{"id":45727,"date":"2022-07-01T01:01:55","date_gmt":"2022-06-30T23:01:55","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/neurovasc-technologies-announces-first-patient-treated-in-clinical-trial-to-evaluate-its-novel-stent-retriever\/"},"modified":"2022-07-01T01:01:55","modified_gmt":"2022-06-30T23:01:55","slug":"neurovasc-technologies-announces-first-patient-treated-in-clinical-trial-to-evaluate-its-novel-stent-retriever","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/neurovasc-technologies-announces-first-patient-treated-in-clinical-trial-to-evaluate-its-novel-stent-retriever\/","title":{"rendered":"NeuroVasc Technologies Announces First Patient Treated in Clinical Trial to Evaluate Its Novel Stent-Retriever"},"content":{"rendered":"
\n

IRVINE, Calif.–(BUSINESS WIRE)–NeuroVasc Technologies, Inc.<\/a> today announced that the first patient has been treated in its US IDE Clinical Trial, ENVI RCT \u2013 NeuroVasc Envi\u2122-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke. This trial will evaluate the safety and efficacy of the NeuroVasc ENVI\u2122-SR, a stent-retriever intended for the treatment of acute ischemic stroke to reduce disability by removing blood clots in patients with stroke due to large vessel occlusion.\n<\/p>\n

<\/a><\/p>\n

\n\u201cBy enrolling this first patient in this trial, we\u2019re taking an important step toward building evidence to support the clinical use of this novel, next generation stroke device,\u201d shared Vitor Mendes Pereira, MD, a neurosurgeon with St. Michael\u2019s Hospital, University of Toronto, who is a co-Principal Investor along with Raul Nogueira, MD, director of the University of Pittsburgh Medical Center (UPMC) Stroke Institute and professor of neurology at UPMC.\n<\/p>\n

\nThe study is a prospective, multinational, randomized, parallel group-controlled, blinded, non-inferiority trial to examine and compare clinical outcomes of patients being treated for acute ischemic stroke, as measured by Modified Rankin Scale (mRS) at 90 days post treatment, and related performance characteristics of the NeuroVasc ENVI\u2122-SR and concurrent parallel Control Devices currently cleared by the U.S. FDA for treatment of ischemic stroke.\n<\/p>\n

\n\u201cWe are very proud to be participating in such trials to further advance the treatment we can offer to our patients,\u201d said Nima Amin Aghaebrahim, MD, interventional neurologist and primary stroke director at Baptist Stroke & Cerebrovascular Center in Jacksonville, Florida, who performed the procedure.\n<\/p>\n

\nThe study will compare the next generation NeuroVasc ENVI\u2122-SR with the Solitaire\u2122 (Medtronic) and Trevo\u00ae (Stryker) product families.\n<\/p>\n

\n\u201cPartnering with the neurointerventional community in the U.S. offers us a great opportunity to investigate our novel technology with the view to improving the treatment of patients experiencing acute ischemic stroke around the world. We are proud of the NeuroVasc team in reaching this milestone,\u201d said Michael Losordo, NeuroVasc chief operating officer.\n<\/p>\n

\nAs populations age, the number of strokes is also on the rise. According to the World Health Organization, stroke is the second leading cause of death worldwide. An acute ischemic stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. When that happens, brain cells begin to die in minutes and prompt treatment is crucial. Early action can reduce brain damage and potential outcomes such as physical disability and death.\n<\/p>\n

\n\u201cWe are glad to get started on another landmark study, helping to bring new technology to our region and country,\u201d said Ricardo Hanel, MD, PhD, neurosurgeon and co-medical director of Baptist Stroke & Cerebrovascular Center.\n<\/p>\n

\nThe results of the study will support an application to the U.S. FDA for clearance of the NeuroVasc ENVI\u2122-SR device in the US, further expanding our commercial footprint and providing a strong foundation for NeuroVasc\u2019s future pipeline of game-changing neurovascular technologies.\n<\/p>\n

\nAbout the ENVI RCT \u2013 NeuroVasc Envi\u2122-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke
\n
<\/b>The ENVI RCT trial is the first prospective clinical trial in Ischemic Stroke which is an international, multicenter, randomized, controlled clinical trial to assess the effectiveness and safety of the NeuroVasc Envi\u2122-SR mechanical thrombectomy device for the restoration of blood flow in ischemic stroke. The trial is planned to enroll approximately 560 subjects in about 30 clinical centers across the US, Canada, and Europe. The study is being overseen by Vastrax, Inc., the world\u2019s leading full-service vascular clinical research organization (CRO).\n<\/p>\n

\nAbout the NeuroVasc ENVI\u2122-SR
\n
<\/b>The NeuroVasc ENVI\u2122-SR is a next generation clot retrieval device for use in patients experiencing acute ischemic stroke. NeuroVasc ENVI\u2122-SR was developed from the start as a stent-retriever, and the unique articulating segmental design allows the device to remain open under tension. The NeuroVasc ENVI\u2122-SR was developed with the support of physicians from Canada, China, Japan, France, the United Kingdom, and the United States. It has received CE Mark and is currently under investigation in China. The NeuroVasc Envi\u2122-SR is an investigational device, limited by federal (or United States) law to investigational use.\n<\/p>\n

\nAbout NeuroVasc
\n
<\/b>NeuroVasc Technologies, Inc. is a privately held company, founded in 2015, dedicated to advancing neurovascular innovation. Unlike other startups, NeuroVasc\u2019s objective is to assemble a leading catalog of products\u2014internally developed and acquired\u2014to address unmet needs in the treatment of neurovascular disease. Its current core products are the next-generation mechanical thrombectomy device that is under study in this IDE, a line of aspiration catheters, and an extensive line of access products, all carrying CE Mark. These products are investigational or pending FDA Clearance and are not available for sale in the United States.\n<\/p>\n

\nFor more information visit the company\u2019s website at www.neurovasctechnologies.com<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMichael Losordo
\n
info@neurovasctechnologies.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

IRVINE, Calif.–(BUSINESS WIRE)–NeuroVasc Technologies, Inc. today announced that the first patient has been treated in its US IDE Clinical Trial, ENVI RCT \u2013 NeuroVasc Envi\u2122-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke. This trial will evaluate the safety and efficacy of the NeuroVasc ENVI\u2122-SR, a stent-retriever intended for the treatment of acute ischemic … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45727","6":"format-standard","7":"category-industry"},"yoast_head":"\nNeuroVasc Technologies Announces First Patient Treated in Clinical Trial to Evaluate Its Novel Stent-Retriever - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/neurovasc-technologies-announces-first-patient-treated-in-clinical-trial-to-evaluate-its-novel-stent-retriever\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NeuroVasc Technologies Announces First Patient Treated in Clinical Trial to Evaluate Its Novel Stent-Retriever - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"IRVINE, Calif.–(BUSINESS WIRE)–NeuroVasc Technologies, Inc. today announced that the first patient has been treated in its US IDE Clinical Trial, ENVI RCT \u2013 NeuroVasc Envi\u2122-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke. 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