Advanced Bifurcation Systems
Advanced Bifurcation Systems (ABS) is a California-based medical device company revolutionizing the treatment of coronary bifurcation lesions. The company has developed a proprietary stent delivery platform designed for efficiency and precision, addressing an unmet need in cardiovascular care. With a focus on simplifying bifurcation stenting, ABS aims to improve patient outcomes, reduce healthcare costs, and make advanced bifurcation treatment accessible to all interventional cardiologists. The company has received FDA Breakthrough Device Designation, secured over 75 patents, and has completed successful first-in-human trials, positioning itself as a potential industry standard.
Industries
Nr. of Employees
small (1-50)
Advanced Bifurcation Systems
7419 Southfront Rd., Livermore, CA 94551
Patents
Multi-stent and multi-balloon apparatus for treating bifurcations and methods of use
US-12324757-B2
View Details
Multi-stent and multi-balloon apparatus for treating bifurcations and methods of use
US-12324757-B2
View DetailsProducts
Modular bifurcation stent delivery platform
A stent delivery platform engineered to treat coronary bifurcation lesions using a modular dual‑catheter approach that assembles main‑branch and side‑branch components at the carina for simultaneous deployment and access to the side branch.
Bifurcating, bifurcation and ostial stent configurations (in development)
Variants of stent implants under development including full bifurcating stents (covering three limbs), main‑branch only bifurcation stents, and ostial (side‑branch) stents designed for integration with the delivery platform.
Modular bifurcation stent delivery platform
A stent delivery platform engineered to treat coronary bifurcation lesions using a modular dual‑catheter approach that assembles main‑branch and side‑branch components at the carina for simultaneous deployment and access to the side branch.
Bifurcating, bifurcation and ostial stent configurations (in development)
Variants of stent implants under development including full bifurcating stents (covering three limbs), main‑branch only bifurcation stents, and ostial (side‑branch) stents designed for integration with the delivery platform.
Services
End‑to‑end clinical program services including protocol development, IRB submissions, CRF management, site coordination, CRO oversight, patient enrollment support, and post‑market clinical follow‑up.
Preparation and management of regulatory strategies and submissions for high‑risk medical devices, including interactions for Breakthrough Device Designation and IDE/clinical study planning.
Engineering, CAD design, prototype builds, assembly, incoming/in‑process/final inspection, and production support for stent delivery systems and related components.
QMS implementation and maintenance, supplier qualification and audits, process and equipment qualification (IQ/OQ/PQ), and support for design verification/validation activities.
End‑to‑end clinical program services including protocol development, IRB submissions, CRF management, site coordination, CRO oversight, patient enrollment support, and post‑market clinical follow‑up.
Preparation and management of regulatory strategies and submissions for high‑risk medical devices, including interactions for Breakthrough Device Designation and IDE/clinical study planning.
Engineering, CAD design, prototype builds, assembly, incoming/in‑process/final inspection, and production support for stent delivery systems and related components.
QMS implementation and maintenance, supplier qualification and audits, process and equipment qualification (IQ/OQ/PQ), and support for design verification/validation activities.
Expertise Areas
- Clinical trial management for high‑risk medical devices
- Interventional cardiology device development
- Bifurcation stent delivery platform design
- Combination device and drug‑eluting stent R&D
Key Technologies
- Modular bifurcation stent delivery platforms
- Dual‑catheter (mother–daughter) delivery architecture
- Over‑the‑wire and monorail catheter systems
- Automatic mechanical orientation/alignment mechanisms
News & Updates
ABS received FDA’s Breakthrough Device Designation for its coronary artery bifurcation stenting technology.
ABS announced the first closing of its Series A financing round, raising $20.8 million.
ABS secured additional funding and expanded its Board of Directors with strategic investors.
The company’s innovative bifurcation stenting technology has been recognized by the FDA for its potential to revolutionize coronary treatments.
ABS has raised over $20 million in its Series A round, supporting regulatory and market expansion.
Recognition by the FDA for innovative coronary bifurcation stenting technology.
ABS received FDA’s Breakthrough Device Designation for its coronary artery bifurcation stenting technology.
ABS announced the first closing of its Series A financing round, raising $20.8 million.
ABS secured additional funding and expanded its Board of Directors with strategic investors.
The company’s innovative bifurcation stenting technology has been recognized by the FDA for its potential to revolutionize coronary treatments.
ABS has raised over $20 million in its Series A round, supporting regulatory and market expansion.
Recognition by the FDA for innovative coronary bifurcation stenting technology.