Emboline has announced the first commercial use of its Emboliner embolic protection system.
The system was used during two transcatheter aortic valve implantation (TAVI) procedures performed by Tamim Nazif, co-director of the Structural Heart and Valve Center at New York-Presbyterian/Columbia University Irving Medical Center (New York, USA), co-principal investigator of the PROTECT H2H study.
The Emboliner is designed to provide full-body embolic protection by capturing and removing debris generated during transcatheter structural heart procedures and is currently indicated for use during TAVI. The system received US Food and Drug Administration 510(k) clearance in September 2026.
“Completing the first commercial Emboliner procedures in the USA represents a defining milestone for Emboline and, more importantly, brings a new embolic protection option to physicians and their patients,” said Scott Russell, president and CEO of Emboline. “We are grateful to Dr Nazif and the entire New York-Presbyterian/Columbia team for their leadership and collaboration as we begin the commercial introduction of the Emboliner in the USA. I am also incredibly proud of our highly motivated Emboline team, whose efforts enabled our first commercial case within three weeks of 510(k) clearance.”
“Stroke and embolic debris remain concerns during TAVI, and there remains an unmet clinical need for more comprehensive and effective embolic protection for our patients,” said Nazif. “We gained considerable experience with the Emboliner through our leadership of the PROTECT H2H clinical trial, and we are extremely excited to be able to offer this technology to a broader range of our patients now that it is commercially available.”
The company is commencing a controlled US commercial launch focused initially on leading structural heart centres.
