RapidPulse, Inc. has initiated patient enrollment in an Investigational Device Exemption (IDE) study for its cyclic aspiration system designed to treat acute ischemic stroke (AIS). The RapidPulse® system is being utilized in a trial across multiple hospitals in Barcelona, Spain, aiming to improve first-pass clot removal success rates. This study expands to up to 30 hospitals in the U.S. and Europe, marking the first time U.S. doctors will have access to this technology.
This trial is a significant advancement in stroke treatment. Current clot removal devices often fall short of achieving complete reperfusion on the first attempt, which is crucial for minimizing patient mortality and morbidity. The RapidPulse system has demonstrated promising results in earlier studies, boasting first-pass full reperfusion rates significantly higher than existing devices. Successful implementation of this technology could drastically improve patient outcomes, potentially reducing long-term disability and the substantial costs associated with prolonged hospital stays and post-stroke care.
The RapidPulse system employs a proprietary, precisely pulsed aspiration algorithm designed to enhance clot removal efficiency. Previous studies have shown improvements in first-pass TICI scores (a measure of blood flow restoration) and significant increases in first-pass clot removal rates when compared to static aspiration techniques. Following completion of the IDE study, the collected data will be submitted to the FDA for 510(k) clearance, paving the way for commercialization in the U.S. market.
The initiation of this IDE study marks a critical step towards potentially revolutionizing acute ischemic stroke treatment. Positive results from this trial could lead to a paradigm shift in stroke intervention, offering a more effective and efficient method for clot removal. This, in turn, could translate to improved patient outcomes, reduced healthcare costs, and a significant advancement in the field of neurovascular intervention.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
