Cardiac Pathways: Mapping a Tough Course in EP
Cardiac Pathways' strategy is to develop solutions for the most difficult cardiac rhythm problems, those for which even palliative treatments are limited. Armed with promising advanced technology, the company was one of the last through the 1996 medical device IPO window but since then has been paying the price for being slow to market. With FDA approval finally in hand, along with new management and additional financing obtained at a premium cost, Cardiac Pathways hopes to sustain itself long enough to finally take advantage of its technological lead by creating a new market treating patients who have few other options.
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Atrial fibrillation (AF), once thought of as a benign condition affecting a relatively small patient population, has recently been found to be a major contributor to stroke and congestive heart failure (CHF), and is expected to afflict a much larger patient pool, particularly as the population ages, making AF one of the largest unmet cardiovascular clinical opportunities. The only current cure for AF is a traumatic, rarely performed surgical procedure. Palliative treatments are limited to drug regimens that are often ineffective and can produce serious side effects; or electrophysiology and cardiac rhythm management procedures that are only used for a relatively small number of patients. The size of the AF patient market and the recent discovery that AF is a precursor to stroke and CHF have elevated the condition in importance to product companies, making it one of the most competitive areas for the next generation of cardiovascular devices, and attracting interest from all the major cardiology companies, as well as many start-ups. AtriCure is developing novel technology that for the first time enables surgeons to ensure they are producing lesions that are transmural, meaning they completely penetrate the cardiac tissue. Transmural lesions have been shown to provide the only effective means of curing AF. The company's first-mover advantage puts it ahead of the pack, at least for now. AtriCure's challenge is to expand the application of its technology to avoid being marginalized when the inevitable rush of big and small players enter the market.
This month's $115 million cash deal to acquire electrophysiology company Cardiac Pathways Corp., makes five acquisitions for Boston Scientific already this year. Boston's dealmaking flurry is particularly notable given the relative inactivity of other large device companies on the acquisition front, and the cold shoulder the public market has given to the device sector. This deal reflects Boston's renewed commitment to electrophysiology, an area the company was thinking about exiting just a couple of years ago despite having a market-leading product. But it still remains to be seen whether this recent string of deals can turn around Boston Scientific and boost its flagging stock price.
Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.