Expanded Indication for the SOFIA Catheter Receives FDA OK
The catheter is now indicated for use with an aspiration technique for blood clot removal in patients with acute ischemic stroke.
Today the US Food and Drug Administration issued clearance of a new indication for the SOFIA Catheter (Soft TOrqueable catheter For Intracranial Access). The new indication includes contact aspiration technique for revascularization among patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.
The catheter is now indicated for use during a thrombectomy procedure to help remove blood clots blocking a vessel in the brain and restore the blood flow bringing oxygen and nutrients to that area of the brain.
"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," said Markus Möhlenbruch, MD, Section Chief of Interventional Neuroradiology, Heidelberg University Hospital, Germany.
In patients with ischemic stroke, the SOFIA Catheter is designed to provide excellent trackability and a large inside lumen, allowing for a quick and effective restoration of blood flow to the parts of the brain impacted by the blood clot.
"We are very excited to have a product that can effectively provide a viable option for the treatment of the devastating disease of stroke," said Richard E. Cappetta, President and CEO, MicroVention, Inc.
The SOFIA Catheter has already been approved for the aspiration indication in Europe (CE marked) since 2015 and has been used in other countries.
"This new indication expands the tools available for physicians to be able to help their patients who are presented with an ischemic stroke," said Cappetta.
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