Ceretrieve has announced the successful results of the company’s multicentre, single-arm study, showcasing the capabilities of its “state-of-the-art” aspiration catheter in stroke treatment.
The study—conducted across two centres—included 20 patients suffering from acute ischaemic stroke due to intracranial large vessel occlusion (LVO) who were eligible for thrombectomy within 24 hours of symptom onset. The aim of the study was to assess the safety and initial performance of the Ceretrieve device.
“The ‘first-pass effect’ has been shown to improve patient outcomes,” said Shady Jahshan (Galilee Medical Center, Nahariya, Israel), who performed the first neurothrombectomy procedure with the Ceretrieve device. “Our experience in FIH [first-in-human] trials demonstrated that the Ceretrieve device quickly enables complete clot ingestion in first pass—even for the most challenging clots and anatomies. This has the potential to dramatically improve patient clinical outcomes.”
Ceretrieve says that, as shown in the present FIH study, its aspiration catheter not only excelled in performance but also ensured the highest safety standards by reducing the risk of releasing clot fragments further into the brain. In the study, an 80% rate of complete/near-complete perfusion was achieved.
The study included two generations of the device, and the results with the improved, second-generation device are “highly impressive”: a 100% rate of complete/near-complete perfusion was achieved in all treated patients, in addition to an 83% rate of first-pass complete perfusion (modified thrombolysis in cerebral infarction [mTICI] 3) that far exceeds the 30–40% rate of current gold-standard devices.
“The term ‘everything comes with a price’ is not valid for the Ceretrieve device,” said Serdar Geyik (Florya Medical Park, Istanbul, Turkey). “Ceretrieve’s device aspirates the clot with a giant bore tip—double the largest catheters in the market—for maximal vacuum effect without paying the price in trackability. In addition, it provides local flow restriction in the middle cerebral artery, reducing distal emboli. It is the only device that includes all the features for successful thrombectomy and first-pass effect in one single device.”
In a press release, Ceretrieve states that its mission is to transform stroke care, save lives, minimise disability, and significantly improve post-stroke quality of life. Ceretrieve’s aspiration catheter is at the forefront of this mission, delivering aspiration capabilities that are far superior when compared to existing devices, allowing clot removal in a single pass while fully restoring blood flow, according to the company. Designed for seamless integration within a conventional 6Fr delivery catheter, Ceretrieve also claims that its device offers exceptional trackability and manoeuvrability, ensuring efficient access to the clot location.
“The promising results of our clinical studies are the culmination of years of hard work and R&D [research and development],” said Ceretrieve chief executive officer Maysa Mustafa. “Our mission to redefine stroke treatment drives everything we do, and these results signify a major leap forward in saving and dramatically improving lives following an ischaemic stroke.”
“With Ceretrieve’s advanced technology, we are seeing significant improvements in patient recovery rates,” added Ceretrieve chair Amir Belson. “This innovation is setting a new standard in stroke care, offering patients better outcomes and real hope for recovery.”
