FDA clears antibiotic-eluting bio-envelope to reduce complications after ICD implant
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Key takeaways:
- The FDA cleared an antibiotic-eluting envelope to reduce complications after pacemaker or defibrillator implant.
- The envelope is designed to mitigate long-term foreign body response and reduce infection risk.
Elutia Inc. announced the FDA clearance of its antibiotic-eluting bio-envelope designed to prevent postoperative infection, migration and erosion for implanted devices such as pacemakers and defibrillators.
The bio-envelope (EluPro) is designed to circumvent the long-term foreign body response with a combination of drugs and a natural extracellular tissue matrix designed to support regeneration of a vascularized pocket from the patient's own tissue, according to a company press release.
The walls of the envelope are embedded with the antibiotics rifampin and minocycline, which are delivered over an extended period long after surgical site closure, according to the release.
The company also announced the bio-envelope was granted clearance for indications such as neurostimulators, neuromodulators, pain management, epilepsy, incontinence and sleep apnea.
“When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” Benjamin D’Souza, MD, FACC, FHRS, associate professor of medicine at the University of Pennsylvania and section chief of cardiac electrophysiology at Penn Presbyterian Medical Center, said in the release. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.”
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