Rapid Medical Receives FDA Clearance for the First Adjustable Stent Retriever for Use in Ischemic Stroke Treatment
25.3.2021 19:02:00 EET | Business Wire | Press release
Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER™ revascularization device for use in the treatment of ischemic stroke. TIGERTRIEVER is the first stent retriever to offer intelligent control, enabling neuro interventionalists to better remove blood clots and restore blood flow the brain following an ischemic event—a condition that devastates 800,000 Americans annually. Already approved in Europe, over 5,000 patients have been treated with TIGERTRIEVER.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210325005722/en/
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.
The TIGER Trial 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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005722/en/
Contact information
Ronen Eckhouse
+972-72-2503331
ronen@rapid-medical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Airship Announces 2026 Elevate Customer Experience Award Winners4.5.2026 16:00:00 EEST | Press release
Airship, the mobile-first customer experience company, today announced the winners of the 2026 Elevate Customer Experience Awards. Global brand leaders from The Economist, Southwest Airlines, and OneFootball were among those honored at the Elevate’26 Customer Experience Summit. The Elevate Awards spotlight global companies that have developed exceptional mobile-first customer experiences for their customers, created innovative campaigns, leveraged AI agents to reach new levels of productivity, and achieved real business results. "Evolving mobile-first consumer behaviors and unprecedented advancements in AI are driving a seismic shift that is reshaping how brands interact with their customers," said Brett Caine, CEO, Airship. "The 2026 Elevate Award winners aren’t just adapting, they’re leading transformative and meaningful customer experiences. These leading organizations are turning everyday interactions into seamless, cross-channel journeys that deliver meaningful business impact and
Tigo Energy Breaks Global Growth Benchmark; Boosts U.S. Energy Feature in Predict+4.5.2026 16:00:00 EEST | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy solutions, today announced that the Predict+ platform now offers integrated real-time spot market pricing for ISO customers in the United States. Predict+ provides utilities with deep insights into grid demand, renewable generation, and energy market dynamics, enhancing the precision, scalability, and robustness of energy forecasting to up to 97.5% accuracy through machine learning and artificial intelligence. For energy providers, Predict+ helps streamline operations, reduce volatility, and maximize performance. Predict+ empowers utility operators to adapt to real-world demand challenges when balancing renewable and baseload generation sources, particularly during extreme weather events and market disruptions. On the demand side, with smart meter integration, Predict+ models each meter individually and performs extensive calculations on actual, historical, and average data to acc
Alnylam to Present New Analyses at Heart Failure 2026 Underscoring Consistent Clinical Profile of Vutrisiran in ATTR-CM4.5.2026 15:30:00 EEST | Press release
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it will present new data analyses for vutrisiran in patients with the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) at Heart Failure 2026, a scientific congress of the European Society of Cardiology, taking place May 9-12, 2026, in Barcelona, Spain. ATTR-CM is a heterogeneous and rapidly progressive disease, and patients often present with complex clinical profiles. At Heart Failure 2026, Alnylam will present multiple new analyses from the Phase 3 HELIOS-B study of vutrisiran, which continue to support its use as a first-line treatment for patients with ATTR-CM, and further characterize its clinical profile across patients with a high disease burden, and in the context of concomitant therapies. Vutrisiran is the first and only transthyretin (TTR) silencer for ATTR-CM that delivers rapid knockdown of TTR at the source. Additional analyses being pr
Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID)4.5.2026 15:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) today announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase]. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID). The TAK-881-3001 clinical trial ev
Ouster Releases The REV8 OS Family: The World’s First Native Color Lidar4.5.2026 13:00:00 EEST | Press release
Ouster, Inc. (Nasdaq: OUST) (“Ouster” or the “Company”), a leader in sensing and perception for Physical AI, announced today its new family of OS digital lidar sensors, Rev8, powered by its next-generation L4 Ouster Silicon. Ouster Rev8 features the world’s first patented native color lidar sensors, provides up to double the range and resolution of the previous generation, and is designed for functional safety, reliability, affordability, and scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260504718668/en/ The REV8 OS Family: The World's First Native Color Lidar. L4 Ouster Silicon: Ouster’s breakthrough L4 architecture doubles the range and resolution of its lidar over the prior generation, adds native-color sensing, and is designed for functional safety. Based on patented Ouster Silicon with embedded Fujifilm color science, the L4 chip results in exquisite color data and hardware-enabled HDR. It boasts 42.9 GMACs of p
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom