Abbott to trial tricuspid repair device, with eyes on CE mark

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With this trial, Abbott expects to support a CE mark application for its transcatheter, clip-based treatment for tricuspid regurgitation.

Abbott has enrolled the first patient in a clinical study to investigate its minimally invasive, clip-based system as a treatment for leaky tricuspid valves.

In people with tricuspid regurgitation, blood leaks backward through the tricuspid valve every time the heart’s right ventricle contracts. Some patients who have milder symptoms may not need treatment, but those with severe regurgitation require surgical valve repair or replacement to avoid complications. These include atrial fibrillation and heart failure.

The transcatheter tricuspid valve repair (TTVR) system to be tested is based on Abbott’s MitraClip system, which repairs leaky mitral valves. There is currently no approved minimally invasive treatment for moderate to severe tricuspid regurgitation.

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"Current pharmacological and surgical treatment options are not meeting the needs of people living with tricuspid regurgitation," said Georg Nickenig, M.D., Ph.D., a professor and chief of the department of cardiology and University Hospital, Bonn, in a statement. Nickenig is the lead investigator of the study. "Abbott's MitraClip has shown positive results for mitral regurgitation, and we hope this study shows that a similar clip-based technology may effectively treat people with tricuspid regurgitation."

Abbott expects the trial, dubbed TRILUMINATE, to support a CE mark application for a clip-based TTVR system. The prospective, single-arm study will take place at 25 sites in the U.S. and Europe and will evaluate the performance of the clip-based device in 75 patients. The investigators will measure reduction in tricuspid regurgitation at 30 days and the adverse event rate at 6 months.

Galway, Ireland-based 4Tech is working on its own TTVR system, raising $29 million in its series B round last year to propel its device toward a CE mark. Soon after, Mitralign picked up nearly $40 million, earmarked to get its TTVR through U.S. and EU approval and launch.