A new TAVR protection device catches debris beyond the brain. Can Emboline turn engineering superiority into clinical value?
Emboline’s Emboliner has received FDA 510(k) clearance after a randomized head-to-head trial showed similar 30-day clinical outcomes to Boston Scientific’s Sentinel but substantially greater debris capture and higher deployment success. The device now faces a commercial question its pivotal trial could not fully answer: whether protecting more of the circulation ultimately improves patient outcomes.