In many commercial TAVI systems, the catheter must be delivered through an external introducer sheath, which typically has an outer diameter (OD) of at least 21F (labeled as 18F inner diameter, or ID). Therefore, the size of the delivery system is actually determined by the sheath, rather than by the catheter, and is at least 21F. A delivery system with a smaller OD is desirable, however if it is too small, the structural integrity (i.e. durability) of the TAV may be compromised.
The Company has now developed an 18F catheter delivery system, with built-in sheath, for Optimum TAV that uses the new technology of a built-in sheath. The Company had previously developed a similar 22F catheter that was successfully used to implant Optimum TAV in 10 sheep and 1 pig.
The Company’s new delivery system is comparable to many TAVI systems on the market.
Optimum TAV’s catheter is also unique because it can be used for different access points, such as the femoral artery, subclavian artery, direct aorta, or apex of the heart.
The catheter also has special features that allow for precise positioning – and partial repositioning (if necessary) – of Optimum TAV.
Optimum TAV’s catheter is an investigational device and not available for commercial sale in the U.S. or any other region.