Jul 20 2012
Blockade Medical™ announced today that it has received CE Mark (Conformité Européenne) for its Barricade Coil System™. The Barricade Coil System is designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE Mark allows the Company to market the Barricade Coil System in the European Union and other countries that recognize the CE Mark for commercial distribution purposes The Barricade Coil System provides the neurovascular specialist with a complete coil embolization line that can occlude complex neurovascular aneurysms and other vascular abnormalities.
Commenting on this regulatory approval, Blockade Medical's Chief Executive Officer Gibb Clarke said, "The use of platinum microcoils to treat intracranial aneurysms will continue to expand the neurovascular market. Coil embolization is the standard of care and is proven to be safe and effective for both ruptured and unruptured aneurysms. It is because of this safety and efficacy record that coil embolization will remain the standard of care in aneurysm treatment for years to come. The Barricade Coil System is our first product offering, which Blockade plans to complement with additional products in 2013."
Blockade Medical was formed in the Fall of 2011 and quickly formed a technical team to develop and gain approval for its Barricade Coil System. In addition, the Company is developing a pipeline of innovative products to complement its coil embolization line. According to Blockade's President Dave Ferrera, "Blockade's major strategic value to the interventional market is in its ability to develop innovative interventional products rapidly on a cash efficient operating plan, complimented by a broad network of international distributors and physicians that provide critical input to our product development process."
Blockade Medical clinical advisor Dr. Raymond Turner, Endovascular Neurosurgeon, Medical University of South Carolina, Charleston, South Carolina, stated, "From my initial experience, the Barricade Coil System offered competitive performance in terms of deliverability, aneurysm conformability, filling and finishing. The framing coil allows me to frame and fill the aneurysm effectively while delivering coils without sacrificing catheter position. The system also offers long filling and soft finishing coils to enable complete aneurysm embolization."
The Company believes the Barricade Coil System line of embolization coils will allow physicians and hospitals to safely and efficiently provide therapeutic options for treating cerebral aneurysms. The Barricade Coil System is approved in 10 & 18 framing, filling and finishing coil configurations. The Company plans to immediately commence European and Latin American commercialization through prominent international distributors, in territories that recognize the CE Mark.