Subject: FDA
MicroVention Announces FDA Clearance For Thrombectomy Device
ALISO VIEJO, Calif., June 12, 2018 /PRNewswire/ -- 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."
For more information regarding the SOFIA® Catheter with aspiration indication please visit microvention.com.
About MicroVention, Inc.
Founded in 1997, MicroVention® develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo® Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention® into their family of Companies. Terumo's acquisition of MicroVention® allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases.
Headquartered in Aliso Viejo, California, MicroVention® products are today sold in more than 75 nations through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are located within Aliso Viejo, California, San José, Costa Rica and Saint-Germain-en-Laye, France.
About Terumo® Corporation
Founded in 1921, Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with $5 billion in sales and operations in more than 160 nations. Terumo® develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine. It also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use.
Terumo® contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo® Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
Media Contact:
Cathy Demyanovich
Sr. Director, Corporate Communications
MicroVention. Inc. 800-990-8361
+1-714-247-8000
SOURCE MicroVention, Inc.
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