Rapid Medical Announces Ahead of Schedule Completion of Patient Enrollment for the TIGER Clinical Study for TIGERTRIEVER Thrombectomy Device
YOKNEAM, Israel, April 7, 2020 /PRNewswire/ -- Rapid Medical, a company focused on the development of next generation neurovascular interventional devices, has announced that it has completed enrollment in the TIGER (Treatment with Intent to Generate Reperfusion) study ahead of the planned scheduled. This is a US based, multi-center study of the performance of TIGERTRIEVER, the company's novel thrombectomy device for the acute treatment of ischemic stroke. The TIGERTRIEVER is a fully-visible, controllable stentriever that is adjusted to fit the dimensions of a blocked blood vessel causing acute ischemic stroke. Vascular neurologist, Jeffrey Saver M.D., Stroke Neurology Director at Ronald-Reagan-UCLA Medical Center in Los Angeles, California, and neurointerventionalist Rishi Gupta M.D., Director, Neurocritical Care at WellStar Health System, Georgia, are the principal investigators of the study.
"It was our honor and pleasure to co-lead this trial and we would like to thank the patients, their families, and the clinical sites who participated in the study. Their dedication enabled rapid patient recruitment and trial completion ahead of schedule, despite the extra challenges of the current medical moment," said Prof. Saver.
"The TIGERTRIEVER is a new generation stentriever which provides the physician with enhanced user control. Its unique design will hopefully show that it addresses the limitations of current devices to provide optimal patient outcomes. We are looking forward to publishing the data," stated Dr. Gupta.
TIGER is a multi-site, IDE study evaluating the safety and effectiveness of Rapid's TIGERTRIEVER for treatment of ischemic brain stroke. The study results will be used as part of the 510K submission of the device for FDA clearance. The study was completed ahead of schedule and took place at 16 of the leading stroke centers throughout the U.S and one center in Israel. The TIGERTRIEVER device has CE mark clearance and is commercially available in Europe; thousands of ischemic stroke thrombectomy procedures are performed with the device every year.
About Rapid Medical Rapid Medical is developing game-changing devices for endovascular treatments. Rapid Medical is the maker of TIGERTRIEVER and COMANECI, the first-ever adjustable remodeling mesh. TIGERTRIEVER and COMANECI are CE marked for use in Europe and COMANECI is also FDA approved. The TIGERTRIEVER is an investigational device and is not available for sale in the United States.
More information is available at http://www.rapid-medical.com
Contact:
Eitan Havis,
VP of Sales and Marketing,
Rapid Medical
eitan@rapid-medical.com
+972-72-250-3331
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