Patients with St. Jude Medical Inc.’s Riata wires that connect life-saving defibrillators to the heart should get X-rays or other imaging tests to detect potential defects, U.S. regulators said.
St. Jude, the third-largest maker of heart rhythm devices, stopped selling Riata wires in 2010 and recalled them a year later amid reports they may break through the insulation used to coat the cables, called leads. The defect, found in as many as 1 in 4 of larger Riata wires, can lead to inappropriate shocks from a defibrillator or other devices used to regulate the heart. In some cases, the device may fail to provide a life-saving jolt of electricity when a patient’s heart stops.
“In the vast majority of patients, this is a life-saving therapy,” Bram Zuckerman, director of the Food and Drug Administration’s cardiovascular device division, said in a telephone interview. “This is an attempt by the agency to fully inform patients and practitioners of what the available data say so they can work together to provide optimum care for patients with these leads.”
The FDA is requiring the St. Paul, Minnesota-based company to conduct three-year studies on the Riata and Riata ST leads to pinpoint the amount of time it takes for the wires to breach the insulation and for the device to subsequently fail. The agency also has asked for similar studies on St. Jude’s newer Durata and Riata ST Optim devices, which use a sturdier type of insulation, to determine their long-term safety.
St. Jude fell 4.4 percent to $36.87 at the close in New York, the biggest decline in two months. The shares have dropped 15 percent in the past 12 months.
The devices shouldn’t be routinely removed from patients, even if they have broken through the coating, the agency said. Instead, tests should be run to determine if the wires still are working properly. Doctors and patients need to decide together the best course of action for those patients who devices have completely failed, since there are risks associated with the surgery required to remove the leads.
While St. Jude stopped selling the first Riata devices in 2010, there are about 79,000 implanted in American patients, the company has said. The number of patients with defective devices has been uncertain because routine imaging wasn’t recommended, the flaws are hard to detect with existing tests and failure may not occur until an electric jolt is needed.
St. Jude recognizes the FDA’s request for screening of all patients with Riata will lead to a better understanding about how often the wires protrude from the insulation, said Amy Jo Meyer, a company spokeswoman, in an e-mail statement. St. Jude has completed the first phase of a study looking at Riata’s performance and has the largest surveillance registries in the industry to monitor its products over time, she said.
“We welcome a continuing discussion with the FDA and physicians with respect to deciding how to manage individual patients,” she said. “Our goal is to provide physicians timely and relevant clinical data to best support their patient management decisions.”
The agency is trying to collect enough information to determine how a lead may progress from a “perfect” new device to one that may fail, said Mitchell Shein, branch chief for pacing, defibrillation and leads at the FDA. The timeline to an electrical failure is critical and better understanding the progression is in the interest of public health, he said.
The FDA will continue to monitor safety information provided to the agency and look for signs of worsening with Riata, Durata and other leads, Shein said in a telephone interview. The agency doesn’t know enough about the long-term performance of Durata and St. Jude’s newer leads, which are similar to the design of Riata, he said.
“Until we have a level of confidence in the longer-term performance, we think it’s appropriate to evaluate them prospectively,” Shein said.