RapidPulse, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the commencement of an Investigational Device Exemption (IDE) study for its innovative cyclic aspiration system, designed to improve treatment outcomes in acute ischemic stroke (AIS). The approval paves the way for patient enrollment in the U.S. and Europe, starting in 2025, to evaluate the safety and efficacy of the RapidPulse system.
The RapidPulse system employs a patented method of precisely pulsed aspiration, which aims to enhance clot removal rates and improve reperfusion in patients experiencing AIS due to large vessel occlusion (LVO). The technology is a spin-out of Syntheon 2.0, LLC, a medical device incubator.
Clinical Trial Results
In a recent trial involving nineteen LVO patients at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asuncion in Paraguay and Istanbul Aydin Universitesi in Turkey, the RapidPulse system demonstrated promising results. According to Serdar Geyik, M.D., the lead investigator in Istanbul, the system achieved a 68% first-pass effect of TICI 2c or better. This indicates that nearly 7 out of 10 AIS patients experienced near-perfect or perfect reperfusion after a single attempt. Dr. Geyik also noted the catheter's navigability, comparable to market benchmarks, and that 100% of patients achieved TICI 2b or higher within three passes.
Pivotal Study Design
The RapidPulse Pivotal Study is set to enroll approximately 170 patients presenting with recent onset of symptoms indicative of LVO in AIS. The primary endpoint is to demonstrate the safety and effectiveness of the RapidPulse system in achieving rapid and complete clot removal, which is critical for reducing mortality and morbidity associated with stroke.
Addressing Unmet Needs in Stroke Treatment
Each year, an estimated 700,000 strokes occur in the U.S. alone, often resulting from a clot obstructing blood flow to the brain. While existing FDA-cleared devices, such as static aspiration systems and stent retrievers, are used for stroke treatment, studies suggest that these technologies achieve complete or near-complete reperfusion on the first attempt in only about 40% of patients. RapidPulse aims to improve these outcomes with its cyclic aspiration technology.
Technology and Mechanism
The RapidPulse system includes a proprietary console that delivers precise, pulsed aspiration, along with highly trackable catheters and a smart tubing set. This system is designed to optimize the clot removal process by tuning the cyclic algorithm to each catheter size. Sean McBrayer, CEO of RapidPulse, emphasized the importance of the algorithm's precision in achieving high success rates, stating that it allows stroke teams to quickly and effectively restore full reperfusion on the first pass.
A previous study showed that physicians using the RapidPulse system achieved a 21-point improvement in first-pass clot removal rates compared to those using static aspiration alone.
Regulatory Pathway
Following the completion of the RapidPulse Pivotal Study, the data will be submitted to the FDA for 510(k) clearance, which would allow RapidPulse to market the device. Further details on the study endpoints and participating hospital systems are available at www.clinicaltrials.gov.
