DyAnsys’ Primary Relief Gets FDA Clearance

The FDA has granted 510(k) marketing clearance to San Mateo, Calif.-based DyAnsys’ Primary Relief percutaneous electrical nerve stimulator (PENS) system for treatment of pain following cardiac surgery.

The device, which administers low-level electrical pulses to cranial nerves on the ear through a wire assembly and needles, can be used for up to three days for symptomatic relief of post-operative pain.

The system has been shown to reduce the need for opioid pain relievers after surgery. In one randomized study, participants treated with the PENS system needed just one-third of the fentanyl used for those who did not receive the nerve stimulation.

The device was previously cleared for use in post-Cesarean section delivery.