April 7, 2020
Enrollment Completed Early for TIGER Study of Rapid Medical's Tigertriever Thrombectomy Device
April 7, 2020—Rapid Medical, an Israel-based developer of next-generation neurovascular interventional devices, announced that it has completed enrollment ahead of schedule in the TIGER study, which is evaluating the performance of the company's Tigertriever 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. The device has received CE Mark approval and is commercially available in Europe. In the United States, the Tigertriever is an investigational device and is not available for sale, advised the company.
TIGER (Treatment with Intent to Generate Endovascular Reperfusion) is an investigational device exemption study of the safety and effectiveness of Rapid Medical's Tigertriever for treatment of ischemic brain stroke. The multicenter study was conducted at 16 stroke centers in the United States and one center in Israel. The study results will be used as part of the company's 510(k) submission of the device for FDA clearance.
The principal investigators for the TIGER study are vascular neurologist, Jeffrey Saver MD, and neurointerventionist, Rishi Gupta MD. Dr. Saver is Stroke Neurology Director at Ronald-Reagan-UCLA Medical Center in Los Angeles, California. Dr. Gupta is Director, Neurocritical Care at WellStar Health System in Marietta, Georgia.
In the company's press release, Dr. Saver commented, "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."
Dr. Gupta added, "The Tigertriever is a new-generation stentriever that 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."