Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available.

The Triclip 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.

Robert Ford, Abbott’s president and COO, discussed the device during the company’s fourth-quarter earnings call Jan. 22. “Triclip, this is a modified version of our Mitraclip to treat the leaky heart valve. We believe it's a big opportunity because therapy – if mitral therapy is low, tricuspid leaky valve treatment or repair is even lower. ... [W]e know how to build this. We did it with mitral, and we're going to go about doing it the same way, building the capabilities, the clinical evidence,” he added.

Triclip uses the same clip-based technology as Mitraclip; however, its delivery system is designed specifically for the tricuspid valve. A steerable guiding catheter system adapts to the right side of the heart, enabling the physician to grasp and clip the leaflets of the tricuspid valve. It also is available in two sizes – NT and XT – to accommodate different patient anatomies.

“We have planned for a controlled roll-out to ensure the highest levels of technical success, patient safety and the same positive outcomes we’ve experienced in the clinical trial setting,” an Abbott spokesperson told BioWorld. She added that the pivotal trial in the U.S., known as TRILUMINATE, is moving forward and is well underway. It is aiming to help the company better understand which patient populations could benefit from the therapy.

“People with leaky tricuspid valves in the U.S. currently have few treatment options, and our TRILUMINATE pivotal study, if successful, could potentially provide them with a new, minimally invasive therapeutic option,” the spokesperson continued. “CE mark approval of Triclip is an important first step towards U.S. approval.”

The win with Triclip follows positive six-month data from the TRILUMINATE study examining an edge-to-edge repair technique using the device that 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.

Last fall also saw a discussion of Triclip at the Transcatheter Cardiovascular Therapeutics 2019 conference. After six months, the TRILUMINATE feasibility study showed patients who received the device experienced a reduction of TR. Specifically, 87% of patients had a reduction in their TR at six months. They also saw quality of life improvements, including better Kansas City Cardiomyopathy Questionnaire scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output.

In a March 20 note, William Blair’s Margaret Kaczor wrote about companies in the cardiovascular space and their exposure to COVID-19. She noted that Abbott, Edwards Lifesciences Corp. and Medtronic plc are best positioned.

“Abbott is the most diversified player (geographically and product portfolio-wise) with a low debt ratio and a 1.9% dividend yield. Though there will inevitably be a mix of business that will see headwinds, they also could see tailwinds,” she wrote.

Others in the space

Abbott’s win comes shortly after Cardiovalve Ltd., of Or Yehuda, Israel, won a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in TR.

The company’s offering is designed to be a transfemoral venous access system with a transseptal approach and will aim to replace the mitral or tricuspid valve via a minimally invasive procedure. The company has three valve sizes – M, L and XL – covering about 90% of prospective patients.

For its part, Croívalve, a Dublin-based startup supported by Enterprise Ireland that is developing a treatment for TR, scooped up funding last fall to accelerate the development of the company's technology into first-in-human studies.

On March 23, the company revealed the successful first human use of its Duo Tricuspid Coaption Valve technology for tricuspid repair. The procedure was approved by Ireland’s Health Products Regulatory Authority under its compassionate use program.

Finally, Edwards Lifesciences Corp., of Irvine, Calif., also is in the space. “We have initiated enrollment in our CLASP IITR pivotal trial to study Pascal in patients with symptomatic, severe tricuspid regurgitation” CEO Mike Mussallem said during the company’s Jan. 30 earnings call. "[W]e made meaningful progress on our Evoque tricuspid replacement program. And in addition, we're continuing to gain experience with our Cardioband tricuspid system in select sites as we develop our next-generation technology.”

According to the Mayo Clinic, physicians typically go with heart valve repair first because of a lower risk of infection. However, not all valves can be repaired.