- Study data for Abbott's clip-based tricuspid heart valve repair system showed the investigational device reduced tricuspid regurgitation at 30 days, the company said Tuesday. The first-of-its-kind device for tricuspid valve repair builds on Abbott’s MitraClip technology for patients with leaky mitral valves.
- Abbott last month said it had filed for CE mark approval for the system, called the TriClip. The company plans to begin a U.S. pivotal trial in the next few months.
- The late-breaking tricuspid repair data were released at the EuroPCR cardiology meeting in Paris.
Following the success of transcatheter aortic valve replacement (TAVR) as a less-invasive alternative to open heart surgery for patients with diseased aortic valves, medtech companies are stepping up efforts to develop percutaneous approaches to mitral and tricuspid valve repair and replacement.
Edwards Lifesciences is pursuing the mitral and tricuspid markets; in March, the TAVR pioneer announced a deal to acquire certain assets of Mitralign, a company developing a transcatheter annuloplasty system to treat mitral and tricuspid regurgitation.
Tricuspid valve regurgitation is a condition in which the valve between the heart's right ventricle and right atrium doesn't close properly, allowing blood to flow back into the upper right chamber. The condition can lead to heart failure if not treated.
The tricuspid valve is considered difficult to treat. Surgery carries high mortality rates, and there are no approved minimally invasive treatments for patients with moderate or severe tricuspid regurgitation.
Results from Abbott's Triluminate study suggest transcatheter tricuspid valve repair holds potential as a minimally invasive treatment for very ill patients without other options, lead investigator Georg Nickenig, chief of the department of cardiology at University Hospital in Bonn, Germany, said in a statement.
The Triluminate study, conducted at 21 sites in Europe and the United States, is evaluating the safety and performance of Abbott's tricuspid repair device in 85 patients with moderate or greater tricuspid regurgitation who were deemed good candidates for transcatheter intervention. Results at 30 days showed 86.6% of patients saw a reduction in severity of their disease by at least one grade, Abbott said.
In addition, 80.5% of patients were categorized on the New York Heart Association's progressive heart failure classification scale as class I or II at 30 days, compared to 25.6% at baseline, an improvement considered statistically significant. Patients also saw clinically significant improvement in a self-assessment of social abilities, symptoms and quality-of-life. Patients in the study will be evaluated again at six months and one, two and three years, the company said.
The TriClip device build's on Abbott's MitraClip technology for the minimally invasive repair of mitral regurgitation. The MitraClip repairs the valve without open heart surgery and is delivered to the heart through a small incision in the leg. The device clips together the two leaflets of the mitral valve to reduce the backflow of blood, enabling the heart to pump more efficiently.
In March, Abbott received an expanded indication for MitraClip to treat secondary mitral regurgitation, which can develop in heart failure patients when the left chamber of the heart becomes enlarged. The device has been approved in the United States since 2013 to treat primary mitral regurgitation, a structural defect of the valve.