FDA Clears Blockade Medical Embolization Coil System

Blockade Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Barricade coil system, an embolization coil line designed to endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The system is a bare platinum coil line available in framing, filling and finishing shapes. The Barricade Coil System received CE mark in July last year.

“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,” said Michael Chen, M.D., of Rush University Medical Center in Chicago, Ill., the first center in the United States to use the Barricade Coil System.

“Our initial clinical experience with the Barricade coil system has been positive,” said Alex Spiotta, M.D. from the Medical University of South Carolina in Charleston. “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.”

“We are very pleased to have received FDA clearance for the Barricade coil system,” said Gibb Clarke, CEO of Blockade Medical. “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.”

Blockade Medical makes devices for treatment of hemorrhagic stroke and related diseases of the neurovascular system. The company manufactures the Barricade Coil System in the United States and is based in Irvine, Calif.