Abbott (NYSE:ABT) announced today that its TriClip transcatheter tricuspid valve repair system won CE Mark approval in Europe.
Abbott designed TriClip for people with a leaky tricuspid valve, otherwise known as tricuspid regurgitation (TR). The company touts it as the first minimally invasive, clip-based tricuspid valve repair device in the world to be made commercially available.
When untreated, TR can lead to atrial fibrillation, heart failure and death, and it typically occurs in older patients with multiple co-morbidities, making open-heart surgery a high-risk procedure. The TriClip repairs the tricuspid valve without the need for open-heart surgery.
Health providers deliver the device through the femoral vein in the leg to the heart, where it clips together a portion of tricuspid valve leaflets to reduce the backflow of blood, allowing the heart to pump more efficiently.
“Tricuspid regurgitation is a highly prevalent, yet seldom treated disease, which is why this approval is a significant milestone for the healthcare community,” Abbott structural heart business senior VP Michael Dale said in the release. “TriClip has the potential to fill a treatment gap and transform how doctors are able to help people with tricuspid regurgitation.
“Our clip-based technology provides clinicians a life-changing, proven safe, simple, and effective option to treat people suffering from a crippling and life-threatening disease.”
Abbott said in a news release that its CE Mark approval comes on the back of positive six-month data from the pivotal Triluminate study examining edge-to-edge repair using TriClip. The study showed that the device reduced the severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.
“Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options,” University Hospital, Bonn, Germany, chief of the department of cardiology and lead investigator on the Triluminate trial Dr. Georg Nickenig said. “Abbott’s TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life.”
