The Circulatory System Device panel of the FDA has recommended against approval of the CorCap Cardiac Support Device (CSD). This device was designed for patients with progressive heart failure, characterized by an enlarged heart and decreased pumping function. The FDA makes final decisions regarding approval, and is not bound to follow the recommendations of its panel advisors. The developer, Acorn Cardiovascular, is currently in discussion with the FDA regarding next steps.
The panel, made up of physicians, scientists, researchers, and consumer and industry representatives, reviewed scientific results from the Acorn Clinical Trial. Trial results suggested that the device provides sustained improvements in heart size, heart shape and quality of life, with a decreased likelihood of additional cardiac procedures such as transplants or ventricular assist devices. However, panel members requested further statistical evidence. The CorCap CSD is the introductory product of Acorn Cardiovascular, a privately held medical device company located in St. Paul, Minn.
"We are pleased that the panel was able to review the clinical data of the CorCap CSD for heart failure patients and are optimistic that we will be able to address their questions promptly and conclusively," said Rich Lunsford, Acorn Cardiovascular president and chief executive officer. "We will continue to work closely with the FDA to ensure that this innovative therapy can soon be made available to the many patients who could benefit from treatment."
The CorCap CSD is the first heart failure therapy specifically designed to address the problem of cardiac enlargement, which is a hallmark of heart failure progression. An enlarged heart becomes increasingly less efficient at pumping blood, leaving patients feeling tired and short of breath, often compromising even basic daily activities. The CorCap CSD is a proprietary, compliant mesh wrap that is implanted around the heart to provide gentle support to the heart muscle. By relieving stress on the muscle wall, the CorCap CSD is intended to improve the heart's size and shape, correlating with improvements in the patient's quality of life.
Patients participating in the Acorn Clinical Trial had symptomatic heart failure with enlargement of the heart and were being treated with optimal drug therapy, including beta-blockers and ACE inhibitors.
|
