Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Valiant Captivia thoracic stent graft system for the treatment of type B aortic dissections.
This new indication expands treatment options for the challenging patient population by providing clinicians with a minimally invasive alternative to open surgical repair and medical therapy.
FDA approval is based on results from Medtronic' Dissection trial assessing the safety and efficacy of the Valiant Captivia system. The Dissection study was conducted at 16 sites in the US.
University of Pennsylvania in Philadelphia professor of surgery and director of the thoracic aortic surgery programme, Dr Joseph Bavaria said: "The trial we conducted shows that endovascular repair with the Valiant Captivia system provides a safe, effective and potentially life-saving treatment option for acute dissection patients."
Dr Bavaria has presented the 12-month data from the 50 patients evaluated in dissection at the 2014 annual meeting of the Society for Thoracic Surgery on 27 January 2014.
The dissection study has met its primary safety endpoint by achieving an 8% all-cause mortality rate at 30 days, which represents a three to four-fold mortality improvement over open surgical repair.
The trial also achieved 100% technical success and 100% coverage of the primary entry tear at implant.
Valiant Captivia system includes a unique proximal tip-capture mechanism that enables controlled deployment and accurate placement of the stent graft. The device is indicated for a variety of thoracic aortic lesions.
Based on independent conformability bench testing of multiple thoracic stent grafts, the Valiant stent graft is the only device that maintains complete apposition to the vessel wall regardless of angulation or oversizing.
Medtronic initially launched the Valiant stent graft in Europe in 2005. So far, the device has been implanted in around 50,000 patients worldwide.
Image: Medtronic's Valiant Captivia system for type B aortic dissections. Photo: courtesy of Medtronic Inc.