FDA grants 510(k) clearance to Carticept Medical's Navigator Delivery System

Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that it has received 510(k) clearance from the Food and Drug Administration to market its Navigator™ Delivery System (Navigator DS) in the United States. The Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.

“The Navigator DS has the potential to change the standard of care for injection procedures”

Arthritis is the leading cause of disability in the United States with more than 46 million Americans having doctor-diagnosed arthritis. Local injections of corticosteroids and anesthetic agents are heavily relied on as early, effective interventions for pain relief. The current standard of practice depends on the expertise of the clinician and the accuracy with which the medications are injected into the affected joint space. According to a recent study published in The American Journal of Sports Medicine, injection accuracy rates are significantly higher when imaging is used in conjunction with injection of the knee and shoulder.

"Minimally invasive and cost-effective injections can delay and in some cases eliminate the need for surgical intervention," 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. "Recent studies have demonstrated greater accuracy with improved function and decreased pain in patients receiving ultrasound-guided injections. The Navigator DS automatically prepares the medication dose, guides accurate needle positioning prior to drug delivery, and simplifies record-keeping—allowing me to spend more quality time with each patient."

The Navigator DS is a comprehensive drug delivery system for convenient operation by a single clinician. The Navigator DS prepares and delivers physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials, eliminating needle exposures to healthcare workers and minimizing the potential for contamination of the medication. Additionally, the automated system helps to ensure accurate dose preparation and saves significant labor for a busy physician practice. The ultrasound screen provides the physician with real-time visualization of the needle position, fluid delivery process and prescription volume. After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic record management system.

"The Navigator DS has the potential to change the standard of care for injection procedures," said Charles E. Garten II, M.D., director of Primary Care Sports Medicine at Myers Sports Medicine and Orthopaedic Center in Atlanta. "The Navigator DS simplifies the set-up of multi-drug injections, while the integration with ultrasound imaging provides me with real-time feedback regarding the accuracy of the needle placement. Automating the manual steps of procedures will ultimately help improve patient care, increase efficiency and maximize patient throughput in the sports medicine clinic."

"The FDA clearance of the Navigator DS provides physicians with a complete, computer-controlled intelligent injection system," said Timothy J. Patrick, president and chief executive officer of Carticept. "In addition to its use in sports medicine and orthopaedics, we believe the technology has future applications in anesthesiology, radiology and other specialties that require accurate dose delivery."