Meeting Highlights New Two-Year Data with Valiant Thoracic Stent Graft in Type B Aortic Dissection and Nine-Month Comparison Data in Leading Treatments for Peripheral Iliac Artery Disease
DUBLIN and LAS VEGAS - Nov. 2, 2015 - Medtronic plc (NYSE: MDT) today announced new clinical data in interventional treatments for aortic and peripheral vascular diseases in a late-breaking trial session at Vascular Interventional Advances (VIVA) 2015.
Valiant Captiva Demonstrates Safety and Efficacy at Two Years in Complicated Type B Aortic Dissection Patients
Positive two-year clinical data were presented today for the Valiant Captivia Thoracic Stent Graft System for the treatment of complicated type B aortic dissection. Type B aortic dissection is a serious cardiovascular condition associated with high morbidity and mortality in which the layers of the aorta (the body’s main artery) become separated from one another. The data were presented by Ali Azizzadeh, MD, FACS, University of Texas Health Science Center in Texas.
The FDA-approved Valiant Captivia System demonstrates continued safety and efficacy at two years. The data were gathered on 35 patients in the Medtronic Valiant Captivia Dissection IDE Trial, conducted at 16 U.S. sites. The one year outcomes in the trial were recently published in the Annals of Thoracic Surgery.
Data highlights:
• No post-index procedure ruptures or conversions through two years follow-up
• No new device related adverse events reported between the one and two year follow-ups
• No loss of stent graft integrity or stent graft collapse through two years follow-up
• At two years follow-up, true-lumen diameter over the stented region remained stable or increased in 85.7 percent, false-lumen diameter remained stable or decreased in 78.6 percent, and the false lumen was partially or completely thrombosed in 70.4 percent of patients
“There is a growing body of evidence supporting the use of thoracic endovascular aortic repair (TEVAR) as a safe and effective treatment for patients with acute type B aortic dissections,” said Dr. Azizzadeh. “The Valiant Captivia System has continued to produce positive patient outcomes at two years.”
Advances in Treatment of Peripheral Artery Disease (PAD); Comparing Self-Expanding Stents (SES) and Balloon Expanding Stents (BES)
John Rundback, MD, Holy Name Medical Center in New Jersey presented nine-month data from unique companion studies for patients with a diverse range of symptomatic iliac atherosclerotic disease. The presentation compared data from three Medtronic stents for the treatment of PAD in the DURABILITY Iliac + VISIBILITY Iliac study. The Protégé (TM) EverFlex(TM) Self-Expanding Stent System, the Protégé(TM) GPS(TM) Self-Expanding Nitinol Stent and Delivery Technology and the Visi-Pro(TM) Balloon Expandable Stent System.
In this comparison, the nine-month major adverse event rate was 1.3% for SES and 4% percent for BES, patency rates were similar between the two groups, both at 95.8%. These data demonstrate safety and effectiveness and comparative utilization patterns for balloon expandable stents and self-expanding stents in the treatment of iliac artery atherosclerosis.
Innovation on the Horizon: Endoanchors
With more to come at VIVA 2015, Medtronic will host a symposium on Wednesday at noon, “Developing a Standard of Care with Endoanchors: Translatable Treatment Algorithms From the Experts.” The symposium will feature new and recently acquired technology Heli-FX and Heli-FX® Thoracic EndoAnchor® systems, which feature an endovascular deployed anchor designed to attach a variety of aortic endografts to the native vessel wall.
“Medtronic is dedicated to solving healthcare challenges and going Further, Together to provide minimally invasive therapy options to improve patient outcomes. VIVA has continued to be an important stage for us in unveiling new clinical data on the latest innovations,” said Tony Semedo, president of the Aortic and Peripheral Vascular business at Medtronic. “Our commitment to clinical rigor and innovation in the aortic and peripheral vascular space is well displayed this week.”
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 that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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