<a href=Medtronic” width=”300″ height=”146″ />

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.