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Cardiac Implants Announces Successful Therapeutic Adjustment Procedure Using Tri-Ring™ Percutaneous Annuloplasty Device

Thursday, September 15, 2022

Cardiac Implants LLC has achieved a significant milestone with the successful initial deployment of its Annuloplasty ring and the implementation of a therapeutic adjustment procedure using its innovative Tri-Ring™ percutaneous annuloplasty device.

The procedure was performed by the esteemed structural heart team at NewYork-Presbyterian and Weill Cornell Medicine, led by Dr. Mark Reisman, director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center, and Dr. Stephanie Mick, director of robotic and minimally invasive cardiac surgery at NewYork-Presbyterian/Weill Cornell Medical Center. The procedure represents the first minimally invasive percutaneous annuloplasty in the United States using a two-stage clinical approach. It involved the utilization of Cardiac Implants' second-generation Tri-Ring™ percutaneous annuloplasty device, which is a complete circular ring implanted from the internal jugular vein in the neck.

Dr. Reisman commented, "This signifies a paradigm shift in demonstrating the importance of permissive healing of an annuloplasty device placed in the tricuspid annulus. 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. Mick emphasized the significance of this advancement, stating, "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."

The process involves the initial implantation of Cardiac Implants' Tri-Ring™ device in a patient 90 days prior to the ring adjustment, allowing ample time for strong bonds to form between the device and the native tricuspid annular tissue. The subsequent adjustment procedure reduces the diameter of the ring, thereby decreasing the diameter of the valve annulus and reducing the leakage of the heart valve. The tricuspid valve's lack of fibrous tissue makes anchoring without a healing interval challenging. The initial device implant procedure takes approximately 90 minutes, while the adjustment procedure takes approximately 60 minutes.

Tricuspid regurgitation (TR) is a condition with complex pathophysiology and, if left untreated, can lead to long-term adverse consequences. In the United States, an estimated 1.6 million people suffer from TR. Left untreated, TR can progress to chronic heart failure, which is a leading cause of hospitalization in the United States and Europe. Despite the prevalence of TR, there are limited procedural treatment options available for this complex patient population.

Dr. Mark Turco, CEO of Cardiac Implants, expressed enthusiasm for their percutaneous annuloplasty approach, stating, "We believe that our percutaneous annuloplasty approach is a breakthrough in the treatment of TR. It is a less invasive alternative to surgery and fulfills the huge unmet medical need for this disease population with treatment aimed at the specific pathophysiology of the tricuspid valve. We are very excited to see the potential for the performance of the Tri-Ring Annuloplasty Device."

The Cardiac Implants' annuloplasty device allows structural heart interventionalists to deliver a complete ring on the tricuspid valve annulus through a percutaneous approach. The adjustment tool enables re-access to the ring after a short healing period, facilitating adjustments to the target valve diameter. This two-stage technique addresses the risks associated with implant dehiscence and migration seen with other transcatheter approaches, eliminating the need for open

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