MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) -- RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS) announced that the United States Food and Drug Administration (FDA) agreed that RapidPulse can begin enrollment in an Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow U.S. and European patient enrollment in 2025 to commence in a study designed to demonstrate the RapidPulse patented method of precisely pulsed aspiration is safe and effective in the treatment of AIS. RapidPulse’s technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.
The RapidPulse® system which will be used in the IDE study was recently trialed in nineteen LVO patients enrolled at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asuncion in Paraguay and Istanbul Aydin Universitesi in Turkey. “Using the new RapidPulse® system, we achieved a 68% first pass effect of TICI 2c or better. This means almost 7 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,” stated Serdar Geyik, M.D. the lead investigator in Istanbul.
The RapidPulse Pivotal Study is targeted to enroll approximately 170 patients with recent onset of symptoms indicative of large vessel occlusion (LVO) in AIS. 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
Previously FDA-cleared devices for the treatment of stroke use either static aspiration, a stent retriever, or a combination of the two. However, most published studies have shown these currently available technologies only achieve complete or near complete reperfusion on the first attempt in approximately 4 out of 10 patients. RapidPulse is the first company to patent a system that 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.
RapidPulse has developed a complete system including a proprietary console to deliver precise, pulsed aspiration, highly trackable catheters, and a smart tubing set which ensures RapidPulse’s proprietary cyclic algorithm is tuned to each catheter size. “Through our extensive development work, we know the algorithm’s precision and how it is translated through the catheter to the clot face is critical to high success rates,” said Sean McBrayer, CEO of RapidPulse. “Our system is made to allow stroke teams to quickly and easily get a really powerful tool for clot removal to the right location so they have the best chance of restoring full reperfusion on the first pass.”
A prior study with the RapidPulse® system demonstrated physicians were able to achieve a 21-point improvement in their first pass clot removal rate when compared to contemporary patients who were treated with just static aspiration.4
Institutional Review Board approvals must be obtained prior to initiating enrollment at the investigational sites. 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. More information on the RapidPulse Pivotal Study endpoints and participating hospital systems can be found at www.clinicaltrials.gov.
Learn more about RapidPulse at https://rapidpulsemed.com/
MEDIA CONTACT:
Doug Ladd, info@rapidpulsemed.com, 305-266-3388
- https://www.cdc.gov/stroke/facts.htm
- Zaidat, Osama O., et al. “First pass effect: a new measure for stroke thrombectomy devices.” Stroke 49,3 (2018): 660-666.
- 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
- Bajrami, A., et al. “RapidPulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions.” Interventional Neuroradiology. March 2024. doi:10.1177/15910199241239094
