Medtronic, along with Sanford Health, has started a clinical trial to evaluate its Valiant TAAA stent graft system for minimally invasive repair of thoracoabdominal aortic aneurysm.
An aortic aneurysm is a dangerous bulge or ballooning in a segment of the wall of the aorta, which can rupture and cause sudden death if left untreated.
The first patient has been enrolled in the study to assess the safety and efficacy of the Valiant TAAA stent graft system.
Sanford Health physician Dr Patrick Kelly has carried out the first procedure in a 58-year-old female under investigational device exemption trial approved by the US Food and Drug Administration (FDA).
Dr Kelly developed the concept for the system, while Sanford Health holds the intellectual property covered by the exclusive patent license agreement with Medtronic.
Kelly said: "The mortality rate is 25% when treating a thoracoabdominal aortic aneurysm with an open surgical technique, which involves cutting open the aorta."
The Valiant TAAA stent graft system provides physicians with better option to treat patients with severe and challenging aortic disease.
It is intended to allow for an off-the-shelf endovascular solution to one of surgery’s most difficult pathologies, according to the company.
Medtronic aortic and peripheral vascular division aortic business general manager and vice-president Daveen Chopra said: "As the first patient treated with the minimally invasive Valiant TAAA recovers, we are inspired by the innovators that continue to challenge the limitations of current treatment options."
Image: Medtronic has started a clinical trial to assess its Valiant TAAA stent graft system. Photo: courtesy of Medtronic plc.