Advanced Bifurcation Systems Inc. (ABS), a leader in providing comprehensive solutions for treating coronary angioplasty's bifurcation lesions, has proudly announced its recognition by the U.S. Food and Drug Administration (FDA) with the Breakthrough Device Designation. This esteemed designation is reserved for devices displaying the potential to revolutionize the diagnosis and treatment of serious, life-threatening diseases or conditions.

ABS's platform is a standout in the field of coronary artery bifurcation treatment, offering an innovative approach that lessens the necessity for invasive open-heart surgery, frequent hospitalizations, and repetitive procedures. This not only enhances patient care outcomes but also significantly reduces healthcare costs. The FDA's Breakthrough Device Designation underscores the potential of our technology to meet a critical unmet need in interventional cardiology.

Being a part of the Breakthrough Devices Program affords ABS the opportunity for more streamlined and interactive communication with the FDA during the premarket review phase. Additionally, this designation guarantees a prioritized review for our technology, highlighting its significant impact and potential to bring about positive changes in patient care.

Source: prnewswire.com