RapidPulse Announces Patient Enrollment Initiated in Pivotal Ischemic Stroke Study

/EIN News/ -- MIAMI, May 06, 2025 (GLOBE NEWSWIRE) -- RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS), announced patient enrollment has started in the Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. Researchers at Vall d’Hebron University Hospital, Bellvitge University Hospital, and Germans Trias i Pujols University Hospital in Barcelona Spain have begun using the patented RapidPulse^® system as part of the trial.

In the U.S. alone, each year an estimated 700,000 strokes occur when a clot blocks blood flow to the brain.¹ Prior studies have shown patients have lower rates or mortality and morbidity when clinicians can fully restore blood flow on the first attempt at clot removal.² Better clot removal rates also reduce the hospital length of stay and overall healthcare system costs.³

Up to 30 hospitals across the U.S. and Europe will enroll patients in this study designed to demonstrate the RapidPulse^® system, which uses precisely pulsed aspiration, is safe and effective in the treatment of AIS. More information on the RapidPulse Pivotal Study endpoints and participating hospital systems can be found at www.clinicaltrials.gov. Upon completion of the RapidPulse Pivotal Study, the data will be submitted to the FDA in consideration for receiving 510(k) clearance to market the device.

“Across three studies evaluating this novel technology, operators achieved first-pass full reperfusion rates ranging from 60% to 69%—a substantial improvement over the 40% to 42% rates typically observed with current-generation devices,” said Marc Ribo, M.D. Professor of Neurology at Vall d’Hebron University Hospital.

A study completed in 2024 and presented at the annual meeting of the recent Society of Vascular and Interventional Neurology demonstrated the RapidPulse^® system enabled researchers to get a first pass TICI score of 2c or higher in 68% of patients. A previously published study showed physicians using the RapidPulse^® system were able to achieve a 21-point improvement in their first pass clot removal rate, moving from 38.5% using static aspiration to 60% by using the new technology.⁴

“The intelligent patented technology imbedded in the RapidPulse^® system delivers a precise and proprietary aspiration algorithm,” Sean McBrayer, CEO of RapidPulse noted. “This IDE study is groundbreaking because it is the first time doctors in the U.S. will be able to employ a highly effective and easy-to-use aspiration system that intelligently modulates the vacuum energy being used to remove blood clots. We believe this IDE study will show our unique and proprietary method of removing clot will lead to a shift in the way doctors treat AIS in the future.”

The RapidPulse^® technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits. Other investors in RapidPulse include Santé Ventures, Hatteras Venture Partners, Epidarex Capital, and Broadview Ventures.

Learn more about RapidPulse at https://rapidpulsemed.com/
Learn more about Santé Ventures at https://sante.com/
Learn more about Hatteras Venture Partners at https://www.hatterasvp.com/
Learn more about Epidarex Capital at https://epidarex.com/
Learn more about Broadview Ventures at https://broadviewventures.org/
Learn more about Syntheon at https://www.syntheon.com/

MEDIA CONTACT:
Doug Ladd, info@rapidpulsemed.com, 305-266-3388

1. https://www.cdc.gov/stroke/facts.htm
2. Zaidat, Osama O., et al. "First pass effect: a new measure for stroke thrombectomy devices." Stroke 49,3 (2018): 660-666.
3. Dawson, Jesse et al. “Association between disability measures and healthcare costs after initial treatment for acute stroke.” Stroke 38,6 (2007): 1893-8. doi:10.1161/STROKEAHA.106.472381
4. Bajrami, A., et al. “RapidPulse™ cyclic aspiration system for acute ischemic stroke due to large vessel occlusions.” Interventional Neuroradiology. March 2024. doi:10.1177/15910199241239094