Rapid Medical to Initiate the First-Ever Trial to Expand Stroke Treatment to Distal Regions of the Brain–Offering Thrombectomy Treatment to New Patient Population
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/
TIGERTRIEVER™ 13, the smallest clot retriever available, enables the first-ever clinical trial for distal ischemic stroke intervention. The device uniquely allows physicians to control the device diameter for greater precision in these procedures.
“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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
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
Nel ASA: Receives Purchase Order for 20MW Alkaline Electrolyser From Ovako26.11.2021 22:45:00 EET | Press release
Nel Hydrogen Electrolyser AS, a division of Nel ASA (Nel, OSE:NEL), has received a purchase order for a 20MW alkaline water electrolyser from Ovako, a leading European manufacturer of engineering steel. The electrolyser will be installed at Ovako’s existing plant in Hofors, Sweden. The fossil-free hydrogen will replace the use of fossil propane gas currently used in the heating furnaces. “We are excited to announce the delivery of electrolyser equipment to Ovako. There is huge potential in reducing CO2-emissions from steel-heating processes through green hydrogen. We look forward to working with Ovako and its partners to further develop fossil-free steel production,” says Jon André Løkke, CEO at Nel. The purchase order has a contract value of approximately EUR 11 million with equipment delivery in late 2022. The electrolyser will produce oxygen and hydrogen for Ovako’s steel-heating process and is a major step towards zero-carbon emission steel production. The conversion to hydrogen wi
'Afghan Girl' Sharbat Gula Safely Evacuated to Italy Via Efforts of Photographer Steve McCurry, Metagood/OnChainMonkey Crypto Community & Future Brilliance Charity26.11.2021 20:16:00 EET | Press release
The legendary 'Afghan Girl' photographer, Steve McCurry, and his sister, Bonnie McCurry, are delighted to announce that, together with the British-American charity, Future Brilliance, and with the support of the Italian government, and NFT for Social Good platform Metagood, they have been able to bring the famous icon for Afghan female refugees, Sharbat Gula, to safety. Background: Six weeks ago, Bonnie McCurry reached out to Future Brilliance founder, impact pioneer, and investor Sophia Swire who has a 30-year track record of empowering women in Afghanistan. She told Sophia that Sharbat Gula wanted to be evacuated with her family. After considering all the various country options, they confirmed with Sharbat that her family hoped to seek asylum in Italy. Sophia and her team activated the Future Brilliance network in Afghanistan and, together with the McCurry family, arranged the necessary paperwork, visas, and logistics. The NFT for good platform Metagood (who worked with McCurry to d
ZOVOO Held Distributor Conference, Creating a Splash of Colour in Atomization Industry26.11.2021 18:45:00 EET | Press release
At 9:30pm (GMT +8) on November 12, ZOVOO, a new industry-leading atomization company, held its 2021 distributor conference online. Distributors from United States, United Kingdom, France and other countries participated in the conference. Meanwhile, ZOVOO also displayed its newly developed disposable products DRAGBAR series for the first time to the public, which attracted widespread attention from distributors worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005521/en/ (Photo: Business Wire) Founded in 2010, ZOVOO has sophisticated research and develop capability, forward-looking product design and perfect supply chain system. ZOVOO founding team has 10 years of proven strength and experience. They have the absolute advantages in terms of heating materials, air channel structure design, etc., and build up the five criteria of good flavor. The birth of each product needs to go through from R&D, design, product
Indeed and Quandoo Announce Partnership to Support the Restaurant Industry Hiring Crisis26.11.2021 17:21:00 EET | Press release
Indeed, the world’s largest jobs site, and Quandoo, one of the fastest growing restaurant reservation platforms worldwide, today announce a partnership to support the restaurant industry's current hiring crisis. This partnership will see restaurants be provided with £50 credit to post a sponsored job advertisement on Indeed’s platform. Sponsored jobs advertisements receive optimal visibility and are more likely to deliver hires* which Indeed and Quandoo hope will connect staff with the restaurants that need them the most. Employers posting a job on Indeed for the first time will have £50 credited to their account to start sponsoring their jobs and reaching more candidates. Employers in the UK can claim the offer here . “We are so excited about this partnership. It’s a topic that is close to home for us at Quandoo as we are hearing how challenging it is to find staff from our partners. So we wanted to do our bit to support the wider industry in any way we can. By partnering with Indeed
The Leading Event for Payment, Identification and Security Professionals, TRUSTECH will present all the Latest trends in the sector26.11.2021 12:34:00 EET | Press release
For three days, professionals of the cards and digital trust technologies industries will meet at the TRUSTECH exhibition in Paris to discuss the issues and challenges of identity, security and payment, which are the real pillars of the digital transition for institutional or commercial organisations. A panel of international speakers will share their insights across the multiple conference sessions The 6,000 attendees expected from all over the world will also be able to discover concrete solutions to optimise their business and develop their practices. Visitors will have FREE access to participate at Trustech conferences program. AUTHENTICATION AND IDENTIFICATION: A STRATEGIC ISSUE FOR GOVERNMENTS AND ORGANISATIONS These new demands on governments require the use of increasingly complex technologies and processes. Digitization brings into question how the use of physical official documents will be used in the future. It also implies there will be new innovations regarding how physica
Vifor Pharma supports Iron Deficiency Day 2021: Call to action for early iron deficiency diagnosis26.11.2021 09:00:00 EET | Press release
Already for the seventh consecutive year of Iron Deficiency Day, Vifor Pharma is supporting a growing international alliance including the Heart Failure Policy Network, European Kidney Health Alliance, Global Heart Hub and Croí the West of Ireland Cardiac Foundation with the aim to educate people about the importance of iron for the body and what can happen if iron levels are not properly managed. Iron Deficiency Day 2021 encourages people at risk to listen to their body, to take iron seriously and to take control over their health by seeking early diagnosis and medical help from their physician. Iron Deficiency affects about half of the patients with chronic kidney disease2 and chronic heart failure and is associated with reduced quality of life3, an increased risk of hospitalization4 and cardiovascular death5. Despite the serious consequences and high prevalence, of iron deficiency, the condition remains under-recognized6. Diagnosis and treatment of iron deficiency has been further i
LightCON Unveils Global Teaser Site for New Mobile Game 'Rise of Stars (ROS)'26.11.2021 05:00:00 EET | Press release
Rise of Stars (ROS), a new mobile game that is being developed by LightCON, a subsidiary of WEMADE MAX (Co-CEOs: Hyunguk Chang, Gilhyung Lee) (KOSDAQ: 101730), today opened its global teaser site. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211125006252/en/ LightCON unveils global teaser site for new mobile game 'Rise of Stars (ROS).' ROS is a new mobile SF strategy game featuring elaborately designed warships and planets set in the vast universe. Under the slogan, 'The 4x Blockchain Game for the Greatest Conqueror,' the teaser site was designed to help users experience the unique atmosphere of ROS and the game concept with the representative image of the game. ROS will be building a system for players to obtain game tokens through resource mining within planets. It aims for a global launch in the 1st quarter of 2022. (Graphic: Business Wire) Under the slogan, ‘The 4x Blockchain Game for the Greatest Conqueror,’ the tease
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