Cardiac Implants has announced the successful initial deployment of its annuloplasty ring with implementation of a therapeutic adjustment procedure using its Tri-Ring percutaneous annuloplasty device.
The procedure was conducted by the structural heart team at NewYork-Presbyterian and Weill Cornell Medicine (New York, USA), led by Mark Reisman and Stephanie Mick. The adjustment procedure represents the first minimally invasive percutaneous annuloplasty in the USA using a two-stage clinical approach and utilised Cardiac Implants’ second-generation Tri-Ring percutaneous annuloplasty device, a complete circular ring implanted from the internal jugular vein in the neck, the company said in a press release.
“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,” commented Reisman.
“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,” said Mick.
As part of the process, a patient would receive the initial implant of Cardiac Implants’ Tri-Ring device 90 days prior to 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. Unlike other valves, 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.
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 re-access 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. Cardiac Implants will continue to enrol in early feasibility studies to gain additional clinical experience.