The US Food and Drug Administration (FDA) has approved Edwards Lifesciences’ tricuspid valve repair system, PASCAL Precision.
The transcatheter medical device is indicated to improve functional status and quality of life in patients experiencing symptomatic severe tricuspid regurgitation (TR) despite the administration of optimal medical therapy.
Under the cleared indication, eligible candidates are those evaluated by a multidisciplinary heart team, determined to be appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER), and assessed as facing an intermediate or higher surgical risk.
Edwards stated that, following this regulatory decision, it is the sole manufacturer offering a portfolio of transcatheter repair and replacement options for both mitral and tricuspid valves in the US.
Edwards transcatheter mitral and tricuspid therapies corporate vice-president Daveen Chopra said: “The PASCAL system has been a valuable option for treating patients suffering from debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US.
“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.”
Alongside the tricuspid indication, the FDA cleared the PASCAL Ace with Capture Clarity system for degenerative mitral TEER (M-TEER) procedures.
The device represents the first FDA-approved TEER system incorporating fluoroscopic indicators to confirm valve leaflet grasping during implantation.
According to Edwards, the visual indicators address a technically difficult phase of TEER procedures and help simplify procedural complexity.
Earlier this month, Edwards’ Autus expandable pulmonary heart valve became the first device of its kind to receive FDA approval for paediatric patients with congenital pulmonary valve disease.
