Emboline Launches Emboliner System in U.S. Market
Two transcatheter aortic valve implantation procedures at New York-Presbyterian/Columbia University Irving Medical Center marked the first commercial use of the Emboliner Embolic Protection System. This milestone arrives just three weeks after the device received 510(k) clearance from the U.S. Food and Drug Administration to mitigate risks during structural heart interventions.
Dr. Tamim Nazif, co-director of the Structural Heart and Valve Center, performed the inaugural procedures on October 1, 2026. The Emboliner is engineered to capture and remove debris generated during transcatheter aortic valve replacement, addressing clinical concerns regarding stroke and embolic complications. Having served as a co-principal investigator for the PROTECT H2H study, Dr. Nazif noted that the technology fills a significant gap in patient care by providing more comprehensive protection than previous alternatives.
Emboline, based in Santa Cruz, is now initiating a controlled rollout targeting leading structural heart centers across the country. Scott Russell, the company’s president and CEO, credited the rapid transition from regulatory approval to clinical application to the internal team's performance. The system, rooted in intellectual property developed by serial entrepreneur Dr. Amir Belson, is currently positioned as a key tool for clinicians aiming to reduce the incidence of debris traveling to the brain and other vital organs during complex cardiovascular procedures.
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