US-based medical devices firm Abbott has received CE mark approval for its TriClip device to treat (TR) in Europe and other countries that recognize CE Mark.

The TriClip transcatheter tricuspid valve repair system has been approved as a minimally invasive, clip-based tricuspid valve repair device to treat TR, a condition characterised by a leaky tricuspid valve.

Abbott structural heart business senior vice president Michael Dale said: “Tricuspid regurgitation is a highly prevalent, yet seldom treated disease, which is why this approval is a significant milestone for the healthcare community. 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.”

TriClip device is delivered to the heart through the femoral vein in the leg

According to the company, tricuspid valve is referred to as the ‘forgotten heart valve’, and has three leaflets that control the flow of blood between the two chambers on the right side of the heart.

When the leaflets do not close properly, blood can flow in the reverse direction, known as regurgitation, which forces the heart to work harder. TR may lead to atrial fibrillation, heart failure, and ultimately, death, if not treated.

Abbott said that surgical procedures performed using its TriClip, delivered to the heart through the femoral vein in the leg, would repair the tricuspid valve and reduce the backflow of blood, preventing the need for open-heart surgery.

In addition, the CE Mark approval for TriClip is based on the positive six-month data from the TRILUMINATE study, which showed that the device reduced severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.

TRILUMINATE trial lead investigator Georg Nickenig said: “Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options. 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.”

In March, Abbott secured CE Mark approval for the new FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system.

The new FlexNav delivery system is said to provide physicians implanting Portico Valve with improved delivery, flexibility and navigation, even in complex cardiac anatomies.