Boston Scientific wins FDA nod for intravascular ultrasound system

Boston Scientific

(NYSE: BSX)
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announced today that the FDA cleared its Avvigo+ multi-modality guidance system.

The next-generation system provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures.

Boston Scientific’s PCI business continues to grow, particularly in China. The company touched on that and much more at its Investor Day last week — read more here.

Building upon the company’s Avvigo guidance system II, the technology helps to inform treatment decisions. It enables faster, more efficient procedures, such as angioplasties and atherectomies for patients with coronary artery disease.

Boston Scientific also received CE mark for the multi-modality guidance system. It anticipates the launch to begin early next year.

Key features include AI software called automated lesion assessment. It automates key procedural steps and provides precise vessel measurements. The system also reduces procedure time with more speed in acquiring IVUS images. Finally, it provides enhanced guidance with a physiology graph that provides a roadmap to treat the diseased coronary artery.

“We are pleased to introduce U.S. clinicians to the next-generation Avvigo+ multi-modality guidance system, which builds upon the AVVIGO Guidance System II and provides fast, intuitive and accurate vessel and lesion assessment capabilities for percutaneous coronary interventions,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “Coming on the heels of the updated ACC guidelines recommending intracoronary imaging during PCIs, we believe this enhanced and automated tool will help physicians optimize these procedures to provide better outcomes for their patients with coronary artery disease.”