RapidPulse Receives IDE Approval for Pivotal Study of Its Cyclic Aspiration System for Ischemic Stroke

December 11, 2024—RapidPulse, Inc. announced FDA approval of an investigational device exemption (IDE) for the company to study the RapidPulse cyclic aspiration system in the treatment of acute ischemic stroke (AIS).

Patient enrollment in the RapidPulse pivotal study in the United States and Europe is anticipated in 2025. The study is expected to enroll approximately 170 patients with recent onset of symptoms indicative of large vessel occlusion (LVO) in AIS, and its data will be submitted to the FDA for consideration to receive 510(k) clearance.

The company noted that the RapidPulse system was recently studied in 19 patients with LVO who were enrolled at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción, in Asunción, Paraguay, and Istanbul Aydin Üniversitesi in Istanbul, Turkey.

Serdar Geyik, MD, the lead investigator in Istanbul, discussed the study findings in the company’s press release.

“Using the new RapidPulse system, we achieved a 68% first-pass effect of TICI 2c or better,” commented Dr. Geyik. “This means almost seven out of 10 AIS patients had near perfect or perfect reperfusion after one attempt. We were just as impressed that the RapidPulse catheter is as navigable as the benchmark catheters on the market and that 100% of patients achieved TICI 2b or higher within three passes.”

The company stated that the RapidPulse system rapidly cycles aspiration and is designed to improve the rate of full clot ingestion with higher reperfusion rates on the first pass and demonstrate impressive results when up to three passes are made. The RapidPulse technology is a spin-out of Syntheon 2.0, LLC, a medical device incubator.