Data from the study will be submitted to the FDA in support of Market Clearance for TIGERTRIEVER in the U.S.
Rapid Medical, an Israeli company focused on the development of next generation neurovascular interventional devices, has announced that the first patients have been enrolled in the TIGER (Treatment with Intent to Generate Reperfusion) study.
This is a multi-centre study of the performance of TIGERTRIEVER, the company’s novel thrombectomy device for the acute treatment of ischemic stroke.
The TIGER study is an IDE clinical study for purposes of supporting the company’s 510(k) submission to the U.S. Food and Drug Administration to obtain clearance to market the device in the U.S. The study will take place in up to 25 of the leading stroke centers throughout the U.S.. Neurologists, Jeff Saver M.D. , UCLA Medical centre in Los Angeles, California, and Rishi Gupta M.D., Director, Neurocritical Care at WellStar Health System, Georgia, are the principal investigators of the study.
More than a thousand patients have been commercially treated with the TIGERTRIEVER in Europe, and it is the subject of a post-marketing registry in several European countries. The TIGERTRIEVER is a superior, fully-visible, controllable stentriever that is adjusted to perfectly fit the dimensions of a blocked blood vessel causing acute ischemic stroke.
These initial cases were performed by Dr. Gupta and Dr. Ahmad Khaldi, the director of Cerebrovascular Neurosurgery at Wellstar Medical. “We are pleased to have enrolled the first patients and to have a leadership role in the TIGER study. Stentrievers are now the gold standard for treating ischemic stroke, and TIGERTRIEVER is a new generation stentriever. Its unique design will hopefully show that it addresses the limitations of current devices and will improve patient outcomes,” stated Dr. Gupta.