Carticept Medical get FDA Approval for Navigator Delivery System

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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.

“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.”

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.

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