Agency disagrees with device makers who see Europe as a model for product approvals.
All that remains of Steve Anderson's Acorn Cardiovascular sits in this 15 by 30 foot storage space in Little Canada. After raising $100 million from investors the FDA refused to certify his product which has been in use in Europe for years.
WASHINGTON - CorCap was a mesh bag that fit over the bottom of the human heart to treat congestive heart failure. Nobody questioned whether surgeons could safely install it. It sold in Europe for years.
But CorCap never got on the U.S. market for one reason: Its maker, Acorn Cardiovascular of New Brighton, could not convince the U.S. Food and Drug Administration (FDA) that CorCap worked better than drug therapy.
Today, Acorn Cardiovascular is out of business, despite $100 million in development capital. CorCap is no more.
In a new internal report obtained by the Star Tribune, the FDA claims the device's demise as a victory for American patients and an affirmation of the U.S. medical device approval process.
The strongly worded document details what the FDA says are 12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale in Europe but not the United States. It represents an FDA defense of its practices while industry groups, patient advocates and some in Congress propose changes in the way the agency does business.
"If a device gets on the market somewhere else first [and] it's a good device, good for them; if it's a bad device, bad for them," said Dr. Willam Maisel, FDA's deputy director for science. "The only way to know that is to look at some of the devices and see how they played out."
The report, "Unsafe and ineffective devices approved in the E.U. that were not approved in the U.S.," indicts a European system that American medical device makers, including hundreds of Minnesota companies, have held up as a model for getting lifesaving devices to market faster. It comes as Congress debates reauthorization of the Medical Device User Fee Act, the law under which devices are reviewed.
"We were anticipating questions about the type of data we ask for," Maisel said in explaining why the agency gathered the information. "This is the evidence."
Device recall expert Diana Zuckerman of the National Research Center for Women & Families said the report looks like FDA pushback against industry lobbying. "One of the big issues for lobbying is the device industry telling Congress that the system in Europe is so much better than the system in the U.S.," Zuckerman said.
The United States generally requires proof that high-risk medical devices benefit patients in "clinically significant" ways, while the European Union generally does not. The difference can mean years of expensive clinical trials.
The device industry contends that the FDA's slower approval of high-risk devices drives U.S. businesses overseas, costing high-paying jobs and keeping U.S. patients from badly needed relief.
"Nobody knows how to define clinically significant," said Acorn Cardiovascular founder Steve Anderson, whose company spent six years trying to prove CorCap's effectiveness. "We were burning more than $1 million a month just for personnel running the [clinical] trial."
Shay Mandle, vice president for government relations at industry group LifeScience Alley, said there are no data to suggest that people in the E.U. are getting more bad devices than in the United States.
"The E.U. system is working better today than the U.S.," said Mandle, whose group represents more than 600 medical technology businesses employing 250,000 people in Minnesota. "The rationale for most companies going to the E.U. is that it's more predictable."
University of Minnesota law professor Ralph Hall, who consults for medical device companies and studies the device industry, branded the unpublished FDA report "political." It is intended to deflect criticism from the FDA's performance and to neutralize legislation the FDA doesn't want, Hall said.
He called the report one-sided, looking only at E.U. failures. In some cases, the FDA went back more than 15 years to make its point, Hall said.
FDA critics in the House and Senate hope to add language to new-device legislation that, among other things, expands humanitarian exemptions for high-risk devices that require no effectiveness testing. Industry-driven measures also aim to change the FDA's mission statement to include job creation.
The report makes clear that the FDA does not want to move toward a more European approval model.
"Lowering standards of approval for devices in order to speed access can jeopardize patient health and impose high but often hidden costs," the FDA warns.
In the report, the FDA included a chart that compared approval standards. The agency says that the E.U. demands less evidence and allows private, for-profit companies to approve products for sale throughout the E.U.'s 27 member countries. Approvals and the evidence on which they are based are not disclosed publicly, the FDA said. Neither are side effects or recalls, the FDA says.
Others have questioned the European system. A February article in the New England Journal of Medicine reported that "a recent recall of a popular breast implant that was approved only in the European Union has reinforced European concerns about the clinical evaluation of high-risk devices."
Linda Alexander, who leads Alquest, a Minneapolis firm that helps device makers navigate the FDA, believes that the FDA prepared its report to boost staff morale.
Alexander said effectiveness testing is not as black-and-white as the FDA tries to make it. Annual recalls of risky medical devices are the same in the United States and the E.U., said Alexander, who worked 10 years for Minnesota device maker Medtronic.
"Companies are going to Europe in order to stay in business," she said. Selling devices in Europe often provides money manufacturers need to pay for clinical testing here.
Sen. Amy Klobuchar, D-Minn., and Rep. Erik Paulsen, R-Minn., have been especially vocal supporters of industry efforts to get medical devices to market faster.
Paulsen said in an interview that he favors effectiveness tests before allowing devices on the market.
"You should absolutely test for efficacy and safety, and I've never suggested otherwise," Paulsen said. "I've held up the European system as a model, not because it has a different standard, but because it is consistent, it's transparent, it's efficient and it's predictable. The U.S. system has become less so."
Klobuchar issued a statement: "I believe we can still make the approval process more efficient while increasing predictability, transparency and safety."
At least one Minnesota-made device awaiting FDA approval falls into a group that comes under severe FDA criticism in the report.
The agency blasted patent foramen ovale (PFO) occluders -- surgically implanted devices that close a congenital heart defect in stroke patients -- as no better than aspirin in preventing future strokes.
St. Paul-based St. Jude Medical Inc. sells its Amplatzer PFO occluder in Europe and other major world markets and hopes to sell it in the United States. The company just completed a major clinical trial but has not shared results with the FDA, said spokeswoman Amy Jo Meyer.
But a March 15 article and editorial in the New England Journal of Medicine reported results of a clinical trial involving another PFO occluder, the NMT StarFlex. It proved no more effective than aspirin in preventing a recurrence of strokes, researchers found. Worse, it caused a greater incidence of potentially harmful irregular heartbeats.
"During the nine years it took for the results of this trial to be reported," Dr. Claiborne Johnston of the University of California San Francisco Medical Center wrote in an editorial, "... $400 million was spent [around the world] on a procedure that had no apparent benefit, to say nothing of the clinical risks involved."
In an interview, Johnston said "the pendulum has swung too far" toward time-consuming FDA approvals, but that does not eliminate the need to measure product benefits.
"Society," he said, should not be "reimbursing for worthless devices."