Every year, new medical devices get approved by the FDA for use in the United States. But many times, these same devices were already approved for use in Europe and in other overseas countries years before. Why does it take so long for American patients to receive access to the same technology that patients in other countries already have?

 

According to Dr. Eduardo de Marchena, associate dean for international medicine at the University of Miami, there are a number of reasons that medical device approval lags in the U.S. “American trials are more rigorous; scientifically, they are probably a little superior to some of the trials required abroad,” he explained. “The process in the U.S. is also extremely risk-adverse, which makes the approval process arduously slow and extremely expensive.”

 

A device that makes it through the European regulatory system is given a CE (Conformite Europeena) marking, which provides its makers with access to the European Economic Area (EEA), consisting of 18 countries. “Because the approval system is a very long, very convoluted and extremely expensive process in the United States, even when a device is invented by an American, many of the companies that produce these products choose to do their early regulatory work abroad,” said de Marchena. “They want to achieve the CE marking so that they can sell the device in the rest of the world, possibly years before they get FDA approval to sell it in America.”

 

Drug eluting stents that are used for coronary artery angioplasty are one such device that was conceived of by an American physician, and received approval in Europe years before receiving FDA approval. “Another example is percutaneous valve treatments,” said de Marchena. “These were approved for general use in 2007-08 in Europe; the FDA approved one of the valves last year, but only for extreme risk patients who were completely inoperable otherwise.

 

“The second generation valve was approved in 2007 in Europe, but is still not approved for regular use in America,” he added. “It is in clinical trials now in the U.S. – that’s a five-year lag.” Other examples include mitral clip repair devices that have been in FDA trials for several years and renal denervation technology that has been approved abroad, but is only in the regulatory phase of U.S. testing.

 

In some cases, patients are sent overseas to take advantage of these technologies. “The patients who have been sent abroad had very little recourse for care in the United States,” explained de Marchena. “For whatever reasons, they did not fit into standard U.S. trials. While these technologies will be approved in the U.S. for wide-scale use eventually, if you’re a patient with the disease who is waiting, the process is way too slow.”

 

The length of the FDA approval process is making some medical device companies look overseas as well. “Some newer companies that are being formed are not banking on ever having U.S. approval,” said de Marchena. “Their budgets are based on overseas approvals only.

 

“The U.S. used to be a cash cow – there was a big payout for innovators who could get their technology to America,” he continued. “But as the economic structure changes, this is changing, too.”

 

De Marchena gives the example of CoreValve Inc., which received the CE marking and began selling valves around the world before being bought by Medtronic for $700 million. “This was one of the highest medical company purchases ever, and they never even stepped foot into the U.S. prior to being purchased,” said de Marchena. “This is the model that a lot of start-ups want to replicate.”