FDA Approves Indication for Medtronic's Valiant Captivia to Treat Type B Aortic Dissections

January 28, 2014—Medtronic, Inc. (Santa Rosa, CA) announced it has received approval from the US Food and Drug Administration (FDA) for the Valiant Captivia thoracic stent graft system to be used in the treatment of type B aortic dissections. The new indication for the thoracic endovascular aortic repair (TEVAR) device expands treatment options for this challenging patient population by providing a minimally invasive alternative to open surgical repair and medical therapy.

Approval of the new indication is supported by the results of the DISSECTION trial. Joseph Bavaria, MD, Professor of Surgery and Director of the Thoracic Aortic Surgery Program at the University of Pennsylvania in Philadelphia, Pennsylvania, serves as a national principal investigator for DISSECTION.

In the company’s press release, Dr. Bavaria commented, “Acute type B aortic dissection is a potentially life-threatening condition that historically has been treated with either medical therapy or, when necessary, through invasive surgical techniques. 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.”

On January 27, Dr. Bavaria presented the 12-month data from the 50 patients evaluated in DISSECTION at the 2014 annual meeting of the Society for Thoracic Surgery in Orlando, Florida. Medtronic noted that the data demonstrate the safety and efficacy of the Valiant Captivia system in the treatment of dissections, with excellent technical success.

According to Medtronic, the DISSECTION trial was conducted at 16 sites in the United States. The trial met its primary safety endpoint by achieving an 8% all-cause mortality rate at 30 days, which represents a three- to fourfold mortality improvement over open surgical repair. Additionally, the trial achieved 100% technical success and 100% coverage of the primary entry tear at implantation.

DISSECTION investigator Rodney White, MD, Chief of Vascular Surgery at Harbor-UCLA Medical Center in Torrance, California, was the trial’s leading enroller. In the company’s announcement, he noted, “Data out to 1 year continue to show positive aortic remodeling of the stented segment with a 100% increase in true lumen volume and no ruptures.”

The company advised that the Valiant Captivia system is indicated for a variety of thoracic aortic lesions. The device features a unique proximal tip capture mechanism, which enables controlled deployment and accurate placement of the stent graft. The Valiant stent graft maintains complete apposition to the vessel wall regardless of angulation or oversizing.

Medtronic noted that the growing body of evidence in support of TEVAR as a treatment for type B aortic dissection includes the company’s landmark INSTEAD XL randomized controlled trial, which evaluated 140 patients with stable type B aortic dissections who were equally randomized to optimal medical therapy and TEVAR or to optimal medical therapy alone. In August 2013, Christoph Nienaber, MD, et al published the 5-year results from INSTEAD XL in Circulation: Cardiovascular Interventions (2013;6:407­–416). As reported by the investigators, INSTEAD XL demonstrated significant improvement in long-term survival, delayed disease progression, and fewer late complications with TEVAR plus medical therapy compared to medical therapy alone.

In addition to INSTEAD XL and DISSECTION, other clinical research on TEVAR that Medtronic has sponsored includes VIRTUE, a registry that is evaluating TEVAR patient outcomes by timing of diagnosis, and MOTHER, a TEVAR registry of more than 1,000 patients with a variety of pathologies that includes more than 300 patients treated for dissection.

In a related development, Medtronic recently expanded the size matrix of the Valiant Captivia thoracic stent graft system with 11 new proximal FreeFlo tapered pieces, increasing configuration possibilities by 30% to address a wider range of patient anatomies. The company stated that the line extension enables the Captivia system to be used in tapered aortas, which account for approximately 20% of all thoracic aortic aneurysm cases. The new pieces taper by 4 mm along their approximately 150-mm length and have proximal diameters that range from 26 mm to 46 mm.

Medtronic advised that these additional system components received FDA approval, European CE Mark approval, and Health Canada approval in January, but their approved indications vary by geography. In Europe, they are approved for use in treating thoracic aortic aneurysms, transections, and dissections; in the United States, for thoracic aortic aneurysms and transections; and in Canada, for thoracic aortic aneurysms.

In the company’s announcement, Matt Thompson, MD, the MOTHER registry’s primary investigator, commented, “The anatomy of the thoracic aorta is complex and unique to every individual. For patients with tapered aortas, TEVAR is not always straightforward and requires careful device sizing to ensure treatment success. The addition of tapered pieces to the Valiant Captivia system provides physicians with more options to confidently and effectively accommodate both straightforward and challenging anatomies.” Dr. Thompson is Professor of Vascular Surgery at St. George’s Hospital in London, United Kingdom.