Ceretrieve Aspiration Catheter Evaluated in FIH Procedures to Treat Ischemic Stroke

May 28, 2024—Ceretrieve Ltd., a neurointerventional device company headquartered in Yokneam, Israel, announced the results of the company’s multicenter, single-arm, first-in-human (FIH) study assessing the safety and initial performance of the Ceretrieve aspiration catheter.

The study was conducted at two centers. It included 20 patients who experienced acute ischemic stroke (AIS) caused by intracranial large vessel occlusion and who were eligible for thrombectomy within 24 hours of symptom onset.

According to the company, the Ceretrieve aspiration catheter achieved 80% complete/near-complete perfusion in the FIH study. In addition to performance, it demonstrated safety by reducing the risk of releasing clot fragments further into the brain.

The Ceretrieve aspiration catheter is designed for integration within a conventional 6-F delivery catheter. It is intended to allow clot removal in a single pass, while fully restoring blood flow.

The company noted that the study included two generations of the device.

The results with the improved second-generation device included 100% complete/near-complete perfusion in all treated patients and 83% first-pass complete perfusion—first-pass effect (FPE), defined as achieving modified treatment in cerebral infarction (mTICI) grade 3 reperfusion (FPE mTICI 3)—compared with the 30% to 40% rate of current gold-standard devices.

Shady Jashan, MD, of Galilee Medical Center in Nahariya, Israel, performed the first neurothrombectomy procedure with the Ceretrieve device.

“The FPE has been shown to improve patient outcomes,” commented Dr. Jashan in the Ceretrieve’s press release. “Our experience in FIH trials demonstrated that the Ceretrieve device quickly enables complete clot ingestion in the first pass even for the most challenging clots and anatomies. This has the potential to dramatically improve patient clinical outcomes.”

Professor Serder Geyik, MD, of Florya Medical Park Hospital in Istanbul, Turkey, added, “The term ‘everything comes with a price’ is not valid for the Ceretrieve device. 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 FPE in a single device.”