FDA Clears Carticept Medical for Musculoskeletal Injection Device
Carticept Medical Inc., a drug delivery systems company based in Alpharetta, Ga., has been granted 510(k) clearance from the U.S. Food and Drug Administration for its enhanced Navigator delivery system (DS). According to the company, it is 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 often are 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 is designed to automatically prepare these injections directly from the manufacturers’ drug vials, which reportedly would save 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 printout. 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 orthopedic surgery at Yale University School of Medicine in 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 pursuing development of our technology’s use in the anesthetic nerve block application and look forward to bringing that product to the market in the near future.”
Carticept Medical focuses on technology to improve the safety, efficiency and accuracy of many common injection procedures.