FDA Grants 510(k) Clearance to Emboliner System for TAVR Procedures

The U.S. Food and Drug Administration (FDA) has approved Emboliner, a cardiac protection system from Emboline, for percutaneous coronary intervention (TAVR) and other cardiac procedures. The device is designed to capture and remove embolic material generated during TAVR, protecting vital organs such as the brain and kidneys.

The Emboliner system uses a dual-layer annular filter to cover the brain and systemic arteries, designed to intercept and clear debris generated during TAVR procedures. Unlike other embolic protection devices that only shield selected cerebral vessels, this design allows the central lumen of the TAVR delivery system to pass through the filter, effectively enhancing the scope of protection.

The FDA's decision was made following a comprehensive clinical evaluation of Emboliner, including a multicenter, prospective randomized study——the PROTECT H2H IDE study. The study compared the Emboliner system with the SENTINEL cerebral protection system.

Study results showed that the system captured significantly more clinically relevant debris than the SENTINEL system and met its primary safety and clinical performance endpoints. This marks a significant milestone for Emboline and the physicians who have long supported its vision.

Scott Russell, President and CEO of the company, said: “FDA 510(k) clearance represents a milestone for Emboline and the physicians who have long supported our vision. We developed Emboliner to address some of the unmet needs of existing embolic protection approaches, particularly in TAVR procedures. We are excited to now make Emboliner available to physicians, enabling them to offer patients a more comprehensive embolic protection solution.”

Emboline plans a phased commercial launch in the United States later this year, including physician training and selected center rollouts, with ongoing collection of clinical experience. The company previously secured $20 million in financing in March 2026 to support commercial activities related to its device for reducing stroke and ischemic injury in structural heart procedures such as TAVR.

This innovative device not only represents a technological breakthrough but also reflects a continued commitment to patient safety and efficacy, promising to bring more reliable protection to TAVR procedures. By capturing and removing potential embolic material, the system aims to reduce the risk of procedure-related complications and bring better outcomes to patients.

Currently, Emboline is actively collaborating with medical institutions to provide training and support to physicians, ensuring the safe and effective application of the Emboliner system in clinical practice. In the future, as more clinical data and experience accumulate, the system is expected to further optimize its performance and benefit more patients.

In the future, Emboline plans to further expand the market reach of its products, promoting this innovative embolic protection system to medical institutions worldwide to provide more patients with high-quality medical services. The company will also continue to invest in research and development, driving innovation to contribute more advanced technologies and solutions to the field of structural heart interventions.

The company looks forward to working closely with medical professionals to jointly advance the development of TAVR procedures, bring better health and quality of life to patients, achieve new breakthroughs for the industry, and positively impact future models of diagnosis and treatment.