Medtronic received FDA approval to offer its Valiant Captivia Thoracic Stent Graft System as a treatment option for type B aortic dissections. The implant features eight peaks and troughs on each metal support ring, and not having a longitudinal connecting bar, such as on the Medtronic’s older Talent thoracic stent, it is more flexible for placement inside the aorta.
The system previously had FDA indication for treatment of aneurysms and penetrating ulcers of the descending thoracic aorta.
Some details of the trial that led to the approval:
Presented by Dr. Bavaria yesterday at the 2014 annual meeting of the Society for Thoracic Surgery, 12-month data from the 50 patients evaluated in Dissection demonstrate safety and efficacy of the Valiant Captivia System in the treatment of dissections, with excellent technical success.
Conducted at 16 U.S. sites, the trial met its primary safety endpoint by achieving an 8 percent all-cause mortality rate at 30 days, which represents a three- to four-fold mortality improvement over open surgical repair., Additionally, 100 percent technical success and 100 percent coverage of the primary entry tear at implant were achieved in the trial.