PROTECT H2H is the first randomized IDE trial of an embolic protection device in TAVR to meet all primary and secondary safety and efficacy endpoints, representing a significant clinical and regulatory achievement for the category. In addition, the study demonstrated superior debris capture and significantly higher technical success for Emboliner 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.
The prospective, randomized, controlled pivotal study enrolled 522 patients with severe aortic stenosis who were suitable for TAVR and randomized them 1:1 to either Emboliner or the control device, Sentinel CPS (Boston Scientific). Enrollment began in May 2023, with final patient follow-up completed in December 2025.
The study delivered a strong combination of clinical, procedural, and product performance outcomes across all key endpoints:
- Primary Endpoint: Combined safety and efficacy endpoint (30-day MACCE) was met, with Emboliner demonstrating statistical non-inferiority to control (4.5% vs. 5.0%; p for non-inferiority = 0.0004)
- Secondary safety/efficacy endpoint: (30-day stroke, VARC 2) was met, with Emboliner demonstrating statistical non-inferiority to control (2.0% vs. 2.1%; p for non-inferiority = 0.0001)
- Secondary efficacy endpoint: (debris capture, particles = 150µm) was met, with Emboliner 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
Together, these findings demonstrate that Emboliner delivered comparable clinical safety outcomes while outperforming the control device on key measures of debris capture and procedural performance.
"These results mark an important milestone for Emboline 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 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."
Unlike embolic protection devices which are designed to protect only select cerebral vessels, Emboliner 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.
"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. Importantly, the study also demonstrated the ease of use and high procedural success rates that are important in facilitating physician adoption of new devices."
"As TAVR expands across broader and more complex patient populations, we see embolic protection becoming increasingly important." said Adam B. Greenbaum, Associate Professor of Medicine, Co-director of the Emory Structural Heart and Valve Center at Emory University Medical Center, Investigator for the PROTECT H2H study at Emory and presenter of the late-breaking clinical study data at ACC 2026. "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."
With pivotal data now presented, Emboline is advancing toward regulatory submission and preparing for commercialization.
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 structural heart interventions and that 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.
The Emboliner device is currently investigational and is not available for commercial sale.
For more information, visit emboline.com.
Media & Investor Contact: media@emboline.com
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