NY-RAPID-MEDICAL
Rapid Medical , a leading developer of advanced neurovascular devices, today announced FDA investigational device exemption (IDE) approval for the first-ever trial to expand interventional stroke treatment to distal regions of the brain. The DISTALS Study is a pivotal, international, multi-center, randomized controlled trial (RCT) to evaluate the safety and effectiveness of distal thrombectomy. This new frontier for ischemic stroke has been created by Rapid Medical’s development of TIGERTRIEVER™ 13 , the smallest thrombectomy device available.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211103005702/en/
“We're especially pleased to receive unprecedented FDA IDE approval for a study with DISTALs focus," elates Jeffrey Saver , MD, FAHA, Professor of Neurology and Director of the Comprehensive Stroke and Vascular Neurology Program at UCLA in Los Angeles, CA and principal investigator. "With the ever-growing benefits of mechanical thrombectomy, we hope to offer better recoveries to a much broader patient population. Rapid Medical has been at the forefront of enabling that progress."
Currently, less than 10% of ischemic stroke patients receive mechanical thrombectomy, a well-proven treatment that significantly improves patient outcomes. While Rapid Medical's TIGERTRIEVER 13 has already been used to treat nearly 1500 patients in Europe and the Middle East, the DISTALS Study aims to extend these benefits to an additional 25 – 40% of stroke patients. It focuses on far territories in the brain, such as M3 blood vessels, and allows intervention within 24 hours from symptoms onset.
"The DISTALS trial is critical for the field of interventional stroke therapy,” says David Fiorella , MD, PhD and Director of the Cerebrovascular Center at Stony Brook University Medical Center in Stony Brook, NY and co-coordinating investigator. "It potentially allows us to offer thrombectomy to an additional large group of stroke patients who may benefit substantially.”
Ronen Eckhouse , Co-Founder and CEO of Rapid Medical, says the company plans to start the study in Q421 or early Q122. "We announced this news on World Stroke Day to emphasize its significance. Effective treatment of distal stroke represents a leap forward–to diminishing the devastating effects of stroke."
The leading investigators also include René Chapot, MD, Professor and Department Head of Neuroradiology and Radiology at Alfried Krupp Krankenhaus in Essen, Germany, and Rishi Gupta, MD and Director of Neurocritical Care at Wellstar Health System in Marietta, GA.
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 ™17 and 21, COMANECI ™ and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER ™13 and XL are also CE marked. More information is available at www.rapid-medical.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211103005702/en/
Link:
About Business Wire
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
Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD7.1.2026 12:30:00 CET | Press release
FDA Accepts Investigational New Drug (IND) Application for COMP360 for the treatment of post-traumatic stress disorder (PTSD), enabling initiation of late-stage trialCompass continues to advance commercial preparations to be launch-ready by the end of the year for COMP360 for treatment-resistant depression (TRD)Management will host webinar with KOL and industry leaders to discuss PTSD clinical trial and commercial preparations for TRD from 10:00-11:30 am ET on January 7th Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD. Compass management, along with KOL and industry leaders, will host a webinar today to discuss the company’s clinical trial plans for PTSD, as well as commercial preparations f
Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.7.1.2026 11:07:00 CET | Press release
Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January. Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use. Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity. Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy,
ARIS Announces New CEO to Lead Agentic AI-led Strategy7.1.2026 10:00:00 CET | Press release
CEO Appointment ARIS, a global leader in process intelligence and transformation software, today announced the appointment of Guillaume Bacuvier as Chief Executive Officer. Guillaume will lead ARIS through its next phase of growth as a fully standalone company, accelerating its evolution from a market leader in Process Intelligence into a foundational platform for enterprises deploying and governing Agentic AI. Guillaume brings deep international leadership experience across technology, data, and software-enabled businesses, with a proven track record of scaling global platforms and leading complex organisations. After starting as a strategic consultant at Booz Allen Hamilton, Guillaume spent over a decade at Google, rising to Vice President in EMEA where he built and scaled some of Google’s largest data-driven businesses in Europe and held P&L responsibility across multiple countries. In the last decade, Guillaume has served as CEO of multi-continent, data-centric companies including
I Squared Capital Acquires Ramudden Global, a Leader in Traffic Management and Infrastructure Safety7.1.2026 09:00:00 CET | Press release
Acquisition will accelerate Ramudden’s ambitious growth plan across North America and Europe supported by strong infrastructure spending tailwinds I Squared Capital, a leading global infrastructure investment manager, today announced that, through its flagship fund, it has agreed to acquire Ramudden Global, from funds advised by Triton Partners (“Triton”), a leading European mid-market sector-specialist investor. Ramudden Global is a leading international provider of traffic management and infrastructure safety services supporting the maintenance and upgrade of essential transport and utility networks. The company operates more than 190 depots across 13 countries in Europe and North America delivering mission-critical services that help to ensure safety, regulatory compliance and continuity of service across road, utility and broader infrastructure works. This investment underscores I Squared Capital’s commitment to investing in essential, regulated, infrastructure businesses that unde
RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta7.1.2026 09:00:00 CET | Press release
RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease. Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life. BOOST Pharma was founded on pioneering science originating from Karolins
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