Three Rivers Medical's Rio Embolization Coil System Receives CE Mark Approval
February 20, 2018-Three Rivers Medical, Inc. announced that it has received CE Mark approval for the Rio embolization coil system, which is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulas. The device is also indicated for arterial and venous embolization in the peripheral vasculature. The Rio embolization coil system is not approved for sale in the United States, advised the company.
Additionally, the company announced that after CE Mark approval, Rio coils were used in 10 challenging and complex cases. The coils' performance was complimented by the system's mechanical detachment system, which has visual detachment confirmation that provides immediate and visual fluoroscopic confirmation of successful coil detachment.
According to the company, the Rio embolization coil system is approved in 10 and 18 standard, soft, and ultrasoft coil configurations, ranging in lengths from 22 mm down to 1 mm. The company plans to start commercialization through prominent international distributors in territories that recognize the CE Mark.
The CE Mark approval was granted in October 2017, allowing the company to market the Rio embolization coil system in the European Union and other countries that recognize CE Mark for commercial distribution purposes. Three Rivers Medical is actively pursuing additional regulatory approvals in all key global markets.