St Jude CE marks Penta neurostimulation lead; also approved in Australia
This article was originally published in Clinica
Executive Summary
St Jude Medical has CE marked its Penta surgical lead for neurostimulation therapy. The company has also obtained regulatory and reimbursement approval from the Australian Therapeutic Goods Administration (TGA) for the device. The lead is designed to treat chronic pain of the trunk and limbs and pain from back surgeries that have failed. It delivers mild electrical pulses to interrupt or mask the transmission of pain signals to the brain. Electrodes on the lead can be programmed to meet individual patients' needs. The St Paul, Minnesota-based company claims that the five-column surgical lead is the first of its kind, and features the smallest electrodes on the market. The Penta lead gained US premarket approval (PMA) last year (www.clinica.co.uk, 7 December 2009).