Last summer we announced the CE marking of Blockade Medical’s cerebral aneurysm coil system, here. Now the company has seen its Barricade™ Coil System receive FDA 510(k) Clearance.
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 first series of clinical cases treated with the Barricade Coil System in the United States, was performed at Rush University Medical Center in Chicago, Illinois .
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.
Source: Blockade Medical, LLC., Business Wire