Since last year’s society meeting, during which St. Jude announced Food and Drug Administration clearance to sell the device in the United States, St. Jude has received CE Mark approval to sell the device in Europe and reimbursement approval from the Australian Therapeutic Goods Administration.
The Little Canada device maker bills the five-column surgical lead as the first of its kind, having the smallest electrodes on the market. Because of its design and ability to deliver more electricity through smaller electrodes, the device may enable doctors to better manage patients’ chronic back pain after surgery has failed, the company said in a written statement.
“Early adoption of the Penta lead in the [United States] has been very promising, and we are encouraged by how well this paddle lead is aiding physicians in controlling low back pain,” Chris Chavez, president of the St. Jude’s Neuromodulation Division, in the statement. “We are excited to be able to make this first-of-its-kind product available to physicians in Europe and Australia.”
While the uninsured are pummeling the businesses of most medical device makers in the United States, St. Jude continues to make smart acquisitions that add to sales.
Known mostly for its pacemakers and implantable cardio defibrillators, St. Jude got into the neurostimulation business in a big way in 2005 when it purchased Advanced Neuromodulation Systems (ANS) in Plano, Texas. The smooth acquisition gave St. Jude a much-needed boost in revenue at a time when global demand for mechanical heart devices started to wane.
ANS also has helped St. Jude narrow the considerable lead of neurostimulation industry giant Medtronic Inc. Last year, St. Jude won European approval for its Libra deep brain stimulation device to treat Parkinson’s disease. It hopes to challenge Medtronic’s Activa devices in the United States. St. Jude is conducting clinical trials on a deep brain stimulation device to treat depression. And the company recently entered China and Japan.