Carticept® Medical Receives 510(k) Clearance for Second Generation Navigator® Delivery System
Clearance is Carticept's Fifth to be Granted through the New Draft FDA Regulatory Guidance for 510(k) Infusion Pump Submissions
ALPHARETTA, Ga. --
Carticept Medical, Inc., a developer of innovative drug delivery systems, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its enhanced Navigator® Delivery System (DS), the first and only FDA-cleared, computer-controlled injection system intended to increase the efficiency, comfort, safety and accuracy of musculoskeletal injections.
Arthritis is the leading cause of disability in the United States with an estimated 50 million adults having doctor-diagnosed arthritis. Local injections of corticosteroids and anesthetics are often relied on as an early, effective intervention for pain relief, with an estimated 30 million orthopedic injections given in the United States alone each year.
Standard intra-articular injections often consist of a corticosteroid and two anesthetics, requiring manual access into several drug vials to prepare a dose for each patient. The Navigator DS automatically prepares these injections directly from the manufacturers' drug vials, saving significant labor for a busy physician practice while eliminating needle exposure. Navigator DS automates accurate medical recordkeeping by recording the treatment data for transfer to an electronic record management system or direct print-out. The Navigator DS also offers optional integration with ultrasound imaging to improve the accuracy of intra-articular injections.
The enhanced Navigator DS incorporates multiple new software features intended to improve further office and workflow efficiency.
"The current standard for preparing doses of intra-articular injections is inefficient and consumes significant resources in an active office practice," said John S. Reach, Jr., M.Sc., M.D., director of the Yale Foot and Ankle Section and assistant professor in the department of Orthopaedic Surgery, Yale University School of Medicine, New Haven, Conn. "I have been using this latest version of the Navigator DS since its clearance last month, and have been impressed with the significant efficiencies it brings to my office, freeing up more of my time to spend on patient care."
"Improving patient safety and office workflow are two significant issues facing healthcare today," said Timothy J. Patrick, president and chief executive officer of Carticept. "We believe that the Navigator DS' computer-controlled preparation, delivery and recordkeeping of these medications addresses these issues with technology that will change the current standard of care. We are aggressively pursuing development of our technology's use in the rapidly growing anesthetic nerve block application and look forward to bringing that product to the market in the near future."
About Carticept Medical, Inc.
Based in Alpharetta, Ga., Carticept Medical, Inc. is a privately held medical device company that develops and markets innovative platform technologies to improve the safety, efficiency and accuracy of many common injection procedures. The company's Navigator Delivery System for orthopedic injections is the first and only FDA-cleared computer controlled medication delivery system for intra-articular injections. Carticept's primary investors include Domain Associates, New Enterprise Associates and SonoSite, Inc. For more information on the company or the Navigator DS, visit www.carticept.com.