Medtronic has announced the availability of the Valiant Captivia Thoracic Stent Graft System for endovascular repair of aortic aneurysms in China, Japan and the United States.
The Valiant Captivia Stent Graft is approved by the FDA for endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a non-aneurysmal aortic diameter in the range of 18–42mm and non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm. The device’s approved indications in China and Japan are similar.
The Valiant Captivia Stent Graft System updates earlier generation devices by featuring an eight-peak crown that effectively secures the deployed device inside the aorta. It is also more flexible and conformable through the elimination of the longitudinal connecting bar found in other stent grafts.
Medtronic also announced on 8 May the completion of enrolment in the RESCUE clinical study of the Valiant Captivia Stent Graft System as a minimally invasive treatment for blunt thoracic aortic injuries. Data from the RESCUE clinical trial will be used to seek an expanded indication for the device to treat aortic transections. The study’s principal investigator is Rodney White, chief of vascular surgery at Harbor-UCLA Medical Center in Los Angeles, USA.
Fifty patients at 20 US sites were enrolled in RESCUE to investigate the safety and effectiveness of stent grafts for the treatment of blunt thoracic aortic injuries. Early results on the first 33 patients enrolled in the study were presented in late March at SIR 2012. All-cause mortality at 30 days, the study’s primary endpoint, was 12% for this patient group.
“Traditionally, the mortality rates associated with surgical repair of blunt thoracic aortic injuries range from 15 to 20%,” said Alan Matsumoto, professor and chair of the department of radiology and medical imaging at the University of Virginia Health System, Charlottesville, USA, and presenter of the data. “With this frame of reference, the early data from RESCUE is very encouraging. We look forward to reporting the final results on all 50 patients in the study at a major upcoming scientific medical meeting.”
RESCUE is one of several clinical studies of the Valiant Thoracic Stent Graft. Other Medtronic studies of this device include VALOR II and VIRTUE.