Medtronic has obtained regulatory clearance from the US Food and Drug Administration (FDA) for the expanded indication of use of its tubular stent graft for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta.
The Valiant Captivia system, which comprises a specially woven fabric sewn onto a flexible wire-mesh frame, is inserted using a catheter to pass up the aorta to treat transections (commonly known as blunt traumatic aortic injuries).
The approval is based on the positive results of 50 patient-based RESCUE trial, which met its primary endpoint with a 30-day all-cause mortality rate of 8.0%.
Harbor-UCLA Medical Center 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.
"When surgery is the only other option for repairing an aortic transection, the Valiant Captivia system can literally be a life-saver," White added.
The company is planning to present six-month results from the RESCUE trial later in this week in New York, US.