The new approval allows Medtronic to market the minimally invasive device in treatment of type B aortic dissection, a "dangerous tear in the upper segment of the body’s main artery." The condition, which is associated with increased risk of death and injury, has traditionally been treated with drugs or invasive surgery, the company said.
Approval was granted based in part on the results of Medtronic’s DISSECTION clinical trial, which showed in 12-month data from 50 patients that the Valiant Captivia represented a 3- to 4-fold improvement in mortality when compared with open surgery. All procedures attempted during the trial were technically successful and the study met its endpoints for efficacy and safety, Medtronic reported.
Other studies of thoracic endovascular aortic repair, or TEVAR, have similarly reported positive outcomes, including from the randomized, controlled INSTEAD XL trial. That study evaluated 140 patients and produced 5-year results that demonstrated "significant improvement in long-term survival, delayed disease progression and fewer late complications" for TEVAR with drug therapy over drug therapy alone.
"We have an abiding interest in supporting high-quality studies that yield the clinical evidence required to characterize the long-term safety, efficacy and cost-effectiveness of our devices," Medtronic endovascular therapies president and senior vice president Tony Semedo said in prepared remarks."That interest is evident in our ongoing support of various TEVAR studies."
MDT shares closed last night at $57.09, a 0.2% increase on the day. Shares have lost 0.5% since the start of the year.