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FDA Support of Heart Device Would Fly in Face of Sound Science

Nov. 13, 2008

FDA Support of Heart Device Would Fly in Face of Sound Science

Information Currently Being Collected on Heart Sock Unlikely to Contradict Existing Unfavorable Data

 WASHINGTON, D.C. –A new clinical trial of a cardiac device that Food and Drug Administration advisory panels already have rejected is unlikely to yield convincing data, Public Citizen said in a letter sent today to the director of the FDA’s Center for Devices and Radiological Health.  

Acorn Cardiovascular Inc.’s CorCap device is a mesh support sock sewn around the heart during open-heart surgery for dilated cardiomyopathy, a form of heart failure in which the heart becomes enlarged. The device seeks to limit further enlargement of the heart. Following the only clinical trial done on the device, two FDA advisory panels recommended against the device’s approval, as did the FDA, itself, on three occasions.

Despite these rejections, the FDA has counseled Acorn how to conduct a new study and to submit another pre-market application for CorCap, potentially leading to approval without further advisory committee review.

“We are extremely concerned that the FDA may approve a device that a study has failed to demonstrate is safe or effective,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “In the only significant study of CorCap done to date, the device failed to help patients with enlarged hearts and put them at risk for surgical scarring and heart constriction.”

The FDA has suggested that it could approve CorCap based on the results of the new trial. But the new trial, with only 50 CorCap patients, is too small and would not last long enough to provide convincing data, Lurie said. Moreover, it does not have an appropriate control group and investigators will know that the patients have received CorCap, thus potentially introducing bias into the study.

“The proposed clinical trial is so poorly constructed that it is unlikely to provide any meaningful data to contradict the negative findings of the first study,” said Eunice Yu, a research associate with Public Citizen. “Subjecting more patients to an experimental therapy that has little hope of producing meaningful data is irresponsible.”

If the FDA approves the device without further advisory committee scrutiny, the move would be a clear abdication of the FDA’s role to protect the public based on sound scientific evidence, the letter said.