Medtronic (MDT) Announces Strong, Three-Year Safety Data for Valiant Captivia TSG System

September 20, 2016 12:32 PM EDT

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Medtronic plc (NYSE: MDT) announced new data, demonstrating safety and efficacy at three years in acute complicated Type B aortic dissection patients treated with the Valiant® Captivia® Thoracic Stent Graft System. Ali Azizzadeh, MD, FACS, University of Texas Health Science Center in Texas presented the new clinical data in a late-breaking trial session at Vascular Interventional Advances (VIVA) 2016.

An acute aortic dissection is a serious condition in which the inner layer of the aorta tears, blood surges through the tear, and causes the inner and middle layers of the aorta to separate. This can result in aorta rupture or malperfusion of the vessels originating from the dissected aorta, leading to high morbidity and mortality. A type B dissection is a tear located in the descending aorta.

"Evidence shows that patients with acute complicated Type B aortic dissections can be safely and effectively treated with thoracic endovascular aortic repair (TEVAR)," said Dr. Azizzadeh. "The Valiant Captivia System continues to produce positive outcomes through three years in a very challenging patient population."

The FDA-approved Valiant Captivia System demonstrates continued safety and efficacy at three years. The data were gathered on 50 patients in the Medtronic Valiant Captivia Dissection IDE Trial, conducted at 16 U.S. sites.

Data highlights through three-year follow-up:

  • Freedom from all-cause mortality was 79.4 percent
  • Freedom from dissection-related mortality was 90.0 percent
  • No post-index procedure ruptures or conversions
  • True-lumen diameter over the stented region remained stable or increased in 92.3 percent, false-lumen diameter remained stable or decreased in 69.2 percent, and the false lumen was partially or completely thrombosed in 75.0 percent of patients
  • Three patients required secondary endovascular procedures related to the dissection

"Medtronic is committed to working with physicians to treat more complex aortic disease and improve the lives of patients," said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "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."

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

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