Cardiac Implants Marks Initial Use of Therapeutic Adjustment Procedure With Tri-Ring Percutaneous Annuloplasty Device

September 14, 2022—Cardiac Implants LLC announced the successful initial deployment of its annuloplasty ring with implementation of a therapeutic adjustment procedure using the company’s Tri-Ring percutaneous annuloplasty device. Cardiac Implants advised it will continue to enroll patients in early feasibility studies to gain additional clinical experience in the treatment of tricuspid regurgitation.

The adjustment procedure is a minimally invasive percutaneous annuloplasty using a two-stage clinical approach. Cardiac Implants’ second-generation Tri-Ring percutaneous annuloplasty device is a complete circular ring implanted from the internal jugular vein in the neck.

Cardiac Implants noted that this clinical case will be highlighted at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

In the press release, the company explained that the Cardiac Implants annuloplasty device allows structural heart interventionalists to percutaneously deliver a complete ring on the tricuspid valve annulus. The adjustment tool allows the operator to reaccess the ring after a short healing period to adjust the ring to the target valve diameter.

The two-stage technique is designed to overcome the risks of implant dehiscence and implant migration seen with other transcatheter approaches and is done without the need for open heart surgery by using a percutaneous delivery approach.

As part of the treatment process, a patient would receive the initial implant of Cardiac Implants’ Tri-Ring device 90 days before the ring adjustment, allowing a healing period between ring implantation and ring adjustment for strong bonds to form between the device and native tricuspid annular tissue.

The device adjustment then reduces the diameter of the ring, decreasing the diameter of the valve annulus and lessening the leakage of the heart valve. The tricuspid valve has little fibrous tissue, making anchoring without a healing interval difficult. The initial device implant procedure takes approximately 90 minutes, and the adjustment procedure approximately 60 minutes.

According to the company, the first procedure was conducted by the structural heart team at NewYork-Presbyterian and Weill Cornell Medicine in New York, New York. The team was led by Mark Reisman, MD, and Stephanie Mick, MD.

“This signifies a paradigm shift in demonstrating the importance of permissive healing of an annuloplasty device placed in the tricuspid annulus,” commented Dr. Reisman in the company’s press release. “The healing period allowed for significant force to be placed on the ring when cinching at the time of the adjustment procedure. The adjustment procedure was performed 90 days after the initial deployment of the device and resulted in a significant reduction in annular area and tricuspid regurgitation.” Dr. Reisman is director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center and recruited as a professor of medicine at Weill Cornell Medicine.

Dr. Mick stated in the press release, “This is an important advance for a problem that is very often too risky to approach surgically. Using the body’s own healing mechanisms to secure the ring is a potential game changer here, because the tricuspid annulus is a delicate and moving structure and challenging to reliably secure without traditional surgical techniques.” Dr. Mick is director of robotic and minimally invasive cardiac surgery at NewYork-Presbyterian/Weill Cornell Medical Center and the Carrie and David Landew Associate Professor of Cardiothoracic Surgery at Weill Cornell Medicine.