Engineering company to test thrombectomy device in clinical trial
Amnis Therapeutics, a biomedical engineering company in Israel, has received approval from the Karolinska Institute, a medical university in Stockholm, Sweden, to use its neuro-thrombectomy device on patients for the first time in a clinical trial.
The device, branded the Golden Retriever, extracts blood clots and restores blood flow in the brain, according to a statement from Amnis.
Tommy Andersson, a neurosurgeon and vascular interventionalist, will lead the trial. The study will include 60 patients who suffer from acute ischemic stroke and have a large intracerebral vessel occlusion, a condition that can lead to paralysis or blindness.
"We are happy to start the clinical phase of testing the Golden Retriever, which is the last phase, prior to receiving a CE Mark,” said Aviv Lotan, CEO at Amnis Therapeutics, in a statement. “We believe that the Golden Retriever's attributes suggest significant advantages over existing products for neuro thrombectomy.”
Because the Golden Retriever is small and flexible, it gives physicians easy access and allows them to quickly extract clots of various sizes and consistencies.
Other testing centers will be organized in Barcelona, Spain, and other parts of Israel. Trial investigators have yet to recruit patients, but expect the study to be completed in the first quarter of 2018.