Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections

It’s Thoracic Week with the 50th holding of the Society of Thoracic Surgeons in Florida. Medtronic has taken the opportunity to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.

Background

Type B aortic dissection is a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body’s main artery has become torn along the innermost layer of the vessel wall.

Since its initial 2005 launch in Europe, the Valiant stent graft has been implanted in about 50,000 patients worldwide — more than any device of its kind. Indicated for a variety of thoracic aortic lesions, it features a unique proximal tip-capture mechanism, which enables controlled deployment and accurate placement of the stent graft. Based on independent conformability bench testing of multiple thoracic stent grafts, the Valiant stent graft is the only device that maintains complete apposition to the vessel wall regardless of angulation or oversizing.

The new indication is supported by the results of the U.S. Medtronic DISSECTION trial, and expands treatment options for this challenging patient population by providing physicians with a minimally invasive alternative to open surgical repair and medical therapy. The study results were presented at the aforementioned STS meeting by investigator, Joseph Bavaria, MD, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania in Philadelphia.

12-month data from the 50 patients evaluated across 16 U.S. Sites demonstrate safety and efficacy of the Valiant Captivia System in the treatment of dissections, with excellent technical success. 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.

The study complements numerous others and adds to the growing body of evidence in support of thoracic endovascular aortic repair (TEVAR) as a treatment for type B aortic dissection also includes other studies, many of which Medtronic has sponsored.

Investigator comments

Dr Bavaria said; “The trial we conducted shows that endovascular repair with the Valiant Captivia System provides a safe, effective and potentially life-saving treatment option for acute dissection patients.”

Company comments

“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,” said Tony Semedo, a senior vice president at Medtronic and president of the company’s Endovascular Therapies business. “That interest is evident in our ongoing support of various TEVAR studies.”

Source: Medtronic, Inc.

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