Medtronic's Cardiac Reset Device Helps Heart Failure Patients
Medtronic's Cardiac Reset Device Helps Heart Failure Patients
Medtronic's Cardiac Reset Device Helps Heart Failure Patients
Medtronic Inc. device to synchronize the heart's pumping action helped slow the physical decline of heart-failure patients in a study that may boost use of the therapy in patients in early stages of the disease.
Adding, cardiac resynchronization, or CRT to a defibrillator reduced by 25 percent the risk of death or hospitalization from mild-to-moderate heart failure, compared with use of a standard defibrillator, according to a study reported at the American Heart Association meeting in Chicago.
The device, costing about $35,000, is approved for use in people with severe heart failure. Minneapolis-based Medtronic, the world's biggest maker of heart devices, plans to seek U.S. approval to expand use of its CRT-D devices in those with milder symptoms in the coming months, said Catherine Peloquin, a spokeswoman, in a Nov. 13,2010- telephone interview.
"We have demonstrated quite conclusively that this really does save lives and does improve longevity," said Anthony Tang, a researcher at the University of British Columbia in Vancouver and the lead author, in a telephone interview.
The U.S. market for implantable defibrillators, or ICDs, will grow just 1 percent in 2011, said Derrick Sung,a Sanford C. Bernstein & Co. analyst. Medtronic, based in Minneapolis, reported that heart-rhythm-device sales overall fell 8.3 percent to $1.23 billion in the fiscal first-quarter ended July 30. It does not break out revenue for the CRT-D device.
"The study could drive some incremental sales," said Rick Wiseman analyst at Leerink Swann in New York in a Nov. 8 interview. "It really feels like nothing clinically right now is going to seriously re-energize the ICD market again."
Six Million Patients
Nearly 6 million people in the U.S. have heart failure, when a weakened organ is unable to pump enough blood to fuel the body. The CRT-Ds, about the size of a small mobile phone, send electrical currents through wires to stimulate the heart's chambers to pump blood in unison.
Boston Scientific Corp., based in Natick, Massachusetts, gained U.S. approval in September to use CRT-Ds in patients with less advanced disease after a study found use of the devices reduced the risk of death or heart failure by 34 percent.
In the Medtronic study of 1,798 patients, 33 percent of those with the device died or required hospitalization for heart failure, compared with 40.3 percent of those who received a regular defibrillator. About 21 percent of the group with the Medtronic device died during the study, compared with 26 percent of the defibrillator patients.
Complications Found
Thirteen percent or 118 of 888 patients who received the Medtronic device suffered complications, compared with about 7 percent, or 61 of 898 of those in the standard defibrillator group, the research found. The most common complication was wires that dislodged or weren't working properly, Tang said.
The combined CRT-ICD devices, which require the implantation of an additional wire into the heart, have higher complication rates than standard defibrillators, said Rita Redberg, a cardiologist at the University of California, San Francisco, in a telephone interview.
"Even without considering the higher cost, you want to believe there is some additional benefit and that benefit is powerful enough to offset the higher risk of CRT implantation," Redberg said.
The research was also published online today in the New England Journal of Medicine.
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