The platform features the only modular self-aligning stent technology to evenly scaffold bifurcations.
ABS co-founder and chief medical officer Mehran Khorsandi said: “Current statistics for bifurcation stenting show the highest stenting failure rates resulting in repeat revascularization procedures.
“In the absence of an effective reproducible technology for addressing left main bifurcation disease, most patients are referred for open-heart surgery. The ABS technology overcomes the limitations of current approaches while simplifying the procedure.”
The ABS platform is a unique single system addressing main and side branches offering a disruptive bifurcation stenting technique that:
uses bifurcating stents deployed on a Mother/Daughter (MD) monorail to branch and self-align covering bifurcations with no gaps;
Uses a dual-catheter system to move stents into position in one continuous process;
Eliminates gaps or overlaps and tangling of wires associated with current stent installations.
ABS CEO Charles Laverty said: “Our stenting platform reduces the need for repeat procedures and enables effective bifurcation stenting treatment.
“This simple procedure addresses a significant portion of patients who otherwise would be referred to open-heart surgery.”
ABS has filed a pre-submission with the FDA to define its clinical pathway leading to a PMA. The company also is defining its regulatory and clinical strategy for Europe to obtain a CE Mark.
Source: Company Press Release.
