Advanced Bifurcation System to seek FDA clearance for bifurcation tech IDE trial
Advanced Bifurcation Systems said this week it filed with the FDA seeking clearance for a trial it hopes will lead to an investigational device exemption for its bifurcation technology, and that it is also considering its options in pursuit of CE Mark approval in the European Union.
The Los Angeles-based company said it presented its technology platform at the Transcatheter Cardiovascular Therapeutics conference this week.
The company’s ABS system is a bifurcation stenting platform intended to standardize the treatment of bifurcation lesions in coronary angioplasties. ABS said that the two-catheter platform uses bifurcating stents deployed on a Mother/Daughter monorail to branch and self-align to cover bifurcations with no gaps.
“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,” CEO Charles Laverty said in a press release.
“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,” ABS co-founder Dr. Mehran Khorsandi of the Cedars-Sinai Medical Center said in a prepared release.