<div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="206354432" paraeid="{8e664840-82c6-424d-be4e-afbb9b815fa7}{220}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Using the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboliner</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>system is safe and<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">feasible</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>in patients</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>with severe aortic stenosis (AS)</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>undergoing transcatheter aortic valve replacement (TAVR), according to results from the Protect<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW248344071 BCX0">The</span><span> </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW248344071 BCX0">Head to Head</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>study.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1930097382" paraeid="{7dff8112-b628-44c6-ab76-1ecb0c309262}{83}"><span class="NormalTextRun SCXW248344071 BCX0">These data were reported by Adam B. Greenbaum, MD, of Emory University Medical Center, Atlanta, on Sunday during a late-breaking clinical trial presentation at the American College of Cardiology (ACC) 2026 Scientific Sessions in New Orleans.</span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1784112052" paraeid="{6f2faae6-9d09-4adc-80b3-216815ddc6fc}{232}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Stroke is a rare, but major, TAVR complication. Currently available embolic protection devices (EPD) only<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">somewhat provide</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>protection for cerebral circulation, but this has room for improvement.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="509121344" paraeid="{b3eed6ab-0bdb-400e-8793-c8a31280b327}{237}"><span class="NormalTextRun SCXW248344071 BCX0">The investigators examined the use of the<span> </span></span><a class="Hyperlink SCXW248344071 BCX0" href="https://emboline.com/product/" target="_blank" rel="noreferrer noopener"><span class="NormalTextRun SCXW248344071 BCX0" data-ccp-charstyle="Hyperlink">Emboliner</span></a><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>(</span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboline</span><span class="NormalTextRun SCXW248344071 BCX0">) device for embo</span><span class="NormalTextRun SCXW248344071 BCX0">lic protection during TAVR. The Emboliner captures downstream debris and co</span><span class="NormalTextRun SCXW248344071 BCX0">mpletely covers the</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>aortic arch.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1604683152" paraeid="{8a3c0b54-bb2f-403b-98c2-93ae7a1b4282}{121}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">The open-label, multicenter, international Protect<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW248344071 BCX0">The</span><span> </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW248344071 BCX0">Head to Head</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>study, which took place across 20 sites in Brazil, Germany and the U.S., randomized patients 1:1 to receive the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboliner</span><span> </span><span class="NormalTextRun SCXW248344071 BCX0">device<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">or S</span><span class="NormalTextRun SCXW248344071 BCX0">ENTINEL</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>cerebral protection system (Boston Scientific). Patients were stratified according to self-expanding and balloon-expandable<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">bioprostheses</span><span class="NormalTextRun SCXW248344071 BCX0">.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="101188474" paraeid="{8d244c4c-063a-4b42-a573-da89f8a2438d}{198}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Major adverse cardiac and cerebrovascular events (MACCE), all-cause death,<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">stroke</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>and stage 3 acute kidney in</span><span class="NormalTextRun SCXW248344071 BCX0">jury at 30-days<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">comprised</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>the composite primary safety and efficacy endpoint for non-inferiority.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1117011876" paraeid="{954f7455-ec89-450f-90af-e830fa2a9c5f}{74}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">The secondary safety and efficacy endpoint was 30-day stroke for noninferiority, and the secondary efficacy endpoint was the number of particles captured (≥150</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>µm)<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">for superiority.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1235241562" paraeid="{bf563a69-7fee-4854-abce-074fe74d95f5}{218}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">A total of 258 patients received the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboliner</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>device (mean age=78.7 years, 34.7% women</span><span class="NormalTextRun SCXW248344071 BCX0">; 70.9% balloon-expandable TAVR and 29.1% self-expandable device TAVR</span><span class="NormalTextRun SCXW248344071 BCX0">) and 264 patients received the SENTINEL device (mean age=78.8 years, 31.8% women</span><span class="NormalTextRun SCXW248344071 BCX0">; 70.5% balloon-expandable TAVR and 29.5% self-expandable device TAVR</span><span class="NormalTextRun SCXW248344071 BCX0">) and were e</span><span class="NormalTextRun SCXW248344071 BCX0">valuated in this trial.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="903811750" paraeid="{8ce69c5b-0953-4f1c-b40f-33193768ed92}{166}"><span class="NormalTextRun SCXW248344071 BCX0">At 30-day follow-up, 4.5% of patients in the Emboliner group and 5.0% of patients in the SENTINEL group experience the primary endpoint (p for noninferiority=0.0004).</span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2040472822" paraeid="{393fe3ca-3531-4556-b9b5-6ddb27a3850e}{124}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Similar safety events and individual components of the primary endpoint were<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">observed</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>in both groups. However, the Emboliner device captured significantly more debris</span><span> </span><span class="NormalTextRun SCXW248344071 BCX0">≥150 µm<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">(n=93)</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>compar</span><span class="NormalTextRun SCXW248344071 BCX0">ed with the SENTINEL device<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">(n=31)<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">(p for superiority<0.0001).</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="739586974" paraeid="{c8279d44-182a-4ec7-84ed-22e2b4385a5d}{81}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Technical success and procedural success were also<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">accomplished</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>more in the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboliner</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>group (95.9% and 93.8%) compared with the SENTINEL group (87.1% and 8</span><span class="NormalTextRun SCXW248344071 BCX0">5.1%</span><span class="NormalTextRun SCXW248344071 BCX0">) (p=0.0005</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>and p=0.0018</span><span class="NormalTextRun SCXW248344071 BCX0">).</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1984977493" paraeid="{9ab51742-fd8e-4d57-ac0d-66be79390367}{93}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">“Emboliner is non-inferior to Sentinel in terms of 30-day safety and efficacy endpoints — composite MACCE and all<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW248344071 BCX0">stroke</span><span class="NormalTextRun SCXW248344071 BCX0">.<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW248344071 BCX0">Emboliner</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>is superior to Sentinel in terms of debris capture ≥150 µm,” Dr. Greenbaum said during his presentation.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1322842657" paraeid="{1b8ba9f6-22a3-476f-909d-15838d0e301a}{7}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">Key limitations included the fact that the study was powered for non-inferiority in routine<span> </span></span><span class="NormalTextRun SCXW248344071 BCX0">TAVR;</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>the study was not powered to detect treatment differences for individual MACCE or stroke, or downstream embolic events; and DW-MRI was not included.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="214162526" paraeid="{74d7045a-dcc2-4cf3-8df9-29d16283a985}{200}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW248344071 BCX0"><span class="NormalTextRun SCXW248344071 BCX0">“While the trial was not powered to detect differences in terms of other outcomes from debris elsewhere. Any embolic debris during TAVR is neutral at best, potentially harmful, and it would therefore be intuitive that<span> </span></span><span class="NormalTextRun AdvancedProofingIssueV2Themed SCXW248344071 BCX0">as long as</span><span class="NormalTextRun SCXW248344071 BCX0"><span> </span>the system is safe and easy to use, the more debris captured, the better,” Dr. Greenbaum said in a corresponding ACC press release.</span></span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW248344071 BCX0"> <p class="Paragraph SCXW248344071 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1018822870" paraeid="{8911abd8-15a6-4350-89ec-8f75c7c95ec9}{228}"><strong><span class="NormalTextRun SCXW248344071 BCX0">Image Credit: Screenshot by Bailey G. Salimes, CRTonline.org.</span><span class="EOP Selected SCXW248344071 BCX0" data-ccp-props="{}"> </span></strong></p> </div>