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Advanced Bifurcation Systems Files Pre-Submission With FDA to Define Clinical Pathway; Outlines Regulatory and Clinical Strategy for Europe to Obtain CE Mark
LOS ANGELES, Sept. 21, 2018 (GLOBE NEWSWIRE) -- Advanced Bifurcation Systems (“ABS” or the “Company”), a clinical stage medical device company developing an innovative stenting platform which overcomes the limitations of current approaches for the treatment of bifurcation lesions in coronary angioplasties, today announced that the Company has submitted a proposal to the U.S. Federal Drug Administration (“FDA”) for a clinical study leading to an IDE for its bifurcation technology. Concurrently, the Company is defining a regulatory and clinical strategy for Europe to receive a CE mark.
Mr. Charles Laverty, Chief Executive Officer of Advanced Bifurcation Systems commented, “This is a major milestone in advancing our platform and moves us a step closer towards a PMA, and subsequent commercialization. We are anxious to receive guidance from the regulatory authorities and initiate clinical trials. Our regulatory team has made a tremendous effort to get us to this point and we appreciate their contributions.”
About Advanced Birfurcation Systems
Advanced Bifurcation Systems (“ABS”) is a clinical stage medical device company developing an innovative stenting platform for simple treatment of all bifurcation lesions in coronary angioplasties. ABS has developed a novel technology which overcomes the limitations of current approaches while simplifying the procedure. The Company’s groundbreaking system consists of numerous differentiating features, including a unique modular independently movable dual-catheter system for provisional side-branch stenting as well as full bifurcation stenting with a proprietary crimping technology allowing for partial crimping of the main stent. For more information, go to www.advancedbifurcation.com.
Advanced Bifurcation Systems
Chief Executive Officer