Emboline has reported the first commercial use of its Emboliner Embolic Protection System in the US during two procedures involving transcatheter aortic valve implantation.
The procedures were conducted at New York-Presbyterian/Columbia University Irving Medical Center under the direction of Structural Heart and Valve Center hospital co-director and PROTECT H2H study co-principal investigator Dr Tamim Nazif.
The initial clinical use follows 510(k) clearance granted by the US Food and Drug Administration (FDA) in September 2026.
Indicated for transcatheter aortic valve replacement (TAVR), the Emboliner system is engineered to capture and extract debris generated during surgery.
By offering comprehensive full-body embolic coverage, the device works to prevent stray particles from migrating to vital organs or the brain.
Emboline president and CEO Scott Russell said: "Completing the first commercial Emboliner procedures in the US represents a defining milestone for Emboline and, more importantly, brings a new embolic protection option to physicians and their patients.
“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 US.
“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.”
Dr Nazif said: “Stroke and embolic debris remain concerns during TAVR, and there remains an unmet clinical need for more comprehensive and effective embolic protection for our patients.
“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.”
Following these initial procedures, the California-based medical device developer is initiating a controlled commercial rollout across selected US structural heart centres.
Emboline develops technologies intended to reduce embolic risks during transcatheter cardiovascular interventions.
