The latest update from Medtronic’s (NYSE:MDT) ADVANCE registry of patients treated with the CoreValve transcatheter aortic valve implantation evaluated the technology from a cost perspective, with researchers reporting that CoreValve is worth the money for patients with severe aortic stenosis.
The study was the 1st of its kind assessing cost-effectiveness data, finding that the CoreValve system is a reasonable alternative to medical management for "real world" patients.
"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," study presenter Dr. Stephen Brecker said in prepared remarks on behalf of the company. "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," he added. "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."
The ADVANCE study includes TAVI teams from 44 centers in 12 countries, with all data independently monitored and all adverse events related to primary endpoints adjudicated by an independent committee.
The CoreValve technology has been on the European market since 2007, when it was the 1st TAVI system approved by EU regulators. CoreValve has yet to make it to the shelves in the U.S., where the company has repeatedly called it a “2014 product.”
TAVI arch-rival Edwards Lifesciences (NYSE:EW) won U.S. approval for its Sapien TAVI system in 2011.
1-year results
In a separate analyses of ADVANCE study data, researchers reported that the CoreValve system is still on track with low mortality and stroke rates at 1 year following treatment. Moderate valve leakage, or aortic regurgitation, was present in 13% of patients, still a nagging concern with replacement valve technology.
Researchers reported a 21.2% rate of all-cause mortality, myocardial infarction, emergent surgery or percutaneous re-intervention, the study’s primary endpoint, heartwire reported.
