Emboliner Embolic Protection System for TAVR Launched in the United States

October 2, 2026—Emboline, Inc. announced the commencement of a controlled commercial launch in the United States of its Emboliner embolic protection system. The launch will be focused initially on leading structural heart centers.

According to the company, Tamim Nazif, MD, conducted the first commercial uses of the Emboliner system in two transcatheter aortic valve replacement (TAVR) procedures. Dr. Nazif is Codirector of the Structural Heart and Valve Center at New York-Presbyterian/Columbia University Irving Medical Center in New York, New York.

Additionally, Dr. Nazif served as Coprincipal Investigator of the PROTECT H2H study, which supported regulatory clearance of the Emboliner in the United States.

As noted in the press release, Emboline received FDA 510(k) clearance for the Emboliner in September 2026. The company stated that the device is designed to provide full-body embolic protection by capturing and removing debris generated during transcatheter structural heart procedures. It is currently indicated for use during TAVR.

“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,” commented Dr. Nazif in the Emboline press release. “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.”