FDA approves Pascal Precision system from Edwards Lifesciences for tricuspid valve repair
Edwards Lifesciences has received U.S. Food and Drug Administration (FDA) approval for its Pascal Precision system to be used for tricuspid valve repair procedures. The device is now indicated for improving a patient’s quality of life and functional status if they present with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy. The treatment must also be deemed appropriate by a multidisciplinary heart team.
In 2022, the FDA approved the Pascal Precision system for transcatheter mitral valve repair. This update means the device is now approved for both mitral transcatheter edge-to-edge repair (M-TEER) and tricuspid transcatheter edge-to-edge repair (T-TEER) procedures.
“The Pascal system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the U.S. for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the U.S.,” Daveen Chopra, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, said in a prepared statement. “With the addition of the Pascal tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal clinical results.”
Image courtesy of Edwards Lifesciences.
Edwards Lifesciences receives additional approval for its Pascal technology
In addition, the Pascal Ace with Capture Clarity system from Edwards has been approved by the FDA for degenerative M-TEER procedures. The Pascal Ace with Capture Clarity system includes fluoroscopic indicators that confirm when the valve’s leaflets have been grasped during the implant procedure.
“Building on the Pascal system’s intuitive design, the Capture Clarity indicators provide a novel and easy way of confirming leaflet capture, which is critical and can be challenging,” Santiago Garcia, MD, director of the structural heart program with The Christ Hospital Health Network, said in the same statement. “This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.