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Boston Scientific

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Emboline’s FDA-cleared Emboliner system provides cerebral and systemic embolic protection during TAVR and captured substantially more debris than Sentinel in randomized testing. Representative image.
Features & Analysis

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.

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Medical Devices & Diagnostics

Emboliner captures more TAVR debris, but will FDA clearance translate into fewer strokes?

FDA clears Emboline’s Emboliner for embolic protection during TAVR, opening a U.S. launch after head-to-head testing against Sentinel.

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Medical Devices & Diagnostics

Boston Scientific FARAFLEX pivotal trial begins U.S. testing of single map-and-ablate PFA catheter

Texas Cardiac Arrhythmia Institute has performed the first U.S. procedure in Boston Scientific’s 571-patient FARAFLEX pivotal program evaluating integrated mapping and pulsed field ablation for paroxysmal and persistent AF.

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Medical Devices & Diagnostics

Why Pulse Biosciences’ 12-month nsPFA data matters in a PFA market dominated by Farapulse and Affera

Boston Scientific owns the PFA market. Pulse Biosciences just posted 90% one-year AF freedom. Is nanosecond PFA a real disruption or an acquisition target?

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Representative image of a mechanical thrombectomy procedure, illustrating the type of advanced vascular intervention technologies that Boston Scientific aims to scale through its planned $14.5 billion acquisition of Penumbra.
Medical Devices & Diagnostics

What Boston Scientific’s $14.5bn Penumbra buyout means for stroke and clot intervention markets

Boston Scientific Corporation has announced a definitive agreement to acquire Penumbra, Inc. for approximately $14.5 billion, marking one of its largest acquisitions to date in the medical device sector. The deal, structured as approximately 73 percent cash and 27 percent stock, offers Penumbra shareholders $374 per share and is expected to close in 2026, subject

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