|New Study Results Show High Survival Rates and Improved Quality of Life for Patients with Medtronic CoreValve® System|
MINNEAPOLIS –October 22, 2012 – Medtronic, Inc. (NYSE: MDT) today announced new findings from the Medtronic CoreValve ADVANCE Study for 1-year survival and health-related quality of life (HRQoL). The findings were presented this week at Transcatheter Cardiovascular Therapeutics (TCT) Meeting 2012 in Miami.
Initial 1-year results of the ADVANCE Study revealed that patients experienced high survival rates, with 1-year survival at 82.1 percent and 1-year cardiovascular survival at 88.2 percent.
Health-related quality of life (HRQoL) measures for patients in the ADVANCE Study improved significantly at 1 and 6 months, compared with their status prior to receiving the Medtronic CoreValve System. The ADVANCE study represents the largest, most rigorously collected evaluation of HRQoL findings published on transcatheter aortic valve implantation (TAVI).
The CoreValve System is currently limited to investigational use in the United States.
On the SF-12 scale at 6 months, the patients’ health scores significantly improved by 6.92 points from baseline for the physical component summary score (p<0.001), and significantly improved by 3.80 points from baseline for the mental component summary score (p<0.001) (based on the SF-12 scale from 0 to 100 with a higher score reflecting a better HRQoL).
On the EQ-5D scale from 0 (death) to 1 (perfect health), patients’ health scores significantly increased by 0.10 points at both 1 month and 6 months from baseline, (p-value < 0.001). All differences reported are statistically significant.
In the study, even the highest risk patients experienced significant improvements in HRQoL after TAVI: When evaluating these improvements by patient risk, patients with higher risk profiles (EuroSCORE >20) had significantly worse baseline HRQoL than patients with lower risk profiles but still demonstrated significant improvements out to 6 months (EQ-5D p<0.001)).
Additionally, patients who were implanted with the CoreValve System via direct aortic and subclavian access routes demonstrated similar HRQoL improvements, as measured by EQ-5D, as those undergoing transfemoral implantation (the CoreValve System can be implanted via three different delivery routes).
Quality of life was measured at baseline, one month and six months using two general validated questionnaires (the EQ-5D and the SF-12 physical and mental), and health status was self-reported by patients. The ADVANCE study will continue to measure HRQoL benefits over time; one year results will be reported next year.
“Transcatheter aortic valve implantation already has been shown to improve survival compared with standard therapy, but quality of life can be at least as important as survival in elderly patients, especially since TAVI patients can be frail with multiple comorbidities,” said Johan Bosmans, M.D., professor at the University Hospital of Antwerp in Belgium. “We are extremely proud of this data which confirms that the benefits of transcatheter aortic therapy extend beyond survival even in this challenging patient population.”
The ADVANCE study is one of the largest multicenter TAVI trials to date, with 996 patients consecutively treated at 44 experienced TAVI centers in 12 countries. Clinical endpoints were calculated according to Valve Academic Research Consortium (VARC) standardized definitions. All data were independently monitored, all adverse events related to the primary endpoints were adjudicated by an independent Clinical Events Committee (CEC) consisting of experienced cardiac surgeons and interventional cardiologists, 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 (Conformite Europeenne) Mark in 2007, the CoreValve System has been implanted in more than 30,000 patients in more than 60 countries outside of the U.S. 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.
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.
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.
Kathleen Janasz, Public Relations, 763-526-3676
Jeff Warren, Investor Relations, 763-505-2696