Abbott’s next-generation device for tricuspid heart valve repair gains CE mark approval
Abbott announced Friday, April 8, that the company has gained CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system, which was designed specifically to treat patients with tricuspid regurgitation.
Abbott said this is the first solution of its kind to hit the European market, pointing to how many ways the clip-based treatment—known as TriClip G4—can be customized to meet the needs of each patient.
“Tricuspid regurgitation is considered the most undertreated valve issue and our newest generation device to address it is the result of our unwavering commitment to restore health and improve the quality of life for patients with structural heart disease,” Mike Dale, senior vice president of Abbott's structural heart business, said in a prepared statement. “Our novel TriClip therapy offers the best possible outcomes for people suffering from a debilitating condition and gives doctors even more options for customizing repair of this complex anatomy.”
“Since its initial CE mark in April 2020, TriClip has emerged as a much-needed treatment option, offering physicians the opportunity to dramatically improve the quality of life for people in Europe with severe, symptomatic tricuspid regurgitation who are not responding to medical therapy and are often so ill they cannot undergo surgery,” added Philipp Lurz, MD, PhD, professor and deputy head of cardiology at Heart Center Leipzig in Germany. “This newest generation device further improves cardiologists' ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat.”
TriClip is only approved in the United States for investigational use at this time.
Abbott’s announcement came just days after its Xience stent received CE mark approval for treating patients at a high risk of bleeding with short-term dual anti-platelet therapy (DAPT) after the procedure.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.