FDA Approvals: PediGuard, OmniPod, Regenafil, Optefil, Osteofil

Yael Waknine

February 25, 2005

Feb. 25, 2005 — The U.S. Food and Drug Administration (FDA) has approved a wireless drilling device with tissue-type detection capability to minimize potential pedicular or vertebral breaches during pedicle screw placement; a system for continuous subcutaneous insulin delivery with wireless monitoring for use in the management of type 1 diabetes; and demineralized bone matrix allograft paste products for use in spinal and orthopaedic applications to fill voids in bone.

Drilling Device (PediGuard) Detects Tissue-Type Changes for Improved Accuracy of Pedicle Screw Placement

On Dec. 29, the FDA approved a hand-held, wireless drilling device (PediGuard Nerve Detector System, made by SpineVision) for real-time detection of possible penetration outside the vertebral pedicle during pedicle screw placement in spine surgery. No changes in surgical technique are required for its use.

The device monitors the electrical conductivity of tissue at its tip, providing continuous feedback to the surgeon via visual and audible alerts to indicate whether the tip is in contact with cortical bone, cancellous bone, soft tissue, or blood. The feedback warns surgeons of potential pedicular or vertebral breaches during pedicle screw site preparation, thus reducing the risk of misplacement.

The device is also indicated for use in intraoperative electromyographic (EMG) surveillance to assist in the location and evaluation of spinal nerves during surgery. It is used to administer low voltage electrical energy to tissues and nerves at the operative site during EMG monitoring of muscle groups associated with those nerves.

Insulin Management System (OmniPod IMS) for Type 1 Diabetes

On Jan. 11, the FDA approved an insulin management system (OmniPod IMS, made by Insulet Corp.) for use in patients with type 1 diabetes.

The system consists of a continuous subcutaneous insulin infusion device with an automatic inserter and insulin reservoir (OmniPod) and a wireless, hand-held personal diabetes manager (PDM). The PDM is programmable and features multiple basal rates and bolus options, suggested bolus calculations, safety checks, and alarms. Once programmed, it can be used to check blood glucose levels as well as give bolus doses and adjust basal rates.

Because there is no tubing connecting the PDM to the OmniPod, it can be carried separately when not in active use. Each OmniPod is designed for three-day use, after which it is replaced.

The system is also capable of storing and reviewing insulin delivery, carbohydrate, and blood glucose results, and includes a built-in food reference library.

Allograft Demineralized Bone Matrix Paste (Regenafil, Optefil, Osteofil) Fills Voids in Bone

On Feb. 14, the FDA approved demineralized bone matrix (DBM) allograft paste products (made by Regeneration Technologies, Inc.) for use in spinal and orthopaedic applications to fill voids in bone.

The products consist of allograft DBM and a gelatin carrier. The insolubility of the material in fluids at body temperature allows it to remain in place during irrigation.

The DBM products are packaged and marketed under different names according to their application: Regenafil and Regenafil RT allograft pastes are used to fill small gaps in bones of the maxillofacial area; Optefil and Optefil RT allograft pastes/syringes are used to fill gaps in bone; Osteofil and Osteofil RT DBM pastes are used as bone void fillers in cervical and lumbar procedures.

According to a company news release, each lot of DBM is tested in vivo using a rat assay to determine its capacity to facilitate bone growth.

Reviewed by Gary D. Vogin, MD