FDA Approves Edwards Lifesciences PASCAL Precision System for Tricuspid Valve Repair
The US Food and Drug Administration (FDA) has granted approval to Edwards Lifesciences for its PASCAL Precision transcathedral valve repair system. The medical device is indicated to improve functional status and quality of life in patients experiencing symptomatic severe tricuspid regurgitation (TR) despite receiving optimal medical therapy.
Patient Eligibility and Regulatory Indications
Under the newly cleared indication, eligible candidates are defined as individuals who have been evaluated by a multidisciplinary heart team. These patients must be determined to be appropriate for transcathedral edge-to-edge tricuspid valve repair (T-TEER) and assessed as facing an intermediate or higher surgical risk.
With this regulatory clearance, Edwards Lifesciences stated it is currently the sole manufacturer offering a portfolio of both transcathedral repair and replacement options for both the mitral and tricuspid valves within the United States.
Device Portfolio and Clinical Goals
Daveen Chopra, corporate vice-president of Edwards transcathedral mitral and tricuspid therapies, noted that the PASCAL system has previously served as a treatment option for patients suffering from debilitating symptoms of degenerative mitral regurgitation in the US. The expansion to include tricuspid patients aims to support a broader group of individuals and empower clinicians to select tailored therapies for optimal clinical results.
Alongside the tricuspid indication, the FDA also cleared the PASCAL Ace with Capture Clarity system for degenerative mitral TEER procedures. This particular iteration introduces fluoroscopic indicators designed to help confirm valve leaflet grasping during implantation, aiming to simplify a technically challenging phase of the procedure.
Broader Regulatory Context
Earlier in the month, Edwards secured a separate regulatory milestone when its Autus expandable pulmonary heart valve became the first device of its kind to receive FDA approval for paediatric patients suffering from congenital pulmonary valve disease. Together, these regulatory decisions reflect an ongoing expansion of specialized structural heart device options for patients facing complex cardiovascular conditions.
