The FDA has given Irvine-based Reverse Medical Corp. the go-ahead to market its line of advanced-access intracranial catheters for use during interventional neurovascular procedures, including the treatment of aneurysms.
The ReFlex Catheter product lineup was developed to provide specialists with devices that can navigate into intricate neurovascular anatomies. The technology is expected to help industry professionals treat a larger range of patients.
"The clearance of ReFlex demonstrates that Reverse Medical truly understands the needs of the neurointerventionalist," said Reverse Medical President and CEO Jeffrey Valko. "We believe the ReFlex Catheter line of devices will allow physicians to expand their therapeutic options for treating previously underserved patient populations."
Reverse Medical is a privately held company developing devices for the treatment and management of acute stroke and neurovascular disease. The company's ReFlex A+ Catheter earlier this year was approved for commercialization in the European Union.
"The bar has been raised for achieving FDA 510k clearance, and the ReFlex clearance for commercialization represents a significant step forward for the growth of Reverse Medical," said Valko. "With our recently announced ReFlex CE Mark, this 510k now allows us to initiate worldwide commercialization."
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