USA — Boston Scientific has announced the FDA clearance for its Avvigo+ multi-modality guidance system, propelling healthcare innovation to new heights.
This next-generation system integrates intravascular ultrasound (IVUS) and fractional flow reserve (FFR), harnessing advanced software and hardware to deliver unparalleled IVUS vessel imaging and physiological insights.
The Avvigo+ is poised to revolutionize percutaneous coronary intervention (PCI) procedures, promising faster, more efficient treatments for patients with coronary artery disease.
Boston Scientific’s PCI division has been experiencing significant growth, particularly in China, as discussed during the company’s recent Investor Day.
This remarkable technology, an evolution of the Avvigo Guidance System II, promises to revolutionize treatment decision-making, empowering clinicians with faster, more precise insights for procedures like angioplasties and atherectomies.
The Avvigo+ multi-modality guidance system has also received the coveted CE mark, indicating compliance with European Union regulations. Its anticipated launch is scheduled for early next year.
Among its key features is the integration of AI software called automated lesion assessment, streamlining crucial procedural steps and delivering precise vessel measurements.
Moreover, the system drastically reduces procedure time by expediting IVUS image acquisition. It also provides enhanced guidance with a physiology graph, offering a clear roadmap for treating diseased coronary arteries.
Lance Bates, President of Interventional Cardiology Therapies at Boston Scientific, expressed enthusiasm about introducing U.S. clinicians to the Avvigo+ system, emphasizing its ability to enhance percutaneous coronary interventions.
“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,” he remarked.
In another impressive development, Boston Scientific secured approval from the Food and Drug Administration for its novel heart ablation device designed to treat atrial fibrillation in August.
The POLARx Cryoablation System stands out for its versatility, accommodating two balloon sizes in a single catheter.
This innovative approach enables physicians to tailor treatments to individual patients, a milestone in cardiac care.
The device has garnered success in Europe and Japan, where it received clearance for use. CEO Mike Mahoney noted the device’s strong performance in these markets during an earnings call, highlighting its positive reception.
Boston Scientific faces competition from companies like Johnson & Johnson and Medtronic, both of which are introducing new cardiac ablation devices to the market.
Cryoablation, a minimally invasive procedure utilizing a balloon catheter to freeze tissue near the pulmonary vein, aids in blocking irregular electrical signals responsible for atrial fibrillation.
The POLARx system’s ability to switch between two balloon sizes grants clinicians greater flexibility during procedures, reducing the need for device change-outs.
It also extends the range of pulmonary vein anatomies that can be effectively treated. Since its European approval in 2020 and Japanese clearance in 2021, the POLARx system has been deployed in over 25,000 patients worldwide, as affirmed by Boston Scientific Electrophysiology President Nick Spadea-Anello.
Boston Scientific’s electrophysiology division has seen impressive growth, with a 28% increase in the second quarter, driven by the outstanding performance of the POLARx and FARAPULSE cardiac ablation devices.
The company remains at the forefront of cardiac care innovation as competitors continue to conduct cardiac ablation studies and introduce new devices to the market.
Johnson & Johnson recently expanded the indication for some of its radiofrequency ablation devices, allowing their use without fluoroscopy imaging to reduce patient radiation exposure.
Meanwhile, Medtronic achieved CE Mark approval for its Affera device, providing physicians with the choice between pulsed field ablation and radiofrequency ablation.
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