|Medtronic CoreValve® System Shows Positive Clinical Outcomes in New Patient Populations|
New Data Show Low Mortality and Improved Quality of Life for Patients with Failed Surgical Aortic Valves, End-Stage Renal Disease and Low Gradient Aortic Stenosis
DUBLIN and SAN FRANCISCO - October 13, 2015 - Medtronic plc (NYSE: MDT) today unveiled new clinical data that showed positive clinical outcomes at one year for the CoreValve System in new patient populations with significant co-morbidities. Results from three patient populations evaluated within the CoreValve® U.S. Expanded Use Study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium in San Francisco.
The three populations included patients with a degenerated surgical bioprosthesis, patients with end-stage renal disease, and patients with low gradient aortic stenosis. While transcatheter aortic valve replacement (TAVR) is not approved for the latter two patient populations, in March, the CoreValve System was the first transcatheter heart valve approved in the U.S. for valve-in-valve procedures in both high and extreme risk patients with failed surgical valves.
"It's encouraging to see patients benefitting from the CoreValve System, many of whom have been unable to receive treatment due to these severe comorbidities," said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center, and chairman of the patient screening committee of the CoreValve U.S. Pivotal Trial. "When treated with the CoreValve system, not only do these patients live longer, they are able to achieve and maintain a good quality of life, which is really important for these individuals and their loved ones."
Patients in the Valve-in-Valve study also experienced a low rate of moderate aortic regurgitation (6.4 percent) with no cases of severe regurgitation (0.0 percent), and benefitted from strong hemodynamic performance with a mean gradient of 16.5mmHg at one year despite placement within small surgical valves.
"In valve-in-valve procedures, the CoreValve system's unique supra-annular design helps maximize blood flow through the aortic valve, which is particularly important when implanting within a surgical valve where the original orifice area is often compromised. TAVR provides physicians with an alternative treatment option for patients facing another open heart surgery," continued Dr. Reardon.
END-STAGE RENAL DISEASE
LOW GRADIENT AORTIC STENOSIS
The CoreValve System is approved by the FDA for patients at extreme risk and high risk for surgery. Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System, and the recently approved CoreValve Evolut R System, has been implanted in more than 80,000 patients in more than 60 countries. To date, the CoreValve system is not FDA approved for patients with end stage renal disease or low gradient aortic stenosis.
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.
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.