Medtronic is introducing its Valiant Captivia Thoracic Stent Graft in the U.S, China and Japan after receiving all the relevant regulatory clearances in those markets. The device, which received European approval back in October 2009, is indicated in the U.S. 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 18–42 mm and non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm.”
The Valiant Captivia features eight peaks and troughs on each metal support ring, and by getting rid of the longitudinal connecting bar, such as on the company’s older Talent Thoracic Stent, the device is made more flexible and easier to apply inside tortuous aortas.
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 today the completion of enrollment in an investigational clinical study of the Valiant Captivia Stent Graft System as a minimally invasive treatment for blunt thoracic aortic injuries. Data from this FDA-approved clinical research study, called RESCUE, will be used to seek an expanded indication for the device to treat aortic transections.
Fifty patients at 20 U.S. sites were enrolled in RESCUE to investigate the safety and effectiveness of stent grafts for the treatment of BTAI. Early results on the first 33 patients enrolled in the study were presented in late March at the 2012 Annual Scientific Meeting of the Society of Interventional Radiology. All-cause mortality at 30 days, the study’s primary endpoint, was 12 percent for this patient group.
“Traditionally, the mortality rates associated with surgical repair of blunt thoracic aortic injuries range from 15 to 20 percent,” said Dr. Alan Matsumoto, professor and chair of the department of radiology and medical imaging at the University of Virginia Health System in Charlottesville, Va., 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.”
Product page: Valiant Captivia Thoracic Stent Graft…
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