Santa Cruz, Calif. – October 02, 2026 -- Emboline, Inc. completed the first commercial use of its Emboliner® Embolic Protection System in the United States on October 1, 2026, just weeks after receiving U.S. Food and Drug Administration 510(k) clearance.
Two TAVR procedures mark Emboline's commercial debut
The device was deployed during two transcatheter aortic valve implantation (TAVR) procedures performed by Tamim Nazif, MD, Co-Director of the Structural Heart and Valve Center at New York-Presbyterian/Columbia University Irving Medical Center. Dr. Nazif also serves as Co-Principal Investigator of the PROTECT H2H clinical trial, which evaluated the Emboliner's performance ahead of regulatory approval.
FDA clearance in September 2026 preceded rapid rollout
Emboline received 510(k) clearance for the Emboliner in September 2026, with the first commercial case occurring within three weeks of that approval. The system is indicated for use during TAVR procedures and is designed to capture and remove embolic debris throughout the body, reducing the risk of stroke-related complications.
CEO cites speed of execution from clearance to first case
"Completing the first commercial Emboliner procedures in the U.S. represents a defining milestone for Emboline," said Scott Russell, President and Chief Executive Officer of Emboline. He noted the company's team enabled the first commercial case within three weeks of clearance, crediting collaboration with the New York-Presbyterian/Columbia team.
Physician points to unmet need for embolic protection in TAVR
Dr. Nazif said stroke and embolic debris remain ongoing concerns during TAVR procedures, describing an unmet clinical need for more comprehensive protection technology. He said his team's experience leading the PROTECT H2H trial positioned them to offer the Emboliner to a broader patient population now that it is commercially available.
Launch targets leading structural heart centers first
Emboline is initiating a controlled U.S. commercial launch, prioritizing deployment at leading structural heart centers before broader distribution.