Israeli vascular-focused bio-engineering company Amnis Therapeutics said today it won Swedish approval for a 1st-in-human clinical trial of its Golden Retriever neuro thrombectomy device.
The trial will be led by neurosurgeon Dr. Tommy Andersson, and is slated to enroll 60 acute ischemic stroke patients with large intracerebral vessel occlusion, the company said.
“We are happy to start the clinical phase of testing the Golden Retriever, which is the last phase, prior to receiving a CE Mark. We believe that the Golden Retriever’s attributes, suggest significant advantages over existing products for neuro throbemctomy. Prof. Andersson is one of Europe’s best neuro interventionalists, who found the Golden Retriever interesting enough to spearhead our European clinical trial,” CEO Aviv Lotan said in a press release.
Amnis said it will being recruiting patients “shortly” with a hopes for conclusion date during the 1st quarter of 2018. New clinical centers are slated to be added in Barcelona, Spain and Israel, the company said.
In the trial, physicians will use the Golden Retriever device to extract blood clots from patients to restore normal blood flow. The trial will act as a basis for the company’s CE Mark application as it seeks European Union approval for the device.