The US Food and Drug Administration (FDA) has cleared the expanded use of Medtronic’s tubular stent graft for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta.
Comprising a specially woven fabric sewn onto a flexible wire-mesh frame, the Valiant Captivia system is inserted using a catheter to pass through several arteries in the abdomen and up the aorta to treat transections (commonly known as blunt traumatic aortic injuries).
The approval is based on the positive results of the 50 patient-based RESCUE trial, designed to assess the safety and efficacy of the stent graft.
The study met its primary endpoint with a 30-day all-cause mortality rate of 8.0%, according to the company.
The stent graft, which creates a new path for blood flow from top to bottom, also stabilises bleeding from descending thoracic aortic transections as an alternative to invasive surgery.
Harbor-UCLA Medical Centre vascular surgery chief and study principal investigator Dr Rodney White said the new indication of the Valiant Captivia stent graft system reduces the morbidity and mortality rates associated with surgical repair of transected aortas.
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“When surgery is the only other option for repairing an aortic transection, the Valiant Captivia system can literally be a life-saver,” White said.
The company is planning to present six-month results from the RESCUE trial later in this week in New York, US.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha’Eri.