There’s a “potentially troubling gap” in the Food & Drug Administration’s oversight of medical device clinical trials, according to the Wall Street Journal — the federal watchdog agency doesn’t inspect device-making plants during trials.
The Journal, citing the failed clinical trial of an Aptus Endosystems Inc. stent graft, said the lack of oversight means “hundreds of participants in clinical-trial studies of medical devices may be at risk of receiving faulty devices.”
Twenty-eight percent of the 177 patients in the trial developed blood clots in their legs or in the grafts, with several requiring emergency surgery or stenting. Doctors involved with the study >told the newspaper that manufacturing defects, not the design of the device, caused the problems with thromboses:
“The FDA didn’t inspect or audit the plant where the devices were made before they were placed in the aortas of more than 175 study participants, according to information from Aptus and from presentations at medical conferences.”
“An FDA spokesman declined to comment on the Aptus case. In response to questions, the FDA said it inspects manufacturing sites when companies apply for agency marketing approval, but declined to answer questions about the earlier clinical-trial stage.”
Aptus CEO Jeff Elkins told the business journal that the FDA never inspected his plant during the clinical trial, which was stopped after Stage II.
“[n]othing I’ve ever been involved with has had an FDA inspection” at the clinical-study stage, Elkins told the newspaper. “I’ve never had an audit before the time of the [marketing-approval] filing. Companies have been self-policing.”
Dr. Manish Mehta of Albany Medical Center in New York, a co-director of the Aptus study, called the rate of complications “extremely unusual,” according to the Journal.
“This was a very big deal,” Mehta told the newspaper. “This had a big impact on patients.”
Here’s a roundup of other recent clinical trial news:
- NxStage: NEJM study documents “significant clinical advantages” of frequent hemodialysis
NxStage Medical Inc. (NSDQ:NXTM) said a study, published in the New England Journal of Medicine, showed that short daily dialysis resulted in significant improvements in both of the study’s co-primary endpoints, a composite of mortality and change in left ventricular mass (as measured using cardiac magnetic resonance imaging) and a composite of mortality and physical health (as measured using the Rand 36-item health survey). In addition, the Trial demonstrated that short daily dialysis was associated with improved control of hypertension and hyperphosphatemia.
- OrbusNeich touts studies comparing Genous stent with bare-metal stents
OrbusNeich today announced that data from two studies demonstrate that the Genous stent increases endothelial coverage and reduces thrombogenicity as compared to bare metal stents by enhancing the specific binding of CD34+ endothelial progenitor cells.
- Air flows in mechanical device reveal secrets of speech pathology
Researchers from George Washington University in Washington, D.C., and the University of Waterloo in Toronto built a mechanical model of human vocal folds. The model shows how asymmetrical airflow impacts normal and diseased vocal fold motion.
- U.S. death rate from congenital heart defects continues to decline
The U.S. death rate from congenital heart defects dropped 24 percent from 1999 to 2006 among children and adults, according to research reported in Circulation: Journal of the American Heart Assn.
- Catheter ablation improves atrial fibrillation symptoms compared with drug therapy
Patients with atrial fibrillation showed improved symptoms and quality of life when treated via catheter ablation, when compared with drug therapy, according to the Circulation Cardiovascular Quality and Outcomes and Biosense Webster Inc.
- Implanted devices as effective in “real world” as in clinical trial settings
Implanted devices that treat cardiac dysfunction in heart failure patients are as successful in “real world” use as they are in controlled clinical trial settings, according to a large new study reported in Circulation: Journal of the American Heart Assn.
- Pathfinder initiates minimally invasive surgical navigation study
Pathfinder Therapeutics Inc. initiated a clinical study to assess the value of Explorer, its image-guided surgical platform, in minimally invasive liver resections and ablations. Clinical sites participating in the study include: Memorial Sloan-Kettering Cancer Center, University of Pittsburgh Medical Center, Providence Portland Medical Center and UNC-Chapel Hill.