Three Rivers Medical wins CE Mark for Rio aneurysm embolization device

Three Rivers Medical said yesterday that it won CE Mark approval in the European Union back in October for its Rio embolization coil for treating brain aneurysms. Mountain View, Calif.-based Three Rivers said it also treated the first 10 patients with the Rio device, which is also CE Marked for peripheral embolizations. The company said it plans to go to market via distributor in territories that recognize the mark. “The use of embolization coils to treat intracranial aneurysms continues to be the global gold standard for therapeutic neurovascular interventions and is proven to be safe and effective for both ruptured and unruptured aneurysms,”CEO Gibb Clarke said in prepared remarks. “I personally attended and trained our customers for the first 10 cases. Our coils were used in challenging and complex cases and in all circumstances performed exceptionally well. Our coil performance was complimented by our novel mechanical detachment system with a first-of-its-kind visual detachment confirmation, providing our customers with both immediate and visual fluoroscopic confirmation of successful coil detachment. For a small emerging company intent on making an impact on this market, a competitive coil line is a great place to start. As a company we have our eye on developing an expanded product portfolio that is complementary to our Rio embolization coil system.” In addition to the Rio coil, Three Rivers said it’s developing a pipeline of complementary...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Neurological Regulatory/Compliance Three Rivers Medical Source Type: news