Emboline has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Emboliner embolic protection system, intended for use in transcatheter aortic valve replacement (TAVR) and other heart procedures.
The device is indicated to capture and remove embolic material during TAVR, providing protection for both cerebral and systemic circulation.
It employs a circumferential dual-layer filter that covers the cerebral and systemic arteries, aiming to intercept and extract debris generated during the TAVR procedure before it reaches critical organs such as the brain and kidneys.
This design enables the TAVR delivery system to be advanced through a central lumen within the filter, which, according to the company, differentiates it from other embolic protection devices that only shield selected cerebral vessels.
The FDA's decision follows an extensive clinical assessment of the Emboliner, including the multi-centre, prospective, randomised PROTECT H2H IDE study.
The investigation compared the system to the SENTINEL cerebral protection system in TAVR patients.
Emboline reports that the study achieved its primary safety and clinical performance measures and found that the system captured a significantly greater amount of clinically relevant debris.
Emboline president and CEO Scott Russell said: “FDA 510(k) clearance represents a defining moment for Emboline and for the physicians who have supported our vision since the company's founding. 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.”
Emboline plans to begin a phased commercial launch of Emboliner in the US later in the year, including physician training and selected centre rollouts, with ongoing collection of clinical experience.
In March 2026, Emboline raised $20m to advance commercial activities associated with its device for reducing stroke and ischemic damage during structural heart procedures such as TAVR.
