Health Highlights: March 29, 2008

A report presented Saturday at a joint cardiology meeting in Chicago, sponsored by the American College of Cardiology (ACC), found that medical centers with "well-organized, highly skilled" PCI programs can safely and effectively perform the angioplasty.

Researchers compared 9,029 patients who had angioplasty at 61 centers without cardiac backup surgery to 299,132 patients at 404 centers with a cardiac surgery program from January 2004 through March 2006. And they found there was no statistical difference in mortality.

According to a news release from the Society for Cardiovascular Angiography and Interventions, the findings should not be interpreted as an endorsement of "boutique angioplasty." Lead investigator Dr. Michael A. Kutcher, of Wake Forest University in Winston-Salem, N.C., said, "These medical centers are doing angioplasty for the right reasons: to improve outcomes for heart attack patients and to better serve patients in remote geographic areas."

The findings represent the largest clinical study ever to compare PCI programs that have on-site cardiac surgery to PCI programs that transfer patients to a surgical hospital in case of emergency, according to the SCAI news release.

PCI involves threading a slender balloon-tipped tube from an artery in the groin to the clogged place in the coronary artery. By inflating the balloon, the vessel-clogging plaque is compressed, allowing better blood flow.

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FDA Seeks $2.2 Million Penalty from Hearing Aid Maker

Hearing aid maker Advanced Bionics LLC is being penalized $2.2 million by the U.S. Food and Drug Administration for alleged violations including failing to adhere to manufacturing standards and for failing to notify the agency that it had changed suppliers, the FDA said Friday.

The Sylmar, Calif., company makes a device called the HiRes90k Implantable Cochlear Stimulator. The device is surgically implanted behind the ear to treat profound hearing loss in both adults and children.

The agency's legal complaint alleges that the company exposed device users to unnecessary health risks by failing to follow standard manufacturing procedures and by distributing devices that contained a component provided by an unapproved vendor.

The complaint says Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. At least some of the alleged violations occurred after a 2001 inspection, which had found similar failures that the company had promised to correct, the agency said.

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