Emboliner Embolic Protection System Cleared by FDA for TAVR

September 10, 2026—Emboline, Inc. announced that the FDA has granted 510(k) clearance for the Emboliner embolic protection system to capture and remove embolic material during transcatheter aortic valve replacement (TAVR).

The company advised that it plans a phased commercial launch in the United States beginning in 2026, accompanied by physician training, selected center rollouts, and continued collection of real-world clinical experience. In March, Emboline announced it had closed $20 million in growth capital to support preparations for the commercial introduction of the Emboliner.

According to the company, the Emboliner system is designed to provide comprehensive cerebral and systemic embolic protection during TAVR by capturing and removing embolic debris before it can travel to the brain, kidneys, and other vital organs. The device uses a circumferential dual-layer filter to protect the cerebral and systemic circulation while allowing the TAVR delivery system to pass through its central working lumen, noted the press release.

Emboline stated that FDA clearance is supported by the results of the PROTECT H2H study comparing the Emboliner with a control device (Sentinel cerebral protection system; Boston Scientific Corporation) during TAVR.

The prospective, multicenter, randomized study was conducted under an investigational device exemption. The company announced enrollment of the study’s first patient in May 2023.

The head-to-head study met its primary safety and clinical performance objectives and demonstrated significantly greater capture of clinically relevant debris with the Emboliner, as well as high technical success, advised the company.

Tamim Nazif, MD, who is Coprincipal Investigator of the PROTECT H2H study, commented on the device in the Emboline press release.

“The liberation of embolic debris is a universal concern during TAVR, but until now our ability to provide comprehensive protection of both the cerebral and systemic circulation has been limited,” stated Dr. Nazif. “The Emboliner represents an important step forward, providing full brain and body protection, while integrating seamlessly into the TAVR procedure. Having this new capability may give physicians greater confidence when treating patients in whom embolic risk is an important consideration, and I look forward to incorporating this technology into our clinical practice.”