St. Jude Medical (NYSE:STJ) says it’s won approval to begin selling its Athena deep brain stimulation programming device Down Under.
The approval from the Australian Therapeutic Goods Administration comes four months after the St. Paul, Minnesota, company’s product won CE Mark designation from regulators in Europe, where the device is currently being rolled out as part of a suite of deep brain stimulation (DBS) products aimed at treating the symptoms of Parkinson’s disease.
The Athena programmer is a nine-inch (22.6 cm), touch-screen tablet PC that lets clinicians set or adjust deep brain stimulation parameters, as well as store and organize patient data. Database features include an ability to save session data for up to 1,000 patients with 200 sessions for each patient. Information can also be exported for analysis, printing, e-mailing or importing into electronic medical records.
The programming device works with St. Jude’s Libra, LibraXP and Brio DBS systems, all of which are also approved in Australia and Europe. St. Jude entered the DBS market in January 2009 with the European approval of its Libra and LibraXP systems. Its Brio rechargeable stimulator was launched in September 2009. The devices look and function like a cardiac pacemaker, but instead of regulating heart rhythm, they send electrical stimulation to parts of the brain associated with Parkinson’s symptoms.
The products are part of St. Jude’s $330 million per year and growing neuromodulation business, which accounted for 7.1 percent of the company’s net sales in 2009. The unit has reported year-over-year growth in each of its first three quarters in 2010. In the fourth quarter, it started a full commercial launch of a suite of deep brain stimulation products, including the Athena programmer, in Europe.
St. Jude CEO Dan Starks spoke highly of the products’ potential during the company’s third-quarter earnings call in October, estimating the market size for Parkinson’s treatment to be $500 million. The company has only one key competitor, he said, and it expects to gain “meaningful market share in this new growing market.” The company reports fourth quarter and year-end earnings on Wednesday.
The Australian medical market is growing in importance following a major healthcare reform plan passed in November 2008. The Australian medical device market was worth $2.3 billion in 2009, and it’s expected to grow to an estimated $3 billion by 2012, according to a July 2010 report by Frost & Sullivan.
St. Jude Medical expects to publish data from a U.S. pivotal clinical trial during the first half of 2011.