This report originally appeared in the December 2009 issue of DOTmed Business News

Like a major 20th century war, one of the big battles in the medical device industry will tear through Europe before it ever involves the U.S. I'm talking, of course, about the fight over transcatheter heart valves, devices that can replace defective heart valves through a catheter procedure - no open-heart surgery required. The scrap for what could be a $1.5 billion market between Edwards Lifesciences, which offers the SAPIEN valve, and Medtronic, which vies for the CORE and Melody valves, even went mainstream and made it into the pages of The New York Times this October.

Transcatheter valves may be the next big thing, but outside of a handful of patients registered in U.S. clinical trials or granted compassionate use, only Europeans have so far benefited from them. Both SAPIEN and Medtronic's valves are still investigational devices in the U.S., and have no Food and Drug Administration clearance, while in Europe thousands of patients have had their new valve replacements threaded up their aortas.

This raises a question often asked in the medical device community: is Europe - or the rest of the world - just pushovers when it comes to approvals?

Where a device debuts rests on a complicated matrix of marketing decisions and regulation law that resists easy generalizations, although, in truth, quite often companies find that months, or even years, before they get U.S. approval, their products receive the CE Mark - an acronym of the French Conformité[<00E9>][<00E9>][<00E9>] Europé[<00E9>][<00E9>][<00E9>]enne- which confers the right to sell most medical devices in all 27 member states of the European Union, plus Norway, Liechtenstein, Switzerland and Iceland.

"If for instance, we have an ultrasound product," Mark Namaroff, a spokesman for Analaogic, a Peabody, Mass.-based imaging device maker, tells DOTmed News, "it's a lot easier from a regulatory perspective to sell products in Europe first before the U.S."

But Joe McGrath, a spokesman for the heart product division of Medtronic, the Minneapolis, Minn.-based device giant, is not so sure. "It's probably multi-factorial," he says. "The regulatory pathway for CE mark differs in some significant ways from the regulatory pathway in the United States. The requirements for clinical data to achieve CE mark are different. I can't say - I'm not sure how to characterize the difference. It is often the case that devices debut in Europe or other parts of the world outside the U.S. before they debut in the U.S."

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