Rapid Medical Receives FDA Clearance For The First Adjustable Stent Retriever For Use In Ischemic Stroke Treatment

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Rapid Medical’s TIGERTRIEVER provides a better grip on clots during stroke treatment, as shown by the pivotal TIGER Trial. (Photo: Business Wire)

Ronen Eckhouse, Rapid Medical Co-founder and CEO states, “The FDA clearance of TIGERTRIEVER is a significant milestone in the development and growth of Rapid’s global business. It is a great testament to the advantages of our proprietary 3D braiding technology–the platform for our portfolio of remotely adjustable neurovascular devices, including the Comaneci and Columbus products.”

Existing stent retrievers are non-adjustable, passive devices, delivered to the occlusion minimally invasively through the vasculature. When unconfined, they slowly expand into the blood clot. The blockage is hopefully captured and removed as the device is retrieved. Though currently recognized as the gold standard in treating large vessel ischemic stroke, traditional stent retrievers have significant limitations. They cannot be adjusted for patient variability and fail in about 30% of revascularization procedures.

TIGERTRIEVER provides physicians with intelligent control during thrombectomy procedures. With full device visibility and adjustability, physicians adapt their approach to visual and tactile feedback as needed. The benefit of this tailored approach to ischemic stroke patients was proven in the recently published TIGER Trial.

XNUMXD덴탈의 TIGER 시험 is a 160-patient pivotal trial to support FDA clearance, performed at 16 US Stroke Centers and 1 Israeli hospital. The study documents TIGERTRIEVER’s superiority over conventional stent retrievers, achieving a statistically significant improvement in the ability to restore blood flow to the brain and excellent comparable safety metrics. The trial also reveals the lowest-ever rate of clot fragmentation, suggesting that TIGERTREIVER’s control may provide better retention of the entire clot and minimize the potential for additional strokes caused by embolic particles.

“In the TIGER Trial, we saw an 11-point improvement in revascularization with TIGERTRIEVER over the data from recent stent retriever trials. This may improve outcomes for 1 in 10 stroke patients, a major leap from previous devices,” stated Dr. Rishi Gupta, national co-principal investigator of the TIGER Trial, vascular neurologist and Director of Neurocritical Care at WellStar Health System in Marietta, GA. “I have more control over the clot when I need it,” added Dr. Gupta.

TIGERTRIEVER is available in the USA in 21 mm and 17 mm sizes, applicable for a wide range large vessel occlusions.

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빠른 의료 허혈성 및 출혈성 뇌졸중과 같은 신경혈관 질환에 대한 최고의 응답성 중재 장치를 개발합니다. 새로운 제조 기술을 활용하는 Rapid Medical의 제품은 원격으로 조정 가능하고 완전히 눈에 보입니다. 이를 통해 의사는 혈관 내 환경에 실시간으로 대응하고 시술 결과를 더 효과적으로 제어할 수 있습니다. 타이거트리버™, 코마네치™ 및 COLUMBUS™/드라이브와이어 are CE marked. COMANECI™ and DRIVEWIRE are also FDA approved. More information is available at www.rapid-medical.com.