MicroVention Announces FDA Clearance For Thrombectomy Device

Wednesday, June 13, 2018

MicroVention, Inc. a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA clearance of a new clinical indication for the SOFIA® Catheter (Soft TOrqueable catheter For Intracranial Access) to include contact aspiration technique for successful revascularization among patients with acute ischemic stroke, secondary to intracranial large vessel occlusive disease.

When considered separately from other cardiovascular diseases, stroke ranks No. 5 among all causes of death in the US, with nearly 133,000 people's lives lost every year. Someone in the US has a stroke about once every 40 seconds and stroke accounts for 1 of every 19 deaths.  (Source: American Stroke Association 2018)

An ischemic stroke is a type of stroke caused by a blockage of blood flow within a blood vessel in the brain. The brain cells downstream of the blockage are deprived of oxygen and nutrients and will quickly die if left untreated. A thrombectomy procedure using an aspiration catheter can help to remove blood clots from a blocked vessel of the brain and restore blood flow to those vessels.

"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 PD Dr. Markus Möhlenbruch, Section Chief of Interventional Neuroradiology, Heidelberg University Hospital, Germany.

The SOFIA® Catheter has been approved in Europe (CE marked) for aspiration indication since 2015 and has been safely used in other parts of the world to treat acute ischemic stroke. The unique design of the SOFIA® Catheter allows for great trackability and a large inside lumen, to provide a fast and effective way to restore blood flow in stroke patients.

"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. "This new indication expands the tools available for physicians to be able to help their patients who are presented with an ischemic stroke."

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