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
FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 17:10:00 CET | Press release
Multi-year Concorde Governance Agreement signed by the FIA, Formula 1 Group and all 11 teams, securing the World Championship through 2030 Paves the way for a more professionalised sport and represents a new era of collaboration between the FIA and Formula 1 Group Long-term commitment enhances sporting reliability, global reach and stability for teams, fans and broadcasters The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a m
Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 16:26:00 CET | Press release
Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject
Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 15:49:00 CET | Press release
The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.
Perma-Pipe International Holdings, Inc. Announces Third Quarter 2025 Financial Results12.12.2025 15:00:00 CET | Press release
Net sales of $61.1 million for the quarter and $155.8 million year-to-date.Income before income taxes of $10.9 million for the quarter and $21.1 million year-to-date.Diluted earnings per share of $0.77 for the quarter and $1.49 year-to-date.Backlog of $148.9 million at October 31, 2025, up from $138.1 million at January 31, 2025. Perma-Pipe International Holdings, Inc. (NASDAQ: PPIH) announced today financial results for the third quarter ended October 31, 2025. “For the three months ended October 31, 2025, net sales were $61.1 million, an increase of $19.5 million, or 46.9%, compared to $41.6 million in the same quarter of the prior year. Growth was driven by higher sales volumes in both the Middle East and North America. Gross profit was $21.0 million, up $6.9 million from $14.1 million last year, reflecting higher activity levels. Selling, general and administrative expenses increased to $8.3 million from $7.3 million, primarily due to higher payroll and professional fees, including
Capcom’s All-new IP PRAGMATA to Launch on April 24, 2026!12.12.2025 15:00:00 CET | Press release
– The title is now also coming to Nintendo Switch 2; a PC demo releases today – Capcom Co., Ltd. (TOKYO:9697) today announced that sci-fi action-adventure game PRAGMATA, a completely new IP, is scheduled for release on April 24, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212791950/en/ PRAGMATA Key Art PRAGMATA is a new type of sci-fi action-adventure game mixing puzzle and action elements. In the game, which takes place on the moon in a near-future world, the spacesuit-clad Hugh and android girl Diana cooperate while fighting their way back to Earth. By bringing the title to Nintendo Switch™ 2 in addition to PlayStation®5 system, Xbox Series X|S and PC, Capcom looks to further advance its multi-platform strategy and expand its user base. Moreover, a playable demo of the game will be released first on PC starting today, December 12, to further convey the appeal of the title. The company hopes that players look fo
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