Emboline's Emboliner System Achieves Superior Debris Capture in Pivotal TAVR Protection Trial
Key Insights
Emboline (search)'s PROTECT H2H trial enrolled 522 patients and became the first randomized IDE study of an embolic protection device in TAVR to meet all primary and secondary safety and efficacy endpoints.
The Emboliner (search) system demonstrated statistical superiority in debris capture (93 vs. 31 particles ≥150μm; p < 0.0001) and significantly higher technical success rates (95.9% vs. 87.1%; p = 0.0005) compared to Boston Scientific's Sentinel CPS (search) control device.
The device achieved non-inferiority for key safety endpoints including 30-day MACCE (4.5% vs. 5.0%) and stroke (search) rates (2.0% vs. 2.1%), while providing comprehensive cerebral and systemic embolic protection during transcatheter aortic valve replacement procedures.
Emboline (search) announced positive results from its pivotal PROTECT H2H global clinical trial evaluating the Emboliner (search)® Embolic Protection System in patients undergoing transcatheter aortic valve replacement (TAVR). The results, presented as a Late-Breaking Clinical Trial at the American College of Cardiology's Annual Scientific Session & Expo (ACC 2026) by Adam B. Greenbaum, MD, represent the first randomized IDE trial of an embolic protection device in TAVR to meet all primary and secondary safety and efficacy endpoints.
Trial Design and Patient Population
The prospective, randomized, controlled pivotal study enrolled 522 patients with severe aortic stenosis (search) who were suitable for TAVR and randomized them 1:1 to either Emboliner (search) or the control device, Sentinel CPS (search) (Boston Scientific). Enrollment began in May 2023, with final patient follow-up completed in December 2025.
Primary and Secondary Endpoint Results
The study delivered strong outcomes across all key endpoints. The primary combined safety and efficacy endpoint (30-day MACCE) was met, with Emboliner (search) demonstrating statistical non-inferiority to control (4.5% vs. 5.0%; p for non-inferiority = 0.0004). The secondary safety/efficacy endpoint (30-day stroke (search), VARC 2) was also met, with Emboliner showing statistical non-inferiority to control (2.0% vs. 2.1%; p for non-inferiority = 0.0001).
Most notably, the secondary efficacy endpoint for debris capture (particles ≥150μm) was met, with Emboliner (search) demonstrating statistical superiority to control (93 vs. 31; p < 0.0001). Technical success significantly favored Emboliner (95.9% vs. 87.1%; p = 0.0005). No significant differences were observed between groups in access site injury or life-threatening or major bleeding.
Superior Performance Despite Learning Curve
The study demonstrated superior debris capture and significantly higher technical success for Emboliner (search) compared with the control device, despite all study operators having prior experience with only the control device and using Emboliner for the first time, underscoring the device's ease of adoption in real-world practice.
Clinical Significance and Expert Commentary
"The randomized data from the PROTECT H2H trial presented at ACC represent an important milestone for embolic protection in TAVR," said Tamim Nazif, MD, Director of Clinical Research in Cardiology at Columbia University Irving Medical Center and Co-Principal Investigator for the PROTECT H2H study. "The liberation of embolic debris is ubiquitous in TAVR procedures, and these results support the safety and efficacy of a more comprehensive protection solution with the Emboliner (search)."
Adam B. Greenbaum, Associate Professor of Medicine and Co-director of the Emory Structural Heart and Valve Center at Emory University Medical Center (search), noted the broader implications: "As TAVR expands across broader and more complex patient populations, we see embolic protection becoming increasingly important. What is compelling about these data is how they support a more comprehensive embolic protection approach, particularly as we think about broader use in structural heart and transcatheter procedures with even greater embolic burden than routine TAVR."
Technology Differentiation
Unlike embolic protection devices which are designed to protect only select cerebral vessels, Emboliner (search) is designed to provide full cerebral and systemic embolic protection, capturing and removing debris that may otherwise embolize to the brain and peripheral organs during structural heart intervention.
Regulatory Path Forward
"These results mark an important milestone for Emboline (search) and support our belief that embolic protection in TAVR must address the full scope of embolic risk," said Scott Russell, President and CEO of Emboline. "We designed the Emboliner (search) to capture and remove debris while integrating seamlessly into procedural workflow, and we believe this combination differentiates the technology in structural heart. We look forward to submitting the study data for consideration of regulatory approval."
With pivotal data now presented, Emboline (search) is advancing toward regulatory submission and preparing for commercialization. The Emboliner (search)® device is currently investigational and is not available for commercial sale.