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October 9, 2011

Carticept’s Navigator DS gets FDA clearance

The US Food and Drug Administration (FDA) has granted 510(k) approval for Carticept Medicals' Navigator Delivery System (Navigator DS) to treat cartilage injuries and osteoarthritis.

The US Food and Drug Administration (FDA) has granted 510(k) approval for Carticept Medicals’ Navigator Delivery System (Navigator DS) to treat cartilage injuries and osteoarthritis.

The Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance that is designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.

The ultrasound screen incorporated in the Navigator DS provides physicians with real-time visualisation of needle position, the fluid delivery process and prescription volume.

The system prepares and delivers physician-prescribed injections from standard multi-dose anaesthetic and steroid drug vials.

The Navigator DS automatically records the treatment data after the injection is delivered and creates a record for transfer to an electronic record management system.

Carticept president and CEO Timothy Patrick said that in addition to its use in sports medicine and orthopaedics, the company believes that the technology has future applications in anesthesiology, radiology and other specialties that require accurate dose delivery.

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