#USA #TAVR #Santa Cruz #Emboliner #ACC 2026

Emboline's Groundbreaking Results from the PROTECT H2H Trial

Emboline, Inc., a California-based medical technology company, made significant strides in cardiac interventions by announcing the positive results from their pivotal PROTECT H2H global clinical trial. This trial evaluated the performance of the Emboliner® Embolic Protection System, aimed to enhance outcomes for patients undergoing transcatheter aortic valve replacement (TAVR). The results were unveiled at the prestigious American College of Cardiology's Annual Scientific Session & Expo (ACC 2026) by Dr. Adam B. Greenbaum, showcasing the potential of Emboliner to redefine embolic protection in TAVR.


The PROTECT H2H trial stands out as the first randomized investigational device exemption (IDE) trial specifically designed to assess an embolic protection device within TAVR settings. Remarkably, it met all primary and secondary safety and efficacy endpoints, marking a commendable achievement in clinical and regulatory contexts. The study illustrated that the Emboliner device surpassed the leading control device, Sentinel CPS from Boston Scientific, by capturing significantly more debris and achieving superior procedural success rates.


The trial enrolled 522 patients with severe aortic stenosis eligible for TAVR, randomly assigning them to either the Emboliner or the control device. This milestone study commenced in May 2023, with patient follow-ups wrapping up by December 2025. It demonstrated an impressive combination of clinical, procedural, and product performance outcomes:

• - Primary Endpoint: The combined safety and efficacy endpoint, measured by the 30-day major adverse cardiac and cerebrovascular events (MACCE), was met with the Emboliner demonstrating statistical non-inferiority compared to the control (4.5% vs. 5.0%; p=0.0004).
• - Secondary Endpoints: The secondary safety endpoint, focusing on 30-day stroke rates (VARC 2), was also satisfied, showcasing a non-inferiority of Emboliner (2.0% vs. 2.1%; p=0.0001).
• - In terms of efficacy, the study revealed Emboliner's statistical superiority in debris capture (93 vs. 31 particles ≥ 150µm; p < 0.0001), alongside a notable technical success rate favoring Emboliner (95.9% vs. 87.1%; p=0.0005).

Both the safety profiles of each group indicated no significant differences related to access site injury or major bleeding complications. These promising results affirm that the Emboliner system not only maintains comparable safety outcomes but also excels in effectively capturing embolic debris, confirming its potential as a reliable solution during TAVR procedures.


Scott Russell, the President and CEO of Emboline, expressed his enthusiasm for these results, asserting their pivotal nature for the company and the broader landscape of embolic protection during TAVR. He added, "The Emboliner is engineered to capture and remove debris while seamlessly integrating into the procedural workflow, distinguishing it as a fundamental advancement in structural heart interventions. We are eager to submit these findings for regulatory approval and further enhance patient outcomes."

As the clinical landscape for TAVR procedures evolves, the demand for comprehensive embolic protection solutions similarly progresses. Dr. Tamim Nazif, a notable expert in the cardiovascular field, underscored the universal challenge posed by embolic debris during TAVR and emphasized the supporting data of Emboliner's safety and efficacy as a more holistic embolic protection method. Moreover, Dr. Adam B. Greenbaum highlighted the critical importance of these findings, especially as TAVR extends to larger and more intricate patient groups.

In approaching commercialization, Emboline enters a transformative phase with detailed, strong pivotal data now available, positioning the Emboliner as a probable new standard for embolic protection solutions in patients undergoing TAVR.