EuroPCR Presentation of "Real World" ADVANCE Study Confirms Economic Value of Novel Self-Expanding Valve in Patients Unable to Undergo Surgery

PARIS -- May 21, 2013 -- Focused on offering devices that provide both clinical and economic value, Medtronic, Inc. (NYSE: MDT) today unveiled the results of a cost-effectiveness model comparing transcatheter aortic valve implantation (TAVI) with the CoreValve System to medical management. Presented at EuroPCR 2013, the United Kingdom-based analysis compared the "real world" Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study and found that the CoreValve System was cost-effective. Patients participating in this study had severe aortic stenosis and were unable to undergo surgery.

For both treatment pathways the cost-effectiveness model compared the benefits (including life years gained and improvement in quality of life) to lifetime costs (including procedure, device, physician, hospitalizations and other measures) from the perspective of the National Health Service (NHS) in the United Kingdom. Well below many developed countries' cost-effectiveness thresholds, the cost of TAVI with the CoreValve System to gain a year of life was £7,700, and the cost per QALY gained was nearly £11,300.

"With the low mortality and stroke rates, and the overall improvement in quality of life found in the ADVANCE study, TAVI with CoreValve has shown its worth in medical terms. What this study does is benchmark the financial costs: We can now compare the cost-effectiveness of this intervention against other accepted therapies delivered in a national healthcare delivery system. What we find is that despite the high costs of TAVI, it stacks up extremely favorably in terms of QALYs. In short, it is cost effective," concluded Stephen Brecker, M.D., of St. George's Hospital in London and the presenter of the cost-effectiveness data at EuroPCR. "It's gratifying to know that in addition to excellent outcomes, in the current economic climate TAVI with CoreValve represents good value for healthcare spending.

One of the largest and most rigorous TAVI trials to date, the international Medtronic CoreValve ADVANCE Study was conducted with experienced TAVI heart teams across 44 centers in 12 countries. In ADVANCE, clinical endpoints are calculated according to Valve Academic Research Consortium (VARC) standardized definitions. All data were independently monitored, all adverse events related to primary endpoints were adjudicated by an independent Clinical Events Committee (CEC), and all cerebrovascular events (including stroke and other events) were adjudicated by an independent neurologist using neuroimaging and systematic NIH Stroke Scale assessments.

Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System has been implanted in more than 40,000 patients in more than 60 countries. The CoreValve System is available in four valve sizes (23mm, 26mm, 29mm and 31mm), each deliverable via transfemoral, subclavian and direct aortic access through a low-profile, 18Fr delivery catheter. It is not currently approved for commercial use in the United States and is currently undergoing clinical trials in the U.S.

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, Inc. (, headquartered in Minneapolis, is the global leader in medical technology -- alleviating pain, restoring health and extending life for millions of people around the world.