The U.S. Food and Drug Administration (FDA) has ordered a medical technology company to understand the cause and extent of failures of its heart-device components that have been linked to as many as 20 deaths.
FDA says that St. Jude Medical needs to conduct studies to find out why its Riata defibrillator leads, which were recalled last December, fail at an unacceptable rate. The agency also requested that the company conduct further studies on its newer Durata series leads. Although these latter leads have not been recalled, the FDA warned that the two devices are similar, reports Christopher Weaver of The Wall Street Journal.
Leads connect a heart to defibrillators, which are implantable devices that shock the heart with electrical pulses to correct irregular heartbeats. Wires in Riata leads had a history of breaking with unusual frequency: by 19% in more than 700 patients, a study conducted by St. Jude found. The company stopped selling the leads in late 2010. About 128,000 people worldwide still use the Riata leads, according to The New York Times.
St. Jude says that it supports further study of the Riata leads. It will work with the FDA “to understand the ongoing performance of our leads and the initiation of any additional studies.” The company also collected Durata performance data. It has highlighted differences between the two, noting design changes and a new coating to improve the integrity of the insulation.
Still, the FDA wants more data, even though it is aware of the company’s studies. “The FDA is looing for a very thorough investigation of the problem,” says Bran Zuckerman, chief of cardiovascular devices at the agency. The FDA “wanted to make sure this is done at the present time,” he says.
The agency wants to ensure that the problems with the Riata leads do not creep into other St. Jude products. The agency is asking that the company routinely X-ray patients enrolled in post-market Durata studies to detect any potential insulation problems, for example.
The Durata lead is “sufficiently similar” to the recalled Riata products, the FDA says. “We don’t have enough long-term performance data to be sure it won’t have this problem,” says Mitchell Shein, FDA’s branch chief for pacing and defibrillation devices.
Source: “FDA Orders Review of Heart Devices,” The Wall Street Journal, 8/16/12
Source: “St. Jude is Told to Study a Defect in Heart Devices,” The New York Times, 8/16/12
Image by Gregory Marcus.
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.