A study published last week in The New England Journal of Medicine concluded that patients treated with Cardinal Health (NYSE:CAH)’s Mynx vascular closure device are at higher risk for vascular complications compared to patients that received alternative vascular closure devices. The data also suggested that patients who received the Mynx device were at greater risk for access site bleeding and transfusion compared to their counterparts.
The team of researchers analyzed data from 73,124 patients who received Mynx devices after percutaneous coronary intervention procedures with femoral access from January 1, 2011, to September 30, 2013.
Using data from the CathPCI Registry of the National Cardiovascular Data Registry, the authors set the primary outcome as any vascular complication, which included access-site bleeding, access-site hematoma, retroperitoneal bleeding and any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.
The study, which was funded partially by the FDA, aimed to evaluate the real-word performance and safety of the Mynx device, which is designed differently than alternative vascular closure devices. The Mynx device delivers a polyethylene glycol gel to the surface of the artery, without using mechanical anchoring. Other devices employ a variety of mechanical and biomaterial components to speed up hemostasis by sealing the arteroitomy site.
“Early identification of real-world differences in clinical performance among medical devices may provide opportunities to support iterative improvements in device design and complement traditional premarketing evidence to refine the selection of patients and improve the training of providers,” the authors wrote. “Active surveillance of medical-device safety, through the continuous monitoring of large clinical-data sources, has been proposed to address these limitations and has been identified as a priority by the Food and Drug Administration.”
The case originally resulted in a 2-year suspension of the company’s registration to distribute controlled substances from its Lakeland, Fla.-based distribution center, Dublin, Ohio-based Cardinal Health said.