By Catherine Arnst
While poets and lovers ponder how to mend a broken heart, doctors now have a tool for repairing an enlarged heart. One of the more unusual medical devices yet developed, a mesh "jacket" can actually reverse this dangerous condition. It's called the CorCap Cardiac Support Device -- and it's one of the notable successes at the American Heart Assn.'s annual Scientific Sessions, being held this week in New Orleans.
Medical researchers told the gathering on Nov. 7 that in a 30-month clinical trial involving 300 patients, the CorCap demonstrated sustained improvements in heart size and shape, produced significant quality-of-life improvements, and reduced the number of additional medical procedures by 50%.
"This is a fantastic device," said Dr. Douglas L. Mann, a cardiologist at Michael E. DeBakey Veterans Affairs Medical Center in Houston and lead investigator of the CorCap trial. "I think we can make a significant impact on these patients."
Artist's view of the CorCap Cardiac Support Device
WORKING TOO HARD.
CorCap is the first product of Acorn Cardiovascular, a tiny privately held company in St. Paul, Minn., started in 1996. Essentially, the device is mesh bag created from a type of polyester commonly used in implants. It's fitted around the heart during surgery and sewn into place, where it remains permanently.
The device is the first attempt to directly remedy progressive heart enlargement, an underlying condition of heart failure, which affects about 5 million people in the U.S. each year. About half of these patients develop oversize, dilated hearts as the organ tries to compensate for reduced pumping ability by growing larger. The heart changes in shape from a football to a basketball, and this growth, known as "left ventricular remodeling," can lead to irregular heart beats.
By giving the heart some extra support, the CorCap stabilizes the organ and keeps it from working so hard. Mann said half the patients in the 300-patient trial received the device, and 77% of that group showed improvement in quality of life. Since 1999, 315 of the devices have been implanted, and no problems have shown up over four years of follow-up, he added.
Acorn will use the trial as the basis for an application for approval to the Food & Drug Administration, which it expects to file in the first quarter of 2005, an Acorn spokeswoman says. The company has not yet priced the device.
Arnst is a senior writer for BusinessWeek