Edwards Lifesciences Corporation has launched its new, patented Tricentrix holder system for use with the Carpentier-Edwards Perimount Plus mitral pericardial valve in the U.S. The system, which is used to hold and position the replacement valve during mitral heart valve surgery, makes it easier to implant the world-leading Perimount mitral tissue valve.
The development will enable Edwards to build upon the Perimount valve's widespread clinical acceptance, based on its proven superior durability over porcine tissue valves and lower risks associated with bleeding or other complications as compared to mechanical valves.
"The Perimount mitral valve's excellent, long-term clinical performance as compared to alternative valve technologies, combined with the unique design features of the Tricentrix holder, will provide real benefits for more patients as surgeons realize the ease with which this valve can be implanted," said Anita B. Bessler, Edwards' corporate vice president of Global Franchise Management. "This is an important development for Edwards, as we believe it will make it much easier for surgeons to recommend the Perimount mitral valve to their patients."
The Tricentrix holder system has been successfully used in several U.S. cases over the past few weeks. "Our experience with this holder system has demonstrated improved ease of implantation, regardless of a surgeon's preferred technique," said Dr. Delos M. Cosgrove, chairman of the Department of Thoracic and Cardiovascular Surgery at The Cleveland Clinic Foundation.
Edwards' Tricentrix holder's unique design was the result of a year-long collaboration between leading surgeons, Edwards' innovative engineering team, and the award-winning ergonomics design firm IDEO, based in Palo Alto, California. The holder's ultra-low profile design creates better visualization and operating space for the surgeon by allowing the valve to quickly and easily "parachute" into the precise opening of the patient's native valve. The holder offers one-piece removal and a quick-release handle, providing efficiencies that can help decrease operating time.
Patients with mitral valve problems often suffer from degenerative heart valve disease, in many cases leaving a patient's native valve too damaged to permit repair and making replacement surgery the only option. The Perimount Mitral Pericardial heart valve is the first and only biomechanically engineered tissue heart valve that is designed specifically to meet the challenges and high pressures required for the mitral position. It provides patients with the most durable tissue alternative, as well as enhanced quality of life without the clicking noises or requirements for anticoagulation medication and dietary restrictions commonly associated with mechanical valves.