The Pacemaker's Continuing Evolution: St. Jude Looks at New Apnea Therapy
This article was originally published in Start Up
The pacemaker is the ancient warhorse of the cardiac rhythm management business--45 years old and still ticking. One reason: companies keep improving and finding new uses for it. Along with treating arrhythmias, the major CRM companies have adapted pacemakers to become part of an increasingly successful device-oriented approach to treating congestive heart failure. And now St. Jude Medical is the first CRM company to begin a clinical trial investigating whether pacemakers may be an effective treatment for sleep apnea.
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Sleep is getting a lot of attention in the clinical community these days, and in particular, interrupted sleep. The obstructive sleep apnea market for treatment, monitoring and diagnostic products is forecast to grow at an almost 13% compound annual growth rate through the year 2010 based on only incremental changes to existing diagnostic and treatment modalities, according to "US Markets for Blood Gas/Electrolyte Monitoring, Pulmonary Function Assessment, and Sleep Apnea Management Products," published in December 2005 by Medtech Insight. But the field is beginning to see an influx of new kinds of treatments from both the medical device and pharmaceutical industries as well.
In the early 1990s, St. Jude Medical was the market leader in its sole product area: mechanical heart valves, which placed it among the most profitable of device companies. Demographics, however, limited heart valves' future growth opportunities and St. Jude needed to diversify, moving into cardiac rhythm management (CRM), cardiology catheters, and vascular access devices, while also expanding in cardiac surgery. The diversification process went anything but smoothly, the company missed its numbers, and investors were quick to punish St. Jude for its integration missteps. In the past year, however, the company has become one of Wall Street's few device darlings, ranking number one in 2000 for returns among device stocks. The company's growth is largely the result of sticking to a strategy that has St. Jude well-positioned in CRM's traditional markets, while also poised to pursue huge new opportunities in atrial fibrillation and, to a lesser degree, congestive heart failure. And St. Jude has not forgotten its base: cardiac surgery, where the company has introduced new sutureless anastomotic technology for minimally invasive coronary bypass surgery.
Long viewed as simply annoying habits, sleep disordered breathing (SDB) problems like snoring are, in fact, often symptoms of more severe conditions, most commonly obstructive sleep apnea (OSA). New clinical evidence is confirming the theories of early sleep medicine physicians that, in addition to causing snoring, headaches and excessive daytime sleepiness, OSA leads to severe cerebro- and cardiovascular complications, including hypertension, stroke, heart attack and sudden cardiac death. Studies are also revealing that SDB problems are extremely widespread, afflicting an estimated 40 million Americans, yet only a small percentage of those are diagnosed and treated. Very few patients are ever cured because the traditional surgical procedures that can eliminate OSA are extremely traumatic and often don't work. ResMed is fighting a two-tiered battle in attempting to develop and market devices to effectively treat OSA: first is getting patients to acknowledge and physicians to diagnose and treat this condition, and second is designing a device that is sufficiently patient-friendly to overcome what has been the Achilles heel of OSA treatment: poor patient compliance.