RapidPulse announced today that the US Food and Drug Administration (FDA) has agreed that the company can begin enrolment in an investigational device exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow US and European patient enrolment in 2025 as part of a study designed to demonstrate that RapidPulse’s patented method of precisely pulsed aspiration is safe and effective in the treatment of acute ischaemic stroke. A press release notes that the company’s technology is a spinout of Syntheon 2.0—an innovative medical device incubator with a long track record of successful exits.
The RapidPulse system that will be used in the IDE study was recently trialled in 19 large vessel occlusion (LVO) patients enrolled at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asuncion in San Lorenzo, Paraguay and Istanbul Aydin Universitesi in Istanbul, Türkiye.
“Using the new RapidPulse system, we achieved a 68% first-pass effect of TICI [thrombolysis in cerebral infarction] 2c or better. This means almost seven out of 10 acute ischaemic stroke 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,” said leading investigator Serdar Geyik (Istanbul Aydin Universitesi, Istanbul, Türkiye).
The RapidPulse pivotal study is targeted to enrol approximately 170 patients with recent onset of symptoms indicative of LVO in acute ischaemic stroke. Upon completion of the study, data will be submitted to the US FDA for consideration of RapidPulse receiving 510(k) clearance to market the device.
The company’s release details that, while previously FDA-cleared devices for the treatment of stroke have used either static aspiration, a stent retriever, or a combination of the two, many published studies have shown these currently available technologies only achieve complete or near complete reperfusion on the first attempt in approximately four out of 10 patients. RapidPulse claims to be 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, as well as highly trackable catheters, and a smart tubing set that ensures the company’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, chief executive officer (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 static aspiration alone, the company also claims in today’s release.
