Reverse Medical Corporation Receives US FDA 510k Clearance for the ReCruitTM Microcatheter for Use Including Neuro Interventional Procedures
8/14/2009 8:15:33 AM
IRVINE, Calif.--(BUSINESS WIRE)--Reverse Medical Corporation announced today that it has received US FDA 510k clearance for its ReCruit™ Microcatheter, intended to retrieve intravascular foreign objects during interventional radiology procedures including from the Neurovasculature. This approval allows the Company 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.”
Reverse Medical Corporation is a privately-held medical device company located in Irvine, California. The Company is focused on developing innovative interventional neurovascular devices, including devices for the improvement of acute stroke patient outcomes, and for preventing acute stroke during carotid artery stenting procedures. The Company is working to expand their technology platform to include innovative and state-of-the art treatments for a broad spectrum of neurovascular disorders and carotid artery disease.