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.

Physicians have long theorized that being able to precisely warm and cool patients, depending on their conditions and settings, would be beneficial in both cardiovascular and neurological procedures, and recent clinical evidence has shown temperature management to be even more important than initially thought.Medivance is looking to develop a non-invasive external temperature management system that is both simple to operate and suitable for a variety of settings for both precise warming and cooling. The company believes an external device avoids the risk of an invasive procedure and can be used easily by neurologists, who generally aren't comfortable inserting catheters.In striving to solve a difficult technology problem (external, non-invasive temperature management) with an easy-to-use device, Medivance is looking to avoid a problem that plagues many device companies--falling in love with complex, hard-to-operate technology. While a very sophisticated device may work effectively, a steep learning curve inhibits broad adoption because physicians are notoriously reluctant to adopt new technology unless it closely resembles current techniques. Medivance's system enables an anesthesiologist to regulate patient temperature without intruding on the surgical field and without heating up the OR, a win-win for surgeons.

The boom times are over in devices. Now venture capitalists vow to focus more on business fundamentals. Entrepreneurs say the same, while they increasingly seek start-up money from private investors known as angels.

RF-devices for open and minimally-invasive surgery