The physician selection committee and the core imaging lab will determine the optimal route for delivery of the GATE™ AVS. An animation of trans-jugular delivery and an image of trans-atrial delivery are shown below.
There is an on-going effort to develop a trans-femoral delivery system.
Trans-jugular Approach: Animation
Trans-atrial Approach: Image
GATE™ System Overview
Ventricular View (ØRV)
The GATE™ System is intended to treat functional tricuspid regurgitation (FTR)/tricuspid insufficiency by replacing the function of a patient’s dysfunctional native tricuspid valve with a bio-prosthetic atrioventricular valved stent (AVS). The AVS is designed to restore valve function in patients presenting with FTR/tricuspid insufficiency without the need for conventional, open-heart surgery.
The GATE™ System is comprised of an Atrioventricular Valved Stent (AVS), delivery catheter and related accessories. The AVS is being developed in a range of sizes, including Ø40mm, Ø44mm, Ø48mm, and Ø52mm, with a maximum profile height of 23mm.
Atrial View (ØRA)
The AVS is of tri-leaflet design and includes patented partially dehydrated tissue technology, a self-expanding Nitinol stent and special fabric to encourage fibrous ingrowth of biological material to aid in inter-chamber sealing of the device. The design of the AVS is intended to capture the native annulus and leaflets of the dysfunctional tricuspid valve.