16:29 uur 24-03-2021

TIGER-onderzoek toont hoge veiligheid en werkzaamheid aan voor het eerste instelbare trombectomie-apparaat ter wereld

De TIGERTRIEVER™ van Rapid Medical brengt stent retriever technologie vooruit voor de behandeling van een beroerte

YOKNEAM, Israël & MIAMI– (BUSINESS WIRE) – De eerste verstelbare, volledig zichtbare stent retriever toont superioriteit ten opzichte van conventionele stent retrievers in een multicenter-onderzoek. De meest recente resultaten werden onlangs gepresenteerd op de International Stroke Conference en online gepubliceerd in het tijdschrift Stroke. Het TIGER-onderzoek toont een statistisch significante verbetering van 11 punten aan in het vermogen om de bloedstroom naar de hersenen te herstellen tijdens ischemische beroerte en gelijkwaardige veiligheid voor het TIGERTRIEVER™ -apparaat in vergelijking met bestaande zelf expanderende stent retrievers.

“Het onderzoek bevestigde dat de TIGERTRIEVER niet alleen veilig en effectief is, maar ook aantoonbaar verbeterde resultaten ten opzichte van vergelijkbare onderzoeken waarbij eerdere technologie werd getest”, aldus Jeffery Saver, MD, FAHA, hoogleraar neurologie en directeur van het Comprehensive Stroke en Vascular Neurology Program aan de UCLA. “TIGERTRIEVER is een belangrijke stap vooruit in de behandelingsapparatuur voor beroertes en een overwinning voor patiënten.”

TIGER Trial Demonstrates High Safety and Efficacy for World’s First Adjustable Thrombectomy Device

Rapid Medical’s TIGERTRIEVER™ advances stent retriever technology for stroke treatment

YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)– The first adjustable, fully visible stent retriever shows superiority over conventional stent retrievers in a multicenter trial. The late breaking results were recently presented at the International Stroke Conference and published online in the journal Stroke. The TIGER Trial demonstrates a statistically significant 11-point improvement in the ability to restore blood flow to the brain during ischemic stroke and equivalent safety for the TIGERTRIEVER™ device compared to existing self-expanding stent retrievers.

“The trial confirmed that the TIGERTRIEVER is not only safe and effective, but demonstrably improved outcomes over similar trials testing previous technology,” observed Jeffery Saver, MD, FAHA, Professor of Neurology and Director of the Comprehensive Stroke and Vascular Neurology Program at UCLA. “TIGERTRIEVER is an important advance in stroke treatment devices and a win for patients.”

Stent retriever devices (“stentrievers”) are the gold standard in treating large vessel ischemic strokes. Delivered minimally invasively through the vasculature, they expand into the clot to capture and remove the blockage as the device is retrieved. Prior to TIGERTRIEVER, the diameter and force of these devices were non-adjustable. With TIGERTRIEVER, physicians control the diameter and force as needed in response to real-time anatomical and procedural information. This ability to respond to situational feedback is known as intelligent control. The TIGER Trial concludes that these improvements provide meaningful benefit when removing the clot and treating stroke.

The TIGER Trial ended early after overwhelming effectiveness with 160 patients enrolled at 17 centers in the US and Israel. The trial demonstrates 84.6% revascularization success, compared to a 73.4% average from 6 recent pivotal stent retriever trials. This improvement translates to significantly better patient outcomes, with 58% of patients living independently after 90 days versus an average of 43% of patients from the previous device trials. Additionally, the TIGER Trial shows improved safety, with an 18.1% primary safety score versus a 20.4% historical average.

“TIGERTRIEVER’s intelligent control represents a new generation of stent retrievers as shown by the highest revascularization success rate of similar stent retriever trials,” said Walid Haddad, Chief Clinical Officer at Rapid Medical. “We applaud the work performed by our national principal investigators, Drs. Jeffery Saver of UCLA and Rishi Gupta of Wellstar Health System in Atlanta, GA, and all of our investigators and clinical site staff.”

About Rapid Medical

Rapid Medical develops the premier responsive interventional devices for neurovascular diseases such as ischemic and hemorrhagic stroke. Utilizing novel manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the intravascular environment and have greater control over procedural outcomes. TIGERTRIEVER™, COMANECI™ and COLUMBUS™/DRIVEWIRE are CE marked. COMANECI™ and DRIVEWIRE are also FDA approved. More information is available at www.rapid-medical.com.

Contacts

Ronen Eckhouse

+972-72-2503331

ronen@rapid-medical.com

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