Patients who underwent surgery to repair punctured arteries had a significantly higher risk of complications when surgeons used a vascular-closure device manufactured by Cardinal Health, compared to an alternative device, according to a study published in The New England Journal of Medicine.
For the study, researchers compared surgical outcomes of more than 70,000 patients undergoing surgeries with either the Mynx vascular-closure device — approved by the Food and Drug Administration in 2007 — or an alternative device . The surgeries involved physicians cutting into the femoral artery in the thigh to clear blocked blood vessels or other procedures. The data was gathered from the National Cardiovascular Data Registry. A comprehensive computer analysis revealed the Mynx system to be 59 percent more likely to produce vascular complications like blood clots or access-site bleeding. The likelihood of a complication arising during surgery was 1.2 percent for the Mynx system versus 0.8 percent for other approved devices.
Jon Resar, MD, and Myron Weisfeldt, MD, with Johns Hopkins University School of Medicine in Baltimore, argued the FDA should issue an alert to physicians regarding the higher levels of risk associated with the Mynx system, in an editorial published in The New England Journal of Medicine in tandem with the study.
"Patient safety is our number one priority. We have data that supports the safety and efficacy of our vascular-closure devices. We stand behind our products," Cardinal Health said in a statement in response to the study and accompanying editorial, according to Reuters Health.
The study suggests closer monitoring of medical device performance would likely reveal more problems with the devices than previously recognized, according to Reuters Health.
"We're like ostriches with our heads in the sand when it comes to medical devices," Frederic Resnic, MD, director of the cardiac catheterization lab at Brigham and Women's Hospital in Boston, told Reuters Health. "We know they work well in trials under highly controlled circumstances. Then we make them available to everyone and then we never look again. We only find out about problems when they blow up into enormous issues."
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