Minneapolis health giant Medtronic (NYSE:MDT) unveiled new findings from its CoreValve Advance study, showing a 1-year survival rate of 82.1% and improved health-rated quality of life at 1 and 6 months.
Medtronic’s CoreValve device is a self-expanding heart valve prosthetic that can be delivered via catheter rather than through surgery.
The Advance study included 996 patients across 44 TAVI centers in 12 countries, finding quality of life improvements among even the highest-risk patients, according to the company.
Quality of life was measured at baseline, 1 month and 6 months. The study will continue to measure HRQoL benefits over time and 1 year results will be reported next year, according to the press release.
“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 co-morbidities,” said Dr. Johan Bosmans, 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.”
More than 30,000 patients in more than 60 countries outside of the U.S. have received the CoreValve System, Medtronic said. The system is available in 4 valve sizes.
Medtronic CoreValve system received CE Mark approval in European markets in 2007. It is still not available for sale in the U.S., where Edwards Lifesciences (NYSE:EW) maintains the lead, with its Sapien device being the only FDA-approved TAVI system available.
Late last week Edwards announced that it won expanded indication from the FDA to treat lower-risk patients with its Sapien TAVI system.
The federal watchdog agency approved Sapien for use in patients who are eligible for surgery but who are "at high risk for serious surgical complications or death," according to the FDA notice.
Medtronic: Positive results of 2 year trial for Symplicity renal denervation
Medtronic’s Symplicity HTN-1 clinical trial, which investigates the safety and efficacy of renal denervation in patients with treatment-resistant hypertension, found that patients experienced a mean blood pressure reduction at 24 months when they received renal denervation treatment with the Symplicity system.
The Symplicity renal denervation system is not yet approved by the FDA for commercial distribution in the U.S., though the system has been used for 5 years to treat thousands of patients with treatment-resistant hypertension worldwide. The device is on the market in parts of parts of Europe, Asia, Africa, Australia and the Americas, according to the press release.
Medtronic: Cutting anti-platelet therapy doesn’t increase thrombosis risk in Resolute DES patients
New 1-year analyses of results from Medtronic’s Resolute clinical trials
concluded that patients implanted with the company’s Resolute drug-eluting stent showed no increased rates of stent thrombosis when interrupting dual anti-platelet therapy after 30 days following stenting.
The analysis of dual anti-platelet therapy interruption included data on nearly 5,000 patients from 250 sites in 21 countries.