FDA Clears Reverse Medical's ReCruit Microcatheter for Neurointerventional Procedures
August 14, 2009—Reverse Medical Corporation (Irvine, CA) announced that it has received US Food & Drug Administration 510(k) clearance for its ReCruit microcatheter, which is intended to retrieve intravascular foreign objects during interventional procedures, including from the neurovasculature. With this regulatory clearance for United States marketing, the company said that it would closely manage initial clinical use of the device to collect data demonstrating its clinical value compared to competitive products before broad commercialization efforts commence in early 2010.
"I believe the ReCruit microcatheter is a very innovative device that will serve as a platform technology for even more advanced interventional neurovascular devices," commented Satoshi Tateshima, MD. "As a neurointerventionist, the ability for me to control the distal tip rate of radial deployment is quite unique and represents a significant improvement over other devices I have used. Furthermore, the device's superior flexibility allows for deep brain navigation through tortuous anatomy, and the infusion capability adds additional options for advanced site-specific use."