Oct 8 2009
Reverse Medical Corporation announced today they have initiated human use of their ReStore™ Microcatheter for reestablishing blood flow in the Neurovasculature. The device was successfully used in an acute ischemic stroke patient in Germany.
Commenting on this significant clinical milestone, Reverse Medical’s President and Chief Executive Officer Jeffrey Valko said, “Human use is always a major milestone to achieve, and the success of the ReStore Microcatheter has now validated our pre-clinical experiences. Demonstrating safety and device performance in the clinical setting will continue to build a strong foundation for accelerating enrollment into our 2010 clinical trial supporting a FDA 510k clearance. Reverse Medical will continue to pursue a broadening platform of state-of-the-art endovascular devices for the treatment of neurovascular disorders.”
Reverse Medical has received enthusiastic support from numerous European centers who have been trained to date on the new technology. Comments from the Company’s lead physician related to the human use experience include, “It is a very clever design and intuitive for use. The options for quickly reestablishing blood flow past the clot, infusing into the clot, or performing thrombectomy, all from one device is very appealing and a clear advancement over other devices for treating acute ischemic stroke patients.”
Source:
Reverse Medical Corporation