April 9, 2020 — Abbott announced its TriClip Transcatheter Tricuspid Valve Repair (TTVR) System has received European CE mark clearance as a non-surgical treatment for people with a tricuspid valve regurgitation (TR).
The device is an iteration of the of Abbott's highly successful MitraClip used for transcatheter mitral valve repair (TMVR). It is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available in the world. It is the second tricuspid valve repair device cleared for use in Europe, following the 2018 approval of the Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System.
The TriClip procedure repairs the tricuspid valve without the need for open-heart surgery. The device is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. This approach allows the heart to pump blood more efficiently, relieving symptoms of TR and improving a person's quality of life.
"Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options," said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the TRILUMINATE trial, which generated strong data that helped lead to the CE mark of TriClip. "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."
The CE mark for TriClip follows positive six-month data from Abbott's pivotal TRILUMINATE study examining edge-to-edge repair technique using TriClip, which was published in The Lancet in November 2019. The study demonstrated that TriClip reduced severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.
TriClip builds upon the proven success of Abbott's MitraClip device, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip leverages the same clip-based technology as MitraClip but has a differentiated delivery system designed specifically for delivery to the tricuspid valve. A new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.
The MitraClip system is the first transcatheter mitral valve therapy with more than 16 years of clinical experience and proven safety, survival and durable clinical outcomes. More than 100,000 patients have been treated worldwide with the device.
About Tricuspid Valve Regurgitation
The tricuspid valve, often referred to as the "forgotten heart valve," has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder. When left untreated, TR can lead to conditions such as atrial fibrillation, heart failure, and ultimately, death. The condition is difficult to treat, however, and options for patients have historically been extremely limited. People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.
The European approval comes on the heals of CE mark in January for the Tendyne for mitral valve replacement, the first commercially approved transcatheter mitral valve in the world. Read the article World's First Transcatheter Mitral Valve Approved in Europe.
For U.S. important safety information on MitraClip, visit: https://www.structuralheartsolutions.com/us/mitraclip-isi.
The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device only in the U.S.
The Tendyne Transcatheter Mitral Valve Implantation System is an investigational device only in the U.S.
Related Transcatheter Tricuspid Valve Repair Content:
VIDEO: Tricuspid Device Clinical Trial Overview — Interview with Ori Ben-Yehuda, M.D.
VIDEO: Tricuspid Valve Imaging and Interventions Developing Hand-in-hand — Interview with Rebecca Hahn, M.D.,
1. Georg Nickenig, Marcel Weber, Philipp Lurz, et al. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. The Lancet. Vol 394, issue 10213, P2002-2011, Nov 30, 2019. DOI:https://doi.org/10.1016/S0140-6736(19)32600-5.