FDA approved the Edwards Lifesciences Pascal Precision system for tricuspid valve repair. Edwards announced it on October 21. The label covers symptomatic severe tricuspid regurgitation in patients who stay symptomatic on optimal medical therapy and carry intermediate or greater surgical risk, with a multidisciplinary heart team signing off on the approach.
Pascal Precision already held an approval in degenerative mitral regurgitation. Edwards took a second authorization the same day for Pascal Ace with Capture Clarity in degenerative mitral TEER. That system adds fluoroscopic indicators showing when the leaflets have been grasped, which Edwards says no other approved TEER device offers.
Edwards now sells transcatheter repair and replacement devices for both the mitral and tricuspid valves, with Evoque covering tricuspid replacement. Abbott sells TriClip for tricuspid repair and has no FDA approved tricuspid replacement. Leerink Partners said the approval strengthens Edwards in a tricuspid market it called large and underpenetrated.