Three Rivers Medical, Inc. announced it has received CE Mark (Conformité Européenne) for its Rio Embolization Coil System™ and has successfully treated its first ten patients. The Rio Embolization Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The RECS is also indicated for arterial and venous embolization in the peripheral vasculature. The CE Mark, granted in October 2017, allows the Company to market the Rio Embolization Coil System in the European Union and other countries that recognize the CE Mark for commercial distribution purposes. The Rio Embolization Coil System provides the neurovascular specialist with a best in class embolization coil line complimented by a first of its kind and patent protected visual detachment system. The company is actively pursuing additional regulatory approvals in all key global markets.
Commenting on this regulatory approval and first clinical usage, Three Rivers Medical’s Chief Executive Officer, Gibb Clarke said, “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. 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.”
Three Rivers Medical, Inc. was formed in the May 2015 around a core technical team to develop, and gain approval for, its Rio Embolization Coil System. In addition, the Company is developing a pipeline of innovative products to complement its coil embolization line. According to Three Rivers Medical’s Vice President of Research & Development, Dean Carson, “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.”
Speaking about his first successful clinical experience in two challenging intracranial aneurysm cases, Professor Wojciech Poncyljusz, CEO of the Polish Neuroradiology Society and Head of the Department MSWiA Hospital Szczecin Poland, stated, “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.”
The Rio Embolization Coil System product line provides a safe and effective treatment option to physicians and hospitals for the treatment of cerebral aneurysms and other vascular malformations. The Rio Embolization Coil System is approved in 10 & 18 Standard, Soft, and Ultrasoft coil configurations, ranging in lengths from 22mm down to 1mm. The Company plans to commence commercialization through prominent international distributors, in territories that recognize the CE Mark.
