501k clearance for pain drug delivery deviceJune 9, 2019
Avanos Medical has received US FDA 501(k) clearance for its ON-Q with bolus pump.
The new ON-Q with bolus design incorporates improvements that make it simpler for providers and patients to use while reducing postoperative opioid use to achieve pain management.
The new ON-Q bolus provides customised control for patients recovering from post-surgical pain by delivering continuous, non-opioid medication to the surgical site or peripheral nerves for up to five days.
The bolus pump is ergonomically designed to fit comfortably in the patient’s hand with an easy to remove the priming tab and large level indicator markings. The device can also be used for incisional applications.
Studies have shown that using bolus rates as low as 3 ml in addition to the basal rate can reduce the total amount of anaesthetic needed for pain relief. ON-Q is indicated to significantly reduce opioid use for surgical patients and provide better pain relief than opioids alone, helping patients to get back to normal faster after surgery.