Clinical Case Demonstrations

Introduction

Current dedicated “bifurcation stent” systems are either side-branch stents or main branch stents with a side-hole, used in a “side-branch first” or “main-branch first” deployment method.

“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.