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GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.