FEops HeartGuide Platform Cleared by FDA for LAAO Planning With Watchman Device

October 14, 2021—FEops announced that it received de novo authorization from the FDA for the company’s HeartGuide for left atrial appendage occlusion (LAAO) with the Watchman device (Boston Scientific Corporation). The HeartGuide is a cloud-based preprocedure planning platform for structural heart interventions that uses digital twin technology based on patient-specific virtual replicas of the heart.

According to the company, the HeartGuide will enable physicians to virtually model clinical scenarios with different implant positions and sizes of the Watchman device, helping the heart team to select the optimal size and position for every individual patient.

“The preoperative insight provided by FEops HeartGuide is powerful and can help me to optimize decision making for selecting optimal device size and position,” commented Jacqueline Saw, MD, in the company’s announcement. “FEops HeartGuide is an intuitive platform I can use to discuss cases with the entire heart team to streamline my pre-op planning workflow.” Dr. Saw is with Vancouver General Hospital in Vancouver, Canada.

In addition to the FDA clearance with its LAAO workflow with Watchman, the HeartGuide is commercially available in the European Union, United Kingdom, Canada, and Australia for its transcatheter aortic valve implantation and LAAO workflows, advised the company.