Animal trial results of A Novel Mechanical Thrombectomy Device
Ronit Agid¹ (presenting), Adnan Siddiqui², Tommy Andersson³
Toronto Western Hospital, Toronto, Ontario, Canada¹, Toshiba Stroke research center, Buffalo, NY, USA², Karolinska Institute, Stockholm, Sweden³
The Golden retriever is a 0.014’’ wire tube equipped with a soft tip. An external lever unfolds five crown like elements, each one composed of 12 feather-like micro-strands. These are extended and embedded into the clot by rotation.
With no radial force on the vessel wall, the Golden Retriever navigates quickly and easily, similar to a wire, with minimal friction through the microcatheter. The Golden’s microcatheter-independent deployment makes the procedure almost a-traumtic. Golden’s one-size-fits-all mechanism with enhanced gripping ability captures the clot from within and is designed to enable excellent clot engagement regardless of morphology and clot size.
Safety Study: 20 retrievers were used in 7 arteries. There was no angiographic evidence of dissection, contrast extravasation or thrombus formation, both acutely and chronically, but varying degrees of vasospasm were noted in most of the manipulated swine vessels. Following a histopathological examination (acute and chronic (90 days)), device was proven to be equivalent and even superior to compared device.
Performance Study: 20 retrievers were used in 15 arteries to extract 15 clots. There was no angiographic evidence of dissection, contrast extravasation or thrombus formation, but varying degrees of vasospasm were noted in most of the manipulated swine vessels. 14 out of 15 procedures had successful recanalization result. TICI score was 2b-3 in these 14 successful cases. In 12 cases clots were retrieved successfully with one pass, in 1 case 2 passes and in another case 3 passes were required. In one procedure clot retrieval after 3 attempts could not be achieved.
Additional animal study: Seven additional procedures were conducted with and without aspiration, where all clots were retrieved in one pass and no vasospasm was observed.
These studies were performed in Israel, USA and Sweden.
Summary: In animal studies the Golden Retriever was found to be an atraumatic and safe device with high success rate retrieving clots (93.8%). First in human trial will start soon.