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 products.
“Three Rivers Medical’s major strategic value to the growing interventional neuro market is in our ability to develop innovative interventional products rapidly and in a cost efficient manner without compromising quality. The process is complimented by our broad network of international distributors and physicians who provide critical design input to our product development process,” R&D VP Dean Carson added.
“I evaluated the Rio coil in two complex multi-lobe aneurysms and the Rio coil allowed me to effectively pack these difficult aneurysms. The ultrasoft coils were very compliant giving me exceptional microcatheter stability and the visual detachment system gave me instant confirmation of successful coil detachment, highly valuable information in my opinion,” Dr. Wojciech Poncyljusz of Hospital Szczecin Poland said in a press release.