Medical Device Network

Ceretrieve touts positive data from aspiration catheter study

The first in human study demonstrated an 80% complete / near-complete perfusion rate in 20 acute ischaemic stroke patients.

Ceretrieve has announced positive study results demonstrating that its aspiration catheter demonstrated clot removal, completely restoring blood flow in a single pass.

The Ceretrieve aspiration catheter is a medical device used to remove blood clots from blood vessels in the body. It works by using a vacuum or suction effect to draw out unwanted material, aiding in the treatment of stroke, or deep vein thrombosis.

The first-in-human study demonstrated that an 80% complete / near-complete perfusion rate was achieved. The study included two generations of the device, with the improved Gen 2 device showing 100% complete / near-complete perfusion in all treated patients, and 83% first-pass complete perfusion (FPE mTICI 3). This exceeds the 30%-40% rate of current gold-standard devices, according to the 28 May announcement.

The study enrolled 20 patients who suffered from acute ischemic stroke (AIS) due to intracranial large vessel occlusion (LVO) and were eligible for thrombectomy – a medical procedure used to remove a blood clot from a blood vessel – within 24 hours of symptoms starting. According to GlobalData’s epidemiologists, there will be 96,246,493 cases of AIS by 2027 globally.

The first neurothrombectomy procedure performed with the device was by Shady Jashan, the director of Interventional Neuroradiology at Israel’s Galilee Medical Center.

Jashan said: “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.”

According to GlobalData’s medical device pipeline database, 20 aspiration catheter devices are in various stages of development globally. Ceretrieve is one of the leading players in the space, alongside HeMo Bioengineering, RapidPulse and Route 92 Medica.

Last month, medical device giant Johnson & Johnson (J&J) announced the launch of its Cereglide aspiration catheter in Europe, adding to its stroke solutions portfolio that includes a revascularisation device and clot extractor.

In addition, Expanse ICE’s aspiration thrombectomy system ICE Aspiration System received 510(k) clearance from the US Food and Drug Administration (FDA) in April 2024. It features a dual-lumen design to create the patented Surge Aspiration technology, a novel cyclic aspiration type at the distal end of the catheter.