FDA Clears Contact Aspiration Indication for MicroVention's Sofia Catheter
June 12, 2018—MicroVention, Inc., a United States–based subsidiary of Terumo focused on neurovascular therapies, announced that the US Food and Drug Administration has granted clearance of a clinical indication for the company's Sofia catheter to include the contact aspiration technique for revascularization in patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.
The company stated that the device's design allows for trackability and a large inside lumen to provide a fast and effective way to restore blood flow in stroke patients. The Sofia catheter received European CE Mark approval for the aspiration indication in 2015.
Markus Möhlenbruch, MD, commented in MicroVention's announcement, "In my clinical experience, the unequaled tracking performance and the increased reperfusion capability of the Sofia catheter make a major difference when treating patients suffering from an ischemic stroke. The Sofia catheter makes my practice less challenging, reducing navigation time and providing effective clot extraction." Dr. Möhlenbruch is Section Chief of Interventional Neuroradiology at Heidelberg University Hospital in Heidelberg, Germany.