ABS - Bifurcation Stent Systems

“Side-branch first” stents require re-wiring side branches thru stent struts TWICE as well as requirement of an ADDITIONAL stent in the main branch with more than one layer of stent.

“Main-branch first” stents have the issue of proper orientation of the side-hole towards the side-branch causing lack of consistent coverage of the side-branch ostium

The ABS® Modular Bifurcation System is a novel hybrid stent platform. The main-branch stent is oriented first towards the side branch before full deployment. The system is designed for automatic orientation and alignment of main branch and side branch (stents) with complete coverage of carina and side-branch access.

The ABS device is a modular, dual-catheter, independently movable system. It consists of a mother-daughter stent (MDS) on an over-the-wire balloon catheter (MD) and a daughter stent (DS) or just balloon on a monorail daughter catheter. The daughter catheter is loaded on a sleeve of the MD catheter and protrudes through an opening in the middle of the MD stent and leads the system.

In case of the bifurcating stent assembly, the DS delivery balloon is twice the length of the DS which is mounted on the distal half of this balloon. In case of the bifurcation stent the daughter balloon catheter does not have a stent mounted.

Bifurcating stent (for complete coverage of the 3 limbs), Bifurcation stent (for the main branch only), and Ostial stent (side-branch only free-standing) are in development based on this technology. Specially designed stents in consideration of the size of the left main bifurcation are also in development for both bifurcating and bifurcation stent deployments in the left main coronary arteries.

Simple Deployment Method

The system is loaded on 2 wires and advanced until it reaches the carina. The leading DS catheter is then pulled back into the MD stent so that the proximal markers of the two balloons are aligned. The bifurcation stent is now assembled at the carina. The DS balloon is inflated first and partially deploys and rotates the proximal segment of the MD to align with the daughter vessel automatically. It simultaneously deploys the DS. The MD balloon is inflated to deploy the MD stent. Kissing balloon inflation fully deploys the system. The stents are sized on the basis of Murray’s law, obviating the need of additional balloons for completion of the procedure.

This two minute animation shows in idealized form a procedure that is likely to take the cardiologist about 10 minutes. A vessel bifurcation with lesions in a 1.1.1 plaque pattern is shown. The ABS® system is introduced through the PCI procedure and the stenting system is shown perfectly aligned following inflation of the mother and daughter balloons. The system of delivery ensures automatic alignment and perfect positioning of a bifurcating stent.

The platform consists of a dual-catheter independently moveable, modular system. The hybrid over-the-wire _ monorail system mitigates the issue of wire wrap. The system is advanced over one monorail wire into the coronary and the second wire is only advanced just before the mother catheter gets out of the guide catheter. Our propriety crimping technology allows for partial crimping of the mother stent which is necessary to have the“monorail in monorail” independently movable modular system. Alignment / phase-shift / orientation is automatic with our system and delivery mechanism and does not require a new skill set. This is because of several design factors of the ABS delivery platform. The side-hole is oriented towards the side branch over the shaft of the daughter catheter and not just a side-branch wire.The pull back of the daughter catheter into the mother stent, as facilitated by the mother catheter sleeve rotates the mother catheter and stent as necessary. And finally inflating the daughter balloon which partially deploys the proximal segment of the mother stent simultaneously with the daughter stent guarantees perfect positioning, as well as coverage of the “vulnerable zone”. That is why our stents are designed to evenly scaffold every bifurcation. Our systems are sized on the basis of Murray’s law, obviating the need of additional balloons for completion of the procedure.

PROVISIONAL Side Branch Stenting

The platform consists of a dual-catheter independently moveable, modular system. The hybrid over-the-wire _ monorail system mitigates the issue of wire wrap. The system is advanced over one monorail wire into the coronary and the second wire is only advanced just before the mother catheter gets out of the guide catheter. Our systems are sized on the basis of Murray’s law, obviating the need of additional balloons for completion of the procedure. Our propriety crimping technology allows for partial crimping of the mother stent which is necessary to have the“monorail in monorail” independently movable modular system. Alignment / phase-shift / orientation is automatic with our system and delivery mechanism and does not require a new skill set. This is because of several design factors of the ABS delivery platform. The side-hole is oriented towards the side branch over the shaft of the daughter catheter and not just a side-branch wire.The pull back of the daughter catheter into the mother stent, as facilitated by the mother catheter sleeve rotates the mother catheter and stent as necessary. And finally inflating the daughter balloon which partially deploys the proximal segment of the mother stent, guarantees perfect positioning, as well as coverage of the “vulnerable zone”. That is why our stents are designed to evenly scaffold every bifurcation. Our systems are sized on the basis of Murray’s law, obviating the need of additional balloons for completion of the procedure.