A Filter That Catches Debris During Heart Valve Procedures
Emboline's Emboliner, cleared by the FDA in September 2026, uses a two-layer mesh filter to catch debris during TAVR before it can reach the brain or kidneys.
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Emboline
Debris That Travels Through the Bloodstream
During
a TAVR procedure, pieces of material such as calcified valve tissue, blood
clots and foreign matter can break loose and enter circulation. Emboline states
that this debris release occurs in every TAVR procedure, and that studies have
found hundreds to thousands of particles entering the bloodstream during each
one. The company lists stroke, cognitive decline and acute kidney injury among
the complications such debris can cause, and says competing systems cover only
selected vessels leading to the brain.
A Two-Layer Mesh With a Channel Through the Middle
The
Emboliner uses a circumferential dual-layer filter made of nitinol mesh, a
metal alloy, designed to balance blood flow with debris capture. A central
working lumen, an open channel through the middle of the filter, lets the TAVR
delivery system pass through, and an integrated port allows blood to keep
flowing while particles are filtered out. The device is designed to protect
both the brain and the rest of the body, including the kidneys, is compatible
with leading self-expanding and balloon-expandable TAVR systems, and is
retrieved once the procedure is complete.
Tested Head-to-Head Against Another System
Emboline's
pivotal PROTECT H2H trial, presented as a late-breaking study at ACC 2026 with
results announced on March 30, 2026, randomized 522 patients with severe aortic
stenosis, a narrowing of the aortic valve, to receive either the Emboliner or
Boston Scientific's SENTINEL Cerebral Protection System. Enrollment ran from
May 2023 to December 2025. At 30 days, the combined rate of major adverse
cardiac and cerebrovascular events was 4.5% with the Emboliner and 5.0% with
the comparison device, and stroke rates were 2.0% and 2.1%. Both results met
the trial's non-inferiority goals, meaning the Emboliner performed no worse
than the comparison system.
What the Trial Found on Debris
Debris
capture, measured for particles 150 micrometers or larger, came to 93 for the
Emboliner and 31 for the comparison device, a statistically significant
difference. Technical success reached 95.9% with the Emboliner compared with
87.1% for the comparison device, and access site injury and major bleeding did
not differ significantly between the two groups. Emboline describes the
technical success rate as the highest ever reported for a TAVR embolic
protection device in a pivotal clinical study.
What the Trial Found on Debris
Debris
capture, measured for particles 150 micrometers or larger, came to 93 for the
Emboliner and 31 for the comparison device, a statistically significant
difference. Technical success reached 95.9% with the Emboliner compared with
87.1% for the comparison device, and access site injury and major bleeding did
not differ significantly between the two groups. Emboline describes the
technical success rate as the highest ever reported for a TAVR embolic
protection device in a pivotal clinical study.
First Procedures at Columbia
The
first commercial Emboliner cases were two TAVR procedures on October 1, 2026,
at New York-Presbyterian/Columbia University Irving Medical Center, performed
by Tamim Nazif, MD, who co-directs the center's Structural Heart and Valve
Center and served as co-principal investigator of PROTECT H2H. Nazif said,
"Stroke and embolic debris remain concerns during TAVR, and there remains
an unmet clinical need for more comprehensive and effective embolic protection
for our patients." Emboline is launching in a controlled way, starting
with leading structural heart centers, and CEO Scott Russell called the first
cases "a defining milestone for Emboline."
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