A study recently published online in the journal Interventional Neuroradiology has provided multicentre trial results that demonstrate the promise of using precise cyclic aspiration in the treatment of acute ischaemic stroke, as per a press release put out today by US startup RapidPulse.
The RapidPulse feasibility study saw researchers compare their ability to restore blood flow in large vessel occlusion (LVO) ischaemic stroke patients using standard (static) aspiration versus with the company’s new technology, which precisely cycles aspiration to increase the removal rate of blood clots in the brain. RapidPulse—a spinout of innovative medical device incubator Syntheon 2.0—sponsored the study, which enrolled patients in Turkey, Brazil, Spain, Latvia, and Denmark.
In the study, 40 patients were enrolled in the RapidPulse arm and treated using a 0.071-inch catheter, with five of those patients being excluded from the per-protocol analysis because they did not meet all the eligibility criteria. Meanwhile, a control arm comprised of 40 patients who met all the inclusion and exclusion criteria, and had been treated within 12 months of 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 inches—to treat the control arm patients via standard aspiration pumps.
The purpose of the study was to compare the percentage of patients who achieved almost complete (2c) or complete (3) reperfusion at the first aspiration attempt using the modified Thrombolysis in cerebral infarction (mTICI) scale.
The study ultimately found that the rate of mTICI scores ≥2c after the first pass was 60% among patients treated with RapidPulse who met all eligibility criteria versus 38.5% in the corresponding control arm. This greater than 21-point improvement in first-pass clot removal rates led the authors to conclude that the RapidPulse system is “highly effective and safe for the removal of large vessel occlusions”.
“This is an exciting improvement for the treatment of ischaemic stroke due to large vessel occlusion,” said study author Serdar Geyik (Istanbul Aydin University, Istanbul, Turkey). “Higher recanalisation 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 recanalisation 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,” added RapidPulse chief executive officer Sean McBrayer. “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. 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.”
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, the company claims.
Future studies of a new version of the RapidPulse technology are expected to begin enrolling patients in 2024, the recent release adds, going on to detail that the device is not currently commercially available for sale in the USA or other markets.
