Catheter Robotics, Inc. is pleased to announce 510(k) clearance of Amigo™ by the Food and Drug Administration (FDA). Catheter Robotics will enter the US market with right-sided diagnostic approval with the Blazer® DX 20 catheter (Boston Scientific).
Amigo™ is a remote catheter system that allows physicians to operate a catheter some distance from the radiation field, up to 100 feet. It is designed to be compatible with third party catheters and to easily integrate into a hospital's existing electrophysiology lab. When placed on the Amigo system, the catheter is navigated by a remote controller that mimics catheter handles, reducing the time needed for physicians to learn and feel comfortable using a robotic catheter system.
David Jenkins, President and CEO believes that the approval of Amigo is not only beneficial for Catheter Robotics, but also for the advancement of robotics in the electrophysiology field. "We have a product that will benefit physicians and hospitals and we are excited to have it available to the marketplace. Amigo meets the performance expectations of physicians while meeting the cost expectations of hospitals, and creates a solution to the unmet needs of current robotic systems. Catheter Robotics continues to be dedicated to meeting the needs of patients, physicians and hospitals within the electrophysiology lab."
Amigo was evaluated at 13 centers worldwide which enrolled more than 200 patients. Jennifer Englund, Vice President of Clinical and Regulatory Affairs feels very positive about the results of the clinical trial. "The clinical trial was a great success and resulted in data that exceeded our safety and efficacy objectives. The trial data demonstrated effective catheter navigation with Amigo (sufficient tissue contact, ability to navigate the catheter to multiple pre-determined points in the right heart, and ease of use) and a strong safety profile (no major complications related to Amigo). We are truly excited to have 510(k) clearance of Amigo by the FDA, which allows us to market the device in the US."