Edwards Lifesciences
(NYSE: EW)
announced today that the FDA granted approval for its Evoque tricuspid valve replacement system.
The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first in Europe and globally.
Edwards can now offer Evoque for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy for whom tricuspid valve replacement is deemed appropriate by a heart team.
“Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease. “We are grateful for the strong collaboration with clinicians all over the world who contributed to the Evoque system now being available through FDA’s breakthrough pathway to provide a treatment option to the many patients in the US suffering with tricuspid valve disease,” said Daveen Chopra, Edwards VP, transcatheter mitral and tricuspid therapies.
More about the Edwards Evoque valve replacement system
Evoque features a nitinol self-expanding frame, intra-annular skirt and tissue leaflets made from bovine pericardial tissue. Edwards intends to offer the valve in three sizes, all delivered through the same low-profile transfemoral 28F system.
Results from the TRISCEND study of Evoque supported the approval. TRISCEND, presented last year, demonstrated favorable safety, efficacy and quality-of-life outcomes. Those outcomes demonstrated high survival of 90.1% and high freedom from heart failure hospitalization at 88.4%. Additionally, subjects showed significant and sustained TR reduction with 97.6% of patients demonstrating mild or trace TR.
Edwards also reported six-month results at TCT 2023, demonstrating favorable safety and effectiveness outcomes. Key findings included significant reduction or elimination of TR and significant and sustained quality of life improvement. Edwards reported a favorable balance between risk and benefit, too.
The company plans to present the full 392-patient cohort’s data from TRISCEND II at TCT 2024.
“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” said Dr. Susheel Kodali, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II study principal investigator. “The Evoque system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients. We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients.”
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber issued a report on the FDA approval that highlighted the importance of the approval. They noted that it came ahead of schedule and without the need for an FDA panel’s judgment. Edwards previously looked toward a mid-year approval after possible advisory committee meeting, they said.
The analysts said the data from TCT proved favorable for Evoque’s ability to drive quality-of-life improvements. They anticipate a “disciplined” U.S. launch by Edwards.
Additionally, they say the approval may “invite comparisons” to Abbott’s TriClip G4, a tricuspid valve edge-to-edge repair (TEER) system. It’s intended for the treatment of symptomatic severe TR.
The FDA plans to discuss premarket approval for TriClip G4 in a panel on Feb 13 and the analysts noted confusion over why that required a panel review but Evoque didn’t. They still expect approval for TriClip G4 regardless of the panel.
Despite the good news for Edwards, the analysts maintained their “Neutral” rating for the company.