|Medtronic CoreValve® Evolut(TM) R System Yields Exceptional Outcomes in First Clinical Study|
No Mortality or Stroke at 30-days and Excellent Procedural Results with Next-Generation Recapturable Valve
DUBLIN and SAN DIEGO - March 14, 2015 - Medtronic plc (NYSE: MDT) today announced initial clinical outcomes for its next-generation CoreValve® Evolut(TM) R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology (ACC.15). The CoreValve Evolut R System is not approved for commercial use in the United States where it is currently undergoing clinical trials.
"Initial clinical experience with the Evolut R system is remarkable and ushers in a new era of TAVR technology that provides increased confidence with recapturability, excellent procedural results, and impressive clinical outcomes," said Ian Meredith, M.D., of Monash Heart - Monash Health, Melbourne, Australia, who is one of the investigators of the study. "The 14 French equivalent delivery system allowed transfemoral access for most patients and the recapturable technology enabled implanters to optimize valve placement for improved annular sealing and reduced conduction disturbances without compromise on mortality or stroke."
The new EnVeo(TM) R Delivery Catheter System provides a new InLine(TM) Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch). Transfemoral access was possible in all but one patient (98.3 percent) in a population that included patients with vasculature as small as 5.0mm diameter. Physicians took advantage of the new capabilities of the CoreValve Evolut R System with all recapture attempts performed safely with zero strokes (0.0 percent). Additionally, correct valve position with one device was achieved in 98.3 percent of patients, and there were no cases of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve embolization, or conversion to surgery in the study. The pacemaker rate was low at 11.7 percent.
The supra-annular valve design of the CoreValve Evolut R System resulted in low, single-digit mean aortic gradients (a commonly used threshold of exceptional blood flow) at each follow-up visit (9.2mm Hg in early follow-up at 24hrs to 7 days post procedure, and 8.1mmHg at 30-days). The recapturable Evolut R valve features a new extended sealing skirt on the 26 and 29 mm sizes that further promotes valve sealing at the annulus resulting in low rates of paravalvular leak (PVL) with 96.6 percent of patients having < = mild PVL at 30-days with no patients having severe PVL (0.0 percent).
The CoreValve Evolut R System builds off of the successful CoreValve platform, which has been implanted in more than 75,000 patients in more than 60 countries. The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available in Europe and other countries that recognize the CE mark.
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.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.
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.
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