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Study Investigators Conclude RapidPulse™ Precise Cyclic Aspiration Is Highly Effective and Safe for Ischemic Stroke Large Vessel Occlusions

MIAMI, April 04, 2024 (GLOBE NEWSWIRE) — A study recently published on-line at Interventional Neuroradiology provided results from a multi-center trial giving promise to the use of precise cyclic aspiration in acute ischemic stroke (AIS). Researchers compared their ability to restore blood flow in AIS patients using standard (also known as static) aspiration to an innovative, patented, new technology from RapidPulse which precisely cycles aspiration to increase the removal rate of blood clots in the brain. In the U.S. alone, an estimated 700,000 strokes occur when a clot stops oxygenated blood flow to a portion of the brain.1

RapidPulse, Inc., a Miami, FL start-up focused on improving the treatment success rate for AIS, sponsored the study with enrollment of patients in Turkey, Brazil, Spain, Latvia, and Denmark. RapidPulse is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

In this study, 40 patients were enrolled in the RapidPulse arm and treated using an 0.071-inch catheter. Five of those patients were excluded from the per protocol analysis because they did not meet all the eligibility criteria. A control arm of 40 patients comprised of patients who met all the inclusion and exclusion criteria and had been treated within 12 months of the initiation of the study was used for comparative data. The investigators used commercially available aspiration catheters ranging in size from 0.070 to 0.072 to treat the control arm patients with standard aspiration pumps. The purpose of the study was to compare the percentage of patients who achieved almost complete (2c) or complete (3) reperfusion on the first aspiration attempt using the modified Thrombolysis in Cerebral Infarction (mTICI) scale.

In this study, the rate of mTICI≥2c after the first pass was 60.0% among the RapidPulse treated patients who met all eligibility criteria versus 38.5% in the corresponding control arm. This greater than 21-point improvement in their first pass clot removal rate led the authors to conclude the RapidPulse™ system is “highly effective and safe for the removal of large vessel occlusions.”2

The RapidPulse™ technology used in this study was comprised of an external valve box connected to a commercially available aspiration pump. This valve box was programmed to deliver a precise cyclic algorithm to the distal tip of the catheter where it can have maximal effect on clot removal. Future studies of a new version of the RapidPulse™ technology are expected to begin enrolling patients in 2024.

Dr. Serdar Geyik from Istanbul’s Aydin University commented, “This is an exciting improvement for the treatment of ischemic stroke due to large vessel occlusion. Higher recanalization rates on the first attempt are correlated with better outcomes for patients. This cyclic aspiration technology enabled fast and remarkable rates of excellent first pass recanalization rates. This may lead to reduced use of stent retrievers.”

“The control arm patients in this study had first pass mTICI scores consistent with the published data of other recent studies on standard aspiration. Through our extensive development work, we know high success rates are dependent upon the algorithm’s precision and how it is translated through the catheter to the clot,” said Sean McBrayer, CEO of RapidPulse. “Our system is made to allow stroke teams to quickly and easily achieve clot removal so they have the best chance of restoring reperfusion on the first pass,” he added.

The RapidPulse Feasibility Study is registered online at www.clinicaltrials.gov. The FDA has not yet reviewed nor cleared the RapidPulse aspiration system for commercialization and it is not commercially available for sale in the U.S. or other markets at this time.

Learn more about RapidPulse at https://rapidpulsemed.com/

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