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|Medtronic Drug-Coated Balloon Sustains Superiority Over Balloon Angioplasty at Two Years in Patients with Peripheral Arterial Disease|
Presented at TCT and Published in JACC, Two-Year Outcomes Reinforce IN.PACT Admiral's Durability, Consistency and Safety as a Best-in-Class Treatment Option for PAD
DUBLIN and SAN FRANCISCO - October 14, 2015 - Medtronic plc (NYSE: MDT) announced today that new two-year clinical data from the pivotal IN.PACT SFA Trial revealed that the IN.PACT® Admiral® drug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries). The data was presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference during a "First Report Investigation" session and also published simultaneously in the Journal of the American College of Cardiology (JACC).
"The IN.PACT Admiral DCB has produced consistently strong clinical results over the longer-term. At two years, the IN.PACT Admiral DCB showed strong patency and very low target lesion revascularization rates," said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center, co-principal investigator for the IN.PACT SFA Trial and first author of the published results in JACC. "These data results continue to validate this DCB as the durable, safe and primary treatment option, and are poised to impact the current SFA treatment paradigm."
"As clinicians continue to seek the best treatment strategies for patients with peripheral artery disease, we investigated, and published findings in JACC, a DCB device that has produced consistent clinical results across all key subgroups and trials," said Michael R. Jaff, D.O., Paul and Phyllis Fireman Chair in Vascular Medicine at the Massachusetts General Hospital, medical director of VasCore, the Vascular Ultrasound Core Laboratory, professor of medicine at Harvard Medical School and senior author of the published results in JACC. "The consistency and durability of the DCB, combined with the benefit of not leaving a stent in the artery, make this a significant option for treating SFA disease."
In a subgroup analysis from the IN.PACT SFA Trial, two-year results also showed clinical superiority and consistency across various patient types that have been proven difficult to treat based on historical data, including people with diabetes and the female population.
"The IN.PACT Admiral DCB's cadence of strong clinical data not only demonstrates the therapy's sustained durability, but also our deep-rooted commitment to providing innovative technologies that advance healthcare together in partnership with clinicians worldwide," said Brian Verrier, vice president and general manager of the Peripheral franchise, within the Aortic and Peripheral Vascular business at Medtronic. "We look forward to unveiling additional new data on the device at VIVA."
New two-year health economic data from the IN.PACT SFA Trial U.S. cohort and one-year data from the IN.PACT Global Study in-stent restenosis (ISR) cohort are forthcoming and will be presented at the Vascular Interventional Advances (VIVA) 2015 conference on Monday, November 2.
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 IN.PACT Admiral Drug-Coated Balloon
IN.PACT Admiral DCB received the CE (Conformité Européene) mark in 2009 and approval by the U.S. Food & Drug Administration in December 2014. It is the most studied drug-coated balloon to date. Medtronic is conducting four Medtronic-sponsored studies which include IN.PACT SFA, IN.PACT Global, IN.PACT Japan and IN.PACT China to assess the safety and effectiveness of the IN.PACT Admiral DCB. In addition, Medtronic is supporting approximately 20 physician-initiated DCB studies. In total, data on more than 4,000 patients treated with the IN.PACT Admiral DCB will be available.
Note: Dr. John Laird, MD is an advisor and paid consultant for Medtronic. Dr. Michael Jaff, DO is a non-compensated advisor to Medtronic.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.