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Saga of the heart sock continues

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I’ve been tracking news coverage of a Minnesota company’s heart “sock” device for heart failure for four years. Four years ago, I questioned Star Tribune coverage.

Two years ago, questions of evidence started to surface.

Today the Star Tribune reports:

“The high-profile consumer advocacy group Public Citizen expressed “deep concern” this week about whether the company’s experimental device has been sufficiently reviewed by federal regulators. …

Two advisory panels for the FDA have recommended against approval of the Acorn device after reviewing the company’s application and holding public hearings. The agency itself has rejected the company’s application three times. Acorn has even taken its case to a dispute resolution panel, a highly unusual move in the device world, which also voted against approval of its device.

Normally, a company in this situation would have abandoned the rather-expensive effort, especially a start-up like Acorn, which has no other products on the market.

But Acorn has been encouraged along the way by Dr. Daniel Schultz, a surgeon who is head of the FDA’s device division, and the company subsequently reached an agreement with the agency to conduct a second, albeit smaller, clinical trial involving 50 patients. If that study is successful, the device could be approved by the agency without being first reviewed by an advisory committee and without a public hearing, according to Public Citizen.

In a Nov. 12 letter to Schultz, Public Citizen said the design of the new study “is so poor that it is unlikely to provide reliable data that would contradict the negative findings of the data so far submitted to the FDA.” The number of patients enrolled in the study is too small, and they will not be followed for a sufficient amount of time, Lurie said.”

I never would have picked up on the scent of this story had not the Star Tribune given such favorable coverage to the company and its product four years ago.

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