Meeting Highlights New Two-Year Data on IN.PACT Admiral DCB, First Report of Real-World TVT Registry with CoreValve System, First One-Year Data on Recapturable Evolut R, and Initial Results on First Implants of Drug-Filled Stent DUBLIN - October 6, 2015 - Medtronic plc (NYSE: MDT) today announced a preview of notable clinical studies that will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium, the world’s largest educational meeting specializing in interventional cardiovascular medicine in San Francisco from October 11-15, 2015.
“TCT is a proving ground for new technologies, and Medtronic is collaborating with leading physicians from around the world in an effort to share the latest clinical evidence across a variety of interventional therapies,” said Mike Coyle, executive vice president and president of the Cardiac and Vascular Group at Medtronic. “Together, we share a commitment to improving patient outcomes through minimally invasive procedures, and we look forward to showcasing our collective efforts as we advance healthcare through meaningful clinical data.”
The highly anticipated two-year results from the pivotal IN.PACT SFA clinical trial will be unveiled in a “First Report Investigation” presentation and also featured in a press conference on Wednesday, October 14, 2015. The two-year data is a follow up to the previously announced one-year data from the IN.PACT SFA clinical trial. The results will report patency out to two-years to investigate the durability and efficacy of IN.PACT® Admiral® for the interventional treatment of peripheral artery disease in the upper leg.
The two-year data will also be published simultaneously in the Journal of the American College of Cardiology (JACC), marking the first publication of two-year data evaluating the safety and efficacy of drug-coated balloons.
For transcatheter aortic valve replacement (TAVR), the agenda will feature several presentations that showcase rapid progression in the TAVR market:
• The one-year results from the CoreValve® Evolut R® System CE study will showcase clinical outcomes with the recapturable CoreValve Evolut R System.
• The first report of data from the Transcatheter Valve Therapies (TVT) Registry with the CoreValve System will reveal initial “real-world” outcomes with CoreValve.
• Several sessions will demonstrate the CoreValve System’s data from an Expanded Use Study evaluating performance in expanded patient populations, including patients with failed surgical aortic heart valves, end-stage renal disease and low gradient aortic stenosis.
For coronary stents, the Medtronic TCT agenda features new data on the next-generation Drug-Filled Stent, an investigational stent system that builds upon the proven platform of Continuous Sinusoid Technology and Core Wire Technology, innovations currently available on the Medtronic Resolute Integrity(TM) and Resolute Onyx(TM) DES systems.
Most notably, early results following first-in-human implants with the Drug-Filled Stent (DFS) will be unveiled for the first time. Using breakthrough engineering concepts in device design, preclinical data has shown that the novel, polymer-free DFS platform enables controlled and sustained drug elution into the arterial wall without a polymer carrier. A schedule of key presentations appears below in chronological order in U.S. Pacific Daylight Time.
Monday, October 12
• 12:15 p.m. - 1:45 p.m. / Featured Clinical Research I, Presentations to the Editors of the Journal of the American College of Cardiology (Moscone South, lower level, room 104)
o 12:30 p.m.: CoreValve US Extreme Risk: Evaluation of a Self-Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery
• 4:23 p.m. - 5:03 p.m. / Didactic Symposia, Metallic Drug-Eluting Stents: Tomorrow’s Technology. Session III, Polymer-Free Drug-Coated Stents (Moscone West, third floor, room 3001 - 3005)
o 4:37 p.m.: Drug-Filled Stent: Concept, Preclinical Studies, and Early Clinical Observations
Tuesday, October 13
• 2:00 p.m. - 4:00 p.m. / Oral Abstract Session, TAVR
o TAVR Part 1 (Moscone West, third floor, room 3022)
•
o
? 3:15 p.m., TCT 96: Self-Expanding TAVR in Patients With Failed Surgical Bioprosthesis - Six-Month Results From the CoreValve US Expanded Use Study
? 3:30 p.m., TCT 97: Transcatheter Aortic Valve Replacement Using the Self-Expanding Bioprosthesis - First Report From the Transcatheter Valve Therapies Registry
? 3:45 p.m., TCT 98: Clinical Outcomes at 1-Year With a Repositionable Self-Expanding Transcatheter Aortic Valve
o TAVR, Part 2 (Moscone West, third floor, room 3024)
•
o
? 2:15 p.m., TCT 100: Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease - One-Year Outcomes From the CoreValve US Expanded Use Study
• 4:00 p.m. - 6:00 p.m. / Poster Abstract Session
• Self-Expanding TAVR in Patients with Low-Gradient, Low Output Aortic Stenosis: 12 Month Results from the CoreValve US Expanded Use Study
Wednesday, October 14
• 12:00 p.m. - 12:30 p.m. / Plenary Session XXI. First Report Investigations 3 (Moscone South, Esplanade level, Main Arena)
o 12:15 p.m.: #2 FRI- IN.PACT SFA: A Prospective Randomized Trial of a Drug-Coated Balloon for Femoropopliteal Lesions - Two-Year Outcomes
• 1:00 p.m. - 2:00 p.m. / Medtronic sponsored DCB Symposium. IN.PACT SFA Trial Two-Year Outcomes: Will this Evidence Shift the PAD Treatment Paradigm? (Moscone North, lower level, Hall D, presentation theater two)
o 1:00 p.m.: Deep Dive: IN.PACT SFA Two-Year Outcomes
o 1:15 p.m.: Understanding the Science Behind the Latest Evidence
o 1:30 p.m.: Is this Evidence Practice Changing?
TCT Analyst and Investor Briefing
Medtronic will host a webcast to provide an update on its Cardiac and Vascular Group and Neurovascular business during the TCT conference on Wednesday, October 14, 2015, from 5:00 p.m. to approximately 7:00 p.m. PDT. The webcast will feature remarks from Medtronic management, including comments on Medtronic’s clinical data, product pipelines, and market outlooks. The live audio webcast will be available on October 14, 2015, by clicking on the Investors link on the Medtronic home page at http://www.medtronic.com. Within 24 hours of the webcast, a replay will be available under the Events and Presentations page in the Investors section of the Medtronic website. This event is not part of the official TCT symposium.
Details such as times, titles and locations are subject to change. Medtronic’s Drug-Filled Stent is available for investigational use outside of the United States only, and is not approved for use outside of clinical studies. The IN.PACT Admiral drug-coated balloon, the CoreValve Evolut R System and the CoreValve System are all approved for use in the United States.
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 more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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