Medtronic (NYSE: MDT) this week touted positive safety and efficacy data for its Valiant Captivia Thoracic stent graft system.
The Dublin, Ireland-based company enrolled 50 patients for the IDE trial, which was conducted at 16 sites across the U.S.
Patients with acute complicated type B aortic dissection were treated with Medtronic’s stent graft system. Medtronic reported 79.4% freedom from all-cause mortality and that three patients required a secondary endovascular procedure related to the dissection.
The company also said that true-lumen diameter over the stented region remained stable or increased in 92.3% of participants.
An aortic dissection is a tear in an inner layer of the aorta, causing blood to surge between layers of the aorta. A type B dissection is a tear located in the descending aorta.
“Medtronic is committed to working with physicians to treat more complex aortic disease and improve the lives of patients,” vice president and general manager of Medtronic’s Aortic business Daveen Chopra said in prepared remarks. “The Valiant line of technology leverages decades of clinical experience in continuing to treat thoracic disease and has been used to treat more than 75,000 patients.”
“Evidence shows that patients with acute complicated Type B aortic dissections can be safely and effectively treated with thoracic endovascular aortic repair,” Dr. Ali Azizzadeh from the University of Texas Health Science Center said. “The Valiant Captivia System continues to produce positive outcomes through three years in a very challenging patient population.
