Boston Scientific Gets FDA Approval for Intravascular Ultrasound

It's designed to provide high-quality IVUS vessel imaging.

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Boston Scientific

Boston Scientific announced the FDA clearance of the AVVIGO+ Multi-Modality Guidance System, a next-generation intravascular ultrasound (IVUS) and fractional flow reserve (FFR) system with advanced software and hardware features designed to provide high-quality IVUS vessel imaging and physiology experience during percutaneous coronary intervention (PCI) procedures. Building upon the AVVIGO Guidance System II, this technology helps to inform treatment decisions and enable faster, more efficient treatment procedures such as angioplasties and atherectomies for patients with coronary artery disease. The company also recently received CE Mark, with launch anticipated early next year.

Key features of the AVVIGO+ system include: 

  • First IVUS system with an artificial intelligence (AI) software called Automated Lesion Assessment to automate key procedural steps and provide precise vessel measurements 
  • Reduces procedure time significantly by acquiring IVUS images at a faster speed 
  • Provides enhanced guidance by drawing a physiology graph that helps to provide 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.” 

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