Boston Scientific’s Avvigo+ Guidance System Receives FDA Clearance and CE Mark Approval

September 27, 2023—Boston Scientific announced FDA clearance of the company’s Avvigo+ multimodality guidance system. Aviggo+ is the company’s next-generation intravascular ultrasound (IVUS) and fractional flow reserve (FFR) system. The company also recently received CE Mark approval in Europe with a launch anticipated for early 2024.

According to the company, the system’s advanced software and hardware features are designed to provide high-quality IVUS vessel imaging and physiology experience during percutaneous coronary intervention procedures.

The new device, which builds upon the Avvigo guidance system II, helps to inform treatment decisions, and enables faster, more efficient treatment procedures such as angioplasties and atherectomies for patients with coronary artery disease.

Boston Scientific outlined key features of the Avviigo+ system as follows:

• The company’s Automated Lesion Assessment artificial intelligence software automates key procedural steps and provides precise vessel measurements.
• Procedure time is reduced significantly by acquiring IVUS images at a faster speed.
• Enhanced guidance is provided by drawing a physiology graph that creates a roadmap to treat the diseased coronary artery.