Hoag Memorial Hospital Presbyterian is participating in a study with the newest heart valves from Irvine’s Edwards Lifesciences Corp. (NYSE: EW), Orange County’s most valuable publicly traded company, with a valuation topping $50 billion as of last week.
The study, called Momentis, will follow patients over a 10-year period after they receive an Edwards Mitris Resilia valve.
Since the valve last year received Food and Drug Administration approval, Hoag has already performed more than a dozen mitral valve replacements in the last eight months.
“It’s a good valve,” Dr. Anthony Caffarelli, director of Cardiothoracic Surgery at Hoag and principal investigator for the study, told the Business Journal. “This newer substrate of valve is going to win.”
Newport Beach-based Hoag, Orange County’s second largest hospital, is recruiting patients for a long-term study designed to collect real-world clinical outcomes.
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute is one of the first sites enrolling patients into the trial with plans to expand trial locations globally.
Edwards has developed technology that it calls Resilia, which is a bovine pericardial tissue treated with advanced anti-calcification technology and serves as the platform for Edwards’ newest valves.
Edwards touts the Resilia tissue for providing enhanced calcium blocking properties and dry tissue packaging conditions that facilitate ease of use.
Excess calcium is one of the primary causes of reintervention following heart valve replacement, Edwards said. The tissue has demonstrated freedom from structural valve deterioration at five years, Edwards said.
The Resilia technology initially was used on aortic valves.
“Resilia processing has been put on aortic valves and that data looks good,” Caffarelli said.
Edwards’ Mitris Resilia valve is a tissue valve replacement specifically designed for the heart’s mitral position.
The mitral valve, which is one of the heart’s four valves, often deteriorates faster than other valves because it separates low blood pressure flows from high blood pressure, which puts it under considerable pressure, Caffarelli said.
Mitral valve disease, which affects more than 8 million Americans, can cause obstruction (stenosis), leakage (regurgitation), or a combination of both.
About 90% of mitral surgeries at Hoag are to repair the problem, Caffarelli said, adding that sometimes when there is too much calcium, the valve must be replaced.
The Mitris Resilia valve is now commercially available in both the U.S. and Japan.
The Mitris Resilia mitral valve “features our Resilia tissue technology for extended durability and decreased calcification, which is a key factor in structural valve deterioration,” said Jennifer Currin, senior vice president, Medical and Clinical Affairs, Surgical Structural Heart at Edwards.
“Our Mitris Resilia valve gives surgeons the freedom to offer a resilient alternative that brings the quality-of-life benefits of tissue valves to their patients.”