Advanced Bifurcation Systems Inc. Receives FDA Breakthrough Device Designation

2023-10-23

LIVERMORE, Calif., Oct. 23, 2023 /PRNewswire/ -- Advanced Bifurcation Systems Inc. (ABS), a pioneer in comprehensive solutions for bifurcation lesions in coronary angioplasty, today announced that it has received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology.

This prestigious designation is granted to devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The ABS platform stands out for its innovative approach to treating coronary artery bifurcations, reducing the need for open-heart surgery, hospitalizations, and repeat procedures, thereby significantly improving patient care outcomes and reducing healthcare costs.

"Advanced Bifurcation Systems receives FDA Breakthrough Device Designation"

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"The FDA's Breakthrough Device Designation is a testament to the potential of our technology to address a critical unmet need in interventional cardiology," said Dr. Mehran Khorsandi, CEO of Advanced Bifurcation Systems. "Our unique stenting technology is designed to simplify procedures, improve patient outcomes, and reduce angioplasty times, marking a significant advancement in coronary treatments."

The Breakthrough Devices Program will offer ABS the opportunity for more interactive and efficient communication with the FDA during the premarket review phase. This designation also allows for a prioritized review of the technology, highlighting its significance and potential for positive patient impact.

For more information about Advanced Bifurcation Systems and its revolutionary approach to coronary artery bifurcation stenting, visit www.advancedbifurcation.com

Contacts:

Advanced Bifurcation Systems, Inc.

Dr. Mehran Khorsandi

Chairman & CEO

[email protected]

Henry Bourang

President & COO

[email protected]

Ken Richards

CAO/CFO

[email protected]

SOURCE Advanced Bifurcation Systems