In an interview with PharmaShots, Neil Moat, M.D., Chief Medical Officer of Abbott's Structural Heart Business shares his views on the CE mark approval of first-of-its-kind TriClip device.

Shots:

• The new iteration of the device, called TriClip G4, offers new clip sizes and an enhanced leaflet grasping feature for physicians to further customize treatment to the complex tricuspid valve and each patient's unique anatomy
• In tandem with this approval, TriClip G4 also recently received Health Canada authorization, broadening its access to more people with TR across the world.
• Tricuspid regurgitation is a condition in which the valve between the two right heart chambers doesn't close properly, resulting in a backflow of blood into the right atrium of the heart

Tuba: Discuss the key features of the next-generation TriClip Transcatheter Tricuspid Valve Repair System.

Neil:  Our TriClipG4 device is the latest innovation within our leading transcatheter portfolio, and allows for minimally invasive repair of the heart's tricuspid valve. The technology builds upon our original TriClip device, which utilized a delivery system designed specifically for the tricuspid valve and allowed cardiologists to safely treat patients with tricuspid regurgitation (TR). New to this next-generation device is an enhanced leaflet grasping feature which allows physicians to independently grasp and effectively clip leaflets of the tricuspid valve during the procedure. Two additional clip sizes are also available, offering clinicians a total of four sizes to tailor treatment to each patient's unique anatomy.

Source: Abbott

Tuba:  What does this CE mark mean to the company and the patients with tricuspid regurgitation?

Neil:   This CE Mark broadens access to TriClip G4 to more people with tricuspid regurgitation across the world. TriClip G4 provides a non-surgical therapy for addressing tricuspid regurgitation, a condition that has had historically limited treatment options.  

Tricuspid regurgitation typically impacts older individuals who have multiple co-morbidities, making open-heart surgery a high-risk procedure and resulting in many people going untreated. When individuals don't address their tricuspid regurgitation, they often develop other serious conditions such as atrial fibrillation and heart failure that may ultimately become fatal. Patients with severe tricuspid regurgitation typically have very unpleasant and debilitating symptoms that often do not respond well to medical therapy. With the minimally invasive TriClip G4 therapy, doctors can repair a patient's tricuspid valve quickly and dependably, so that patients can get back to living a healthier and better quality of life without undergoing surgery.  

Tuba: What is Tricuspid Valve Regurgitation? What are its symptoms, diagnosis, and epidemiology?

Neil:   Tricuspid regurgitation is a condition in which the valve between the two right heart chambers doesn't close properly, resulting in a backflow of blood into the right atrium of the heart. Since there aren't often warning signs of tricuspid regurgitation like fatigue, shortness of breath, and abnormal heart rhythms until the condition is severe, it's often underdiagnosed or diagnosed incidentally when tests are conducted for other conditions.

Tuba: Discuss the clinical data supporting the CE mark of TriClip G4.

Neil:  Recent data from Abbott's TRILUMINATE CE Mark study for TriClip showed sustained improvement of symptoms, reduced severity of tricuspid regurgitation and improvement in functional status. These results demonstrate the benefits of the therapy and show that it is a safe and durable treatment option for high-risk patients with symptomatic moderate or greater tricuspid regurgitation.

Tuba:  Can we have a glance at the working and the design of TriClip G4?  

Neil:  The TriClip G4 therapy 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.

TriClip G4 leverages the technology and robust body of evidence from our leading MitraClip device, which is a minimally invasive option to repair leaky mitral valves (mitral regurgitation). However, TriClip is specifically designed for the tricuspid valve's complex anatomy and has a specialized delivery system engineered for navigating the right side of the heart.

With the therapy, there is now, for the first time, a reliable treatment option for incredibly ill patients who are very often too sick or frail to undergo traditional surgery to fix their TR.

Tuba: How this newest generation device better than the previous generation of the device?

Neil:  We, at Abbott, are always committed to continuously innovating our portfolio of transcatheter valve therapies to address debilitating heart conditions. The next-generation TriClip device has an enhanced leaflet grasping feature that helps physicians to deliver the device more effectively to the heart, and additional clip sizes that make treatment more customizable to different or more challenging patient anatomies.

Tuba: How TriClip TTVr is an innovative treatment alternative for patients who are at high risk of surgery?

Neil:  Traditionally, the only treatment options for tricuspid regurgitation have been surgery, which is rarely performed due to the complexity of the procedure and the high risks involved. Medical therapy primarily addresses symptoms but does not offer a long-term solution or address the underlying cause of the disease.

Since TriClip's initial CE Mark last year, the device has offered a safe, minimally invasive option for treating tricuspid regurgitation in patients who are not responding to medical therapy or who are not candidates for surgery. The TriClip procedure improves the quality of life for people with this condition, without the potential complications associated with open-heart surgery.

Image Source: Hospimedica

About Neil Moat:

Neil Moat is the Divisional VP & Chief Medical Officer of Abbott's Structural Heart Business. He has a Master's degree from London University.

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