Sam Brusco, Associate Editor04.02.24
Abbott has gained U.S. Food and Drug Administration (FDA) approval for its TriClip transcatheter edge-to-edge repair (TEER) system designed for treating tricuspid regurgitation (TR), or a leaky tricuspid valve.
The approval follows recent recommendation from the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.
The TriClip TEER is delivered through a vein in the leg. It works by clipping together part of the leaflets to repair the tricuspid valve and help blood flow in the right direction without needing open-heart surgery. Abbott said on average, people who get TriClip need one day in the hospital before recovery.
The FDA reviewed findings from the TRILUMINATE pivotal trial to determine its approval. 90% of patients receiving TriClip had a marked improvement in TR grade, reducing from severe or higher to moderate or less at 30 days. The reduction was sustained at one year.
The trial also showed 98% of patients being free from major adverse events through 30 days, as well as a significant improvement in quality of life.
"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, senior VP 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."
TriClip is approved for use in over 50 countries, including Europe and Canada, since initial CE mark approval in 2020. Abbott said the device has been used to treat over 10,000 people with TR.
Last month, Abbott also announced that the initial patient was enrolled in its ENVISION investigational device exemption (IDE) trial for its Navitor transcatheter aortic valve implantation (TAVI) system
The approval follows recent recommendation from the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks.
The TriClip TEER is delivered through a vein in the leg. It works by clipping together part of the leaflets to repair the tricuspid valve and help blood flow in the right direction without needing open-heart surgery. Abbott said on average, people who get TriClip need one day in the hospital before recovery.
The FDA reviewed findings from the TRILUMINATE pivotal trial to determine its approval. 90% of patients receiving TriClip had a marked improvement in TR grade, reducing from severe or higher to moderate or less at 30 days. The reduction was sustained at one year.
The trial also showed 98% of patients being free from major adverse events through 30 days, as well as a significant improvement in quality of life.
"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, senior VP 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."
TriClip is approved for use in over 50 countries, including Europe and Canada, since initial CE mark approval in 2020. Abbott said the device has been used to treat over 10,000 people with TR.
Last month, Abbott also announced that the initial patient was enrolled in its ENVISION investigational device exemption (IDE) trial for its Navitor transcatheter aortic valve implantation (TAVI) system