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Concerns voiced over FDA premarket testing of ICD connector systems
Manufacturers plan to introduce a new ICD connector system with a four-pole connector cavity.
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The impending rollout of a new implantable cardioverter defibrillator technology has prompted concern from some practitioners regarding the FDA’s premarket testing of the technologies, according to an editorial published in the New England Journal of Medicine.
According to the editorial, three major manufacturers will soon be releasing a newly designed ICD with a four-pole connector cavity. The concern, according to the editorial, is that the design “represents a substantial departure from current ICD connector systems,” which are designed to isolate the high-voltage terminal pins in separate cavities.
“The rationale for using separate connector cavities is to ensure adequate electrical isolation for the high-voltage shock pathway,” the researchers wrote in the editorial. “If high-voltage isolation is lost and a short circuit develops during therapeutic shock delivery, otherwise potentially lifesaving defibrillation may be ineffective. Moreover, short-circuiting in an ICD connector can be lethal.”
Previous problems
The researchers noted that an FDA official attending the Heart Rhythm Society’s 2008 Scientfic Sessions in May announced that the agency would not require the manufacturers to conduct premarket clinical testing of the new four-pole connector prior to its approval for routine implantation, opting instead to conduct post-market surveillance studies. The researchers also noted that in the case of Medtronic’s Sprint Fidelis leads, which were voluntarily recalled by the manufacturer in October 2007 after reports of fractures and five deaths, the FDA had approved the device for sale and implantation after examining data from bench testing and animal studies instead of clinical trials.
A response from the FDA, cowritten by Daniel G. Schultz, MD, director of the agency’s Center for Devices and Radiological Health, was published in the same issue of the New England Journal of Medicine.
“The FDA has made no absolute decision that all implantable leads with IS-4 connectors will not require new clinical data,” the response said. “When we are evaluating an application for a modification of a device, our questions are sometimes best answered by appropriate engineering analyses and often through the use of clinical data.”
The HRS also released a statement in response to the FDA and to the editorial, which reiterated its position on device reliability and safety.
“The HRS is committed to the highest standard of safety,” N.A. Mark Estes, MD, president of the HRS, said in the statement. “We have been at the forefront of establishing policies and guidelines to ensure the safety of lifesaving devices such as internal cardiac defibrillators and pacemakers. The society will continue to develop standards as technology continues to evolve.” – by Eric Raible
For more information:
- N Engl J Med. 2008;359:2517-2519.
- N Engl J Med. 2008;359:2610.