FDA Clears Rapid Medical’s Adjustable Tigertriever for Ischemic Stroke Treatment

March 25, 2021—Rapid Medical announced FDA clearance of the company’s Tigertriever revascularization device for use in the treatment of ischemic stroke. In the United States, Tigertriever is available in 21-and 17-mm sizes and is applicable for a wide range of large vessel occlusions.

Rapid Medical stated that the Tigertriever offers intelligent control during thrombectomy procedures, enabling neurointerventionalists to better remove blood clots and restore blood flow to the brain after an ischemic event. With full device visibility and adjustability, physicians adapt their approach to visual and tactile feedback as needed.

According to the company, the benefit of this tailored approach to ischemic stroke patients was demonstrated in the TIGER trial, a 160-patient pivotal trial to support FDA clearance that was performed at 16 United States stroke centers and one Israeli hospital.

On March 24, the company announced that the TIGER findings were presented at the American Stroke Association’s International Stroke Conference 2021, held virtually March 17-19, 2021. The study was also published by Rishi Gupta, MD, et al online in Stroke. Dr. Gupta and Jeffery L. Saver, MD, served as Principal Investigators of the TIGER trial.

The company reported that the trial achieved a statistically significant improvement in the ability to restore blood flow to the brain and excellent comparable safety metrics. Additionally, the trial’s low rate of clot fragmentation suggests that Tigertriever’s control may provide better retention of the entire clot and minimize the potential for additional strokes caused by embolic particles.

“In the TIGER trial, we saw an 11-point improvement in revascularization with Tigertriever over the data from recent stent retriever trials,” commented Dr. Gupta in Rapid Medical’s press release. “This may improve outcomes for one in 10 stroke patients, a major leap from previous devices. I have more control over the clot when I need it.” Dr. Gupta is a vascular neurologist and Director of Neurocritical Care at WellStar Health System in Marietta, Georgia.