Blockade Medical Announces 510(k) Clearance of the Barricade Coil System
Published: Apr 29, 2013
IRVINE, Calif.--(BUSINESS WIRE)-- Blockade Medical L.L.C., a privately held company focused on the development of catheter based therapeutic devices for the treatment of cerebral aneurysms, announced today that the Barricade Coil SystemTM has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) and that the first series of clinical cases treated with the Barricade Coil System in the United States has been successfully completed.
Rush University Medical Center in Chicago, Illinois was the first center in the United States to use the Barricade Coil System. Michael Chen, M.D. commented, “The softness profile of the finishing coils proved very helpful in my case. They provided the ability to effectively pack the aneurysm while providing a stable microcatheter.”
“Our initial clinical experience with the Barricade Coil System has been positive. The Barricade Coil System is a full coil line which can be successfully used to treat a variety of morphologies. We have been particularly impressed with the softness and deliverability profile of the finishing coil which is competitive to any other coil currently on the market,” said Dr. Alex Spiotta, M.D. from the Medical University of South Carolina in Charleston, South Carolina.
“We are very pleased to have received FDA clearance for the Barricade Coil system. This is a significant achievement as we continue the successful commercialization of the Barricade Coil System. The initial clinical feedback in the United States reinforces the positive feedback from our international experience and we look forward to impacting patient lives in a positive way,” said Gibb Clarke, Blockade Medical’s CEO.
About the Barricade Coil System:
The Barricade Coil System is an embolization coil line which is designed to endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The Barricade Coil System is a comprehensive bare platinum coil line available in framing, filling and finishing shapes. The Barricade Coil System received CE Mark in July, 2012.
About Blockade Medical:
Blockade Medical is a privately held medical device company focused on expanding the endovascular management of hemorrhagic stroke and related disease of the neurovascular system. The company manufactures the Barricade Coil System in The United States and is based in Irvine, California.
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