Regulatory process begins for stenting platform for bifurcation lesions

Advanced Bifurcation Systems announced that it has filed a pre-submission with the FDA to define its clinical pathway leading to a PMA for its new bifurcation stenting platform designed to reduce the need for open-heart surgery and standardize treatment of all bifurcation lesions in coronary angioplasties.

The company is also defining its regulatory and clinical strategy to obtain a CE Mark for the technology, according to a company press release.

“Current statistics for bifurcation stenting show the highest stenting failure rates resulting in repeat revascularization procedures,” Mehran Khorsandi, MD, interventional cardiologist and member of the HARTS stent team at Cedars-Sinai Medical Center and co-founder and Chief Medical Officer of Advanced Bifurcation Systems, stated in the release. “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.”

Khorsandi and Advanced Bifurcation Systems Chief Executive Officer Charles Laverty told Cardiology Today’s Intervention at TCT 2018 that bifurcation stenting via the new platform is “predictable, simple and reproducible,” resulting in a reduced procedure time, with lower radiation exposure and less use of contrast.

Stenting for left main bifurcation disease has traditionally posed challenges in terms of angles, sizes, plaque location and morphology, and linear stents for these procedures, usually deployed with provisional T, culotte and crush techniques, have limitations including access difficulties and frequent tissue injury, Laverty and Khorsandi told Cardiology Today’s Intervention.

The Advanced Bifurcation Systems patented bifurcation stenting platform aims to standardize the treatment of all bifurcation lesions in coronary angioplasties. The platform addresses main and side branches in four steps and uses bifurcating stents deployed on a Mother/Daughter monorail to branch and self-align covering bifurcations with no gaps and utilizes a dual-catheter system to move stents into position in one continuous process, Laverty and Khorsandi told Cardiology Today’s Intervention. The platform eliminates gaps or overlaps and tangling of wires associated with current stent installations.

“Our stenting platform reduces the need for repeat procedures and enables effective bifurcation stenting treatment,” Laverty stated in the release. “This simple procedure addresses a significant portion of patients who otherwise would be referred to open-heart surgery.”