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Boston Scientific gets FDA clearance for intravascular ultrasound system

Boston Scientific has recently announced the FDA’s clearance of its Avvigo+ multi-modality guidance system. This next-generation system offers both intravascular ultrasound (IVUS) and fractional flow reserve (FFR) capabilities, leveraging advanced software and hardware to deliver exceptional IVUS vessel imaging and physiology assessments. Its applications encompass percutaneous coronary intervention (PCI) procedures.

Expanding on the foundation of the Avvigo guidance system II, this technology plays a pivotal role in informing treatment decisions, facilitating faster and more efficient procedures like angioplasties and atherectomies for patients grappling with coronary artery disease.

In addition to the FDA clearance, Boston Scientific has also obtained the CE mark for the multi-modality guidance system, with plans for an early launch in the coming year.

Key highlights of this system include the integration of AI software named “automated lesion assessment,” streamlining crucial procedural steps and delivering precise vessel measurements. Furthermore, it reduces procedure duration by expediting IVUS image acquisition. Finally, it enhances guidance through a physiology graph, offering a clear path to address coronary artery issues.

“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.”

© Boston Scientific

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