Industry Briefs

MRI-Safe Peripheral Neurostimulator Given Green Light by FDA

Stimwave LLC announced last week that its StimQ Peripheral Nerve Stimulator (PNS) System has received Food Drug Administration (FDA) 510(k) clearance.

The system, which can be implanted during outpatient surgery for chronic peripheral pain, provides pain relief by delivering small pulses of energy to electrodes placed at a peripheral nerve.

The FDA clearance permits patients implanted with a wireless neurostimulator to undergo full-body MRI scans without removing the implant. This is an important consideration as people with chronic pain typically have routine diagnostic MRIs.

FDA Panel Recommends Against Opioids That Release Blue Dye When Abused

An FDA advisory panel voted 22-1 last month against approving Rexista (abuse-deterrent oxycodone hydrochloride extended-release) tablets from Intellipharmaceutics International that featured a unique abuse deterrent: the release of a deep-blue dye when someone tries to improperly use the medication via crushing, chewing, or snorting the pills.

The highly visible and difficult-to-remove blue dye was meant to discourage abuse and warn others about potential abuse, the company stated; however, the panel raised many concerns about the dye’s safety for intended patients. The panel also raised concerns regarding its effectiveness at discouraging abuse. Some panelists suggested that blue stains around the mouth or nose could become popular among those with substance use disorders.

The panel also voted that Intellipharmaceutics had failed to demonstrate that the medication could effectively deter abuse by injection. ■