The expected approval comes after a February vote by an FDA panel that confirmed the system’s benefits outweighed its risks.
Abbott designed TriClip to treat tricuspid regurgitation (TR), or a leaky tricuspid valve. Delivered through a vein in the leg, the TriClip TEER technology clips together a portion of leaflets. It repairs the tricuspid valve and helps blood flow in the right direction without the need for open-heart surgery.
TriClip could offer a new option for those who continue to have symptoms or persistent TR despite treatment with medical therapy. It now enters the U.S. TR treatment market that features the Edwards Evoque tricuspid valve. Evoque became the first transcatheter therapy approved to treat TR in February.
While both systems treat TR, Abbott labeled TriClip a first-of-its-kind minimally invasive device. It specifically designed TriClip to treat the difficult-to-access tricuspid valve.
“This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions,” said Sandra Lesenfants, SVP of Abbott’s structural heart business. “With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”
More on the Abbott TriClip TEER system
TR occurs when the tricuspid valve fails to close properly, causing a leak that allows blood to flow backward in the heart. When left untreated, it can lead to AFib, heart failure and potential death.
TriClip represents an option for patients who continue to have symptoms or persistent TR despite treatment with medical therapy. Those patients are not considered good candidates for surgery, but can utilize the minimally invasive TriClip instead. On average, Abbott says those who receive TriClip need just one day in the hospital before recovering and returning home.
According to Abbott, TriClip leverages the same clip-based technology as its leading MitraClip device for mitral regurgitation (MR). However, its unique design specifically addresses the tricuspid valve’s complex anatomy.
The FDA made its decision with support from clinical data from the TRILUMINATE pivotal trial. Abbott most recently reported positive results from that trial at TCT in October. Results included significant improvements in quality of life along with an excellent safety profile. In the study, 90% of TriClip patients experienced a marked improvement in their TR grade. Additionally 98% of patients remained free from major adverse events through 30 days and presented a significant improvement in quality of life.
“The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Dr. Paul Sorajja, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE pivotal trial. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber reacted positively to the approval news, reiterating their “Buy” rating for Abbott.
The analysts note an important detail in that Abbott submitted an application for a new technology add-on payment (NTAP) under the acute inpatient prospective payment system (IPPS) for FY25. Because TriClip received FDA approval before May 1, the analysts say they believe that makes it eligible for the NTAP to go into effect on Oct. 1.
“This is a positive update and we expect TriClip to be gradually adopted over time given the favorable pivotal data, unmet patient need and [Abbott’s] commercial footprint in structural heart solutions.”
The analysts estimate approximately $100 million in revenue from TriClip sales outside the U.S. in fiscal 2023. Already approved in more than 50 countries, TriClip adds to Abbott’s bullishness on the TR opportunity in the U.S. The analysts also note that the similarities to MitraClip mean the benefit of physicians already trained on using similar technology.
They await further updates from Abbott on pricing, commercial rollout and streamlining patient identification.
Medical Design & Outsourcing: How Abbott designed TriClip to repair the ‘forgotten’ tricuspid heart valve
