Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System

Clearance brings full cerebral and systemic embolic protection to patients undergoing transcatheter aortic valve replacement (TAVR)

SANTA CRUZ, Calif., Sept. 9, 2026 /PRNewswire/ -- Emboline, Inc., a medical technology company developing next-generation embolic protection technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Emboliner^® Embolic Protection System for use during transcatheter heart procedures. The Emboliner is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement (TAVR).

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. Unlike embolic protection devices that cover selected cerebral vessels, the Emboliner 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.

FDA clearance is supported by extensive clinical evaluation of the Emboliner, including the prospective, multicenter, randomized PROTECT H2H IDE study comparing the Emboliner with the SENTINEL™ Cerebral Protection System during TAVR. The study met its primary safety and clinical performance objectives and demonstrated significantly greater capture of clinically relevant debris with the Emboliner, as well as the highest technical success ever reported for a TAVR embolic protection device in a pivotal clinical study.

"FDA 510(k) clearance represents a defining moment for Emboline and for the physicians who have supported our vision since the company's founding," said Scott Russell, President and Chief Executive Officer of Emboline. "We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR. We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point."

"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," said Tamim Nazif, MD, Co-Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center and Co-Principal Investigator of the PROTECT H2H study. "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."

"Emboline was founded on a simple but ambitious idea: that we could do more to protect patients from embolic debris released during TAVR," said Amir Belson, MD, Founder of Emboline. "FDA clearance of the Emboliner represents the culmination of years of innovation, engineering and clinical research to bring that idea to life. I am incredibly proud of the team that has made this possible, and excited to see this technology become available to physicians and patients in the United States."

Emboline plans a phased commercial launch in the United States beginning later this year, accompanied by physician training, selected center rollouts, and continued collection of real-world clinical experience.

About Emboline

Emboline, Inc. is a privately held medical technology company based in Santa Cruz, California, focused on developing technologies designed to reduce embolic complications during transcatheter cardiovascular procedures.

The company's lead product, the Emboliner® Embolic Protection System, is designed to provide full cerebral and systemic embolic protection by capturing and removing debris that may be released during transcatheter interventions and could otherwise travel to the brain and other vital organs. Emboline's technologies are derived from intellectual property invented by serial medical device entrepreneur Amir Belson, MD, founder of NeoGuide Systems, Vascular Pathways, ZipLine Medical, Venocare, Radiaction, Modular Surgical, and Follisave.

For more information, visit emboline.com.

Media & Investor Contact: [email protected]

View original content to download multimedia:https://www.prnewswire.com/news-releases/emboline-receives-us-fda-510k-clearance-for-emboliner-embolic-protection-system-302873269.html

SOURCE Emboline, Inc.