FDA CLEARS NEW INDICATION FOR ACCUFUSER PUMP

The FDA has granted a premarket notification clearance to McKinley Medical allowing the company to market its Accufuser Post-Op Pain Control Pump for use in significantly decreasing the use of narcotic pain medications following surgery.

The device is a portable, non-electronic balloon infuser that delivers continuous infusion of local anesthetic through a special catheter to the site of the surgery. While wearing Accufuser, patients can press a bolus button to receive additional doses of non-narcotic medication to enhance their comfort. It is also made entirely of non-latex materials, allowing for the device to be lightweight enough so patients can use it anywhere they go following general, orthopedic, aesthetic/plastic and other surgical procedures.

This most recent FDA clearance follows three previous 510(k)s clearing McKinley Medical to market the Accufuser pump for postoperative pain management and regional anesthesia.