WASHINGTON (dpa-AFX) - Edwards Lifesciences (EW) announced that the U.S. FDA has approved the PASCAL Precision System for tricuspid valve repair, providing a new treatment option for certain patients with severe tricuspid regurgitation.
The approval expands Edwards' portfolio of minimally invasive heart valve therapies.
Tricuspid regurgitation (TR) is a condition in which the heart's tricuspid valve does not close properly, allowing blood to flow backward within the heart. The condition can lead to symptoms such as fatigue, swelling, shortness of breath, and reduced quality of life. Patients with severe disease are often older and may face elevated risks from open-heart surgery.
The FDA approved the PASCAL Precision System for patients with symptomatic severe tricuspid regurgitation who continue to experience symptoms despite optimal medical therapy and are considered at intermediate or greater surgical risk. The system is used in a minimally invasive transcatheter edge-to-edge tricuspid valve repair (T-TEER) procedure, allowing physicians to repair the valve without open-heart surgery.
According to Edwards, the approval makes it the only company in the United States offering both repair and replacement transcatheter therapies for the mitral and tricuspid heart valves.
In a separate regulatory decision, the FDA also approved the PASCAL Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair procedures. The device includes fluoroscopic indicators designed to help physicians confirm successful leaflet capture during the procedure, a key step in valve repair.
The company said one-year results from the pivotal CLASP IITR trial evaluating the PASCAL tricuspid system will be presented during late-breaking sessions at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting.
The approval further expands Edwards' structural heart portfolio as the company continues to focus on minimally invasive therapies for patients with valve disease who may not be suitable candidates for traditional surgery.
EW has traded between $74.66 and $96.29 over the past year. The stock is currently trading at $88.90, up 0.73%.
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