europe and work to expand use of TEVAR to new patient populations.
Medtronic designed the stent graft for use in patients with small iliac arteries.
Medtronic is on a roll. Having secured FDA approval for Valiant Navion last month, the medtech giant has quickly gained clearance to start selling the device in Europe. The back-to-back regulatory nods set Medtronic's commercial teams on both sides of the Atlantic to start pushing a device they think has an edge over rival products from Bolton Medical, Cook Medical and Gore Medical.
The evidence to support that thinking comes from an 87-person clinical trial. The study, which was the basis for the U.S. and European regulatory nods, tested the device in patients with small, calcified or tortuous access vessel arteries. One-third of subjects were women. Two-thirds had severe disease.
None of the procedures encountered access or deployment failures, resulting in the trial hitting its primary endpoint. Over the next 30 days, two subjects needed secondary procedures and two people died. Imaging follow-up at 30 days identified one subject with a Type 1a endoleak, an event defined by a gap between the graft and the wall of the vessel.
FDA saw the data as strong enough to support approval of the device, and the agency's peers in the European Union have followed suit. The question now is whether features such as the shortened, tapered delivery tip and use of multifilament, not monovalent, material will persuade surgeons to use the device and broaden the range of patients treated with TEVAR.
Fabio Verzini, European principal investigator for the Valiant Navion study, believes the new device can potentially expand the number of thoracic aortic disease patients treated.
"TEVAR in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure," Verzini said in a statement. "The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients."