Current Market

Currently, no other catheter insertion aids exist that are utilized widely in the TAVR procedure. Edwards Lifesciences's standard procedure is to grip the catheter shaft solely with a surgical glove. However, there are several purchasable catheter insertion aids on the market or patented. The majority of catheter insertion aids on the market are specifically for urinary catheters and are intended for personal, at-home use.

This is a reusable, washable aid that allows for catheter advancement by gripping the handle and tilting with the hand or wrist. It is intended for use by patients with quadriplegia or limited dexterity to empty the bladder.

This device snaps onto the middle of the hand and includes a lever that grips and releases the catheter.

These current insertion devices feature an external handle that moves the pushing motion off-axis; this does not only present a change of procedure for surgeons, but it also reduces the ease-of-use gained by advancing the catheter on-axis. Currently, surgeons grip the catheter with multiple fingers and advance it using 3-inch strokes along the axis of insertion for ease of insertion. Clinicians are trained in specific procedures and will be resistant to using a product that fundamentally changes how they insert the catheter.

These devices are intended for low-resistance insertion and will not be able to handle the necessary forces produced by the seals present in the delivery system and the E-sheath used during the TAVR procedure. The urethra is also a shorter route and has a less tortuous anatomy than the femoral artery used to access the aorta. The current products on the market are not designed for the sustained force and distance necessary in the TAVR procedure.

The TAVR market is $5.7 billion and 52.7% of that market is balloon expandable valves, which is where we come in. We’re selling to hospitals who already work closely with Edwards because of their high throughput of TAVR surgeries. The Squeeze Sleeve will be added into the TAVR kit, bundled with the delivery system, sheath, crimper, and SAPIEN 3 valve for a premium price.