Reverse Medical Corporation announced that it has received US FDA 510k clearance for ReCruit Microcatheter. The microcatheter is intended to retrieve intravascular foreign objects during interventional radiology procedures including from the Neurovasculature. The approval allows the Reverse Medical Corporation to market the ReCruit Microcatheter in the United States for commercial distribution purposes.
Commenting on this significant regulatory milestone, Reverse Medical’s Chief Executive Officer Jeffrey Valko said, “US FDA clearance of the Reverse Medical ReCruit Microcatheter represents an important strategic step for the Company, as we work to expand our product designs and indications for use toward Neuro Interventional market leadership. With this regulatory clearance for US marketing, initial clinical use will be closely managed to collect data demonstrating superior clinical value compared to competitive products prior to broad commercialization efforts. The Company expects to commence commercialization in early 2010.”
Reverse Medical scientific and clinical advisor Dr. Satoshi Tateshima, MD, D.M.Sc., UCLA Stroke Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA stated, “I believe the Reverse Medical ReCruit Microcatheter is a very innovative device that will serve as a platform technology for even more advanced interventional neurovascular devices. As a Neuro Interventionalist, the ability for me to control the ReCruit Microcatheter’s distal tip rate of radial deployment is quite unique and represents a significant improvement over other devices I’ve 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.”