Dr. John Catanzaro of the East Carolina University Health Medical Center in Greenville, North Carolina, performed the first procedure. Elutia says this marks the first implant of the world’s first antibiotic-eluting biologic envelope.
Elutia designed EluPro to prevent post-operative complications in patients with implantable cardiac devices. Those include pacemakers and internal defibrillators. The system received FDA clearance in June 2024 and also has approval for use with additional devices. That extends to neuromodulators and neurostimulators for pain management, epilepsy, incontinence and sleep apnea.
According to the company, the launch of EluPro presents a “major opportunity” in what it considers to be a $600 million market for protecting implantable electronic devices in the U.S. Previously, a single competitor with a synthetic envelope served this market, Elutia says.
“We are honored to be the first facility to implant EluPro,” said Dr. Catanzaro. “With its combination of proven antibiotics and biomatrix with demonstrated regenerative benefits, EluPro offers a more natural solution to reduce post-operative complications. This is a significant advancement in patient care, providing enhanced protection and peace of mind for patients needing a pacemaker or defibrillator.”
Elutia says the milestone demonstrates its ability to deliver on its commitment to advancing healthcare.
“Our mission is to humanize medicine so patients can thrive without compromise, and today, we made significant progress toward fulfilling that promise,” said Dr. Randy Mills, Elutia CEO. “Today’s milestone is a testament to the team’s relentless pursuit of better patient outcomes and I want to thank the entire Elutia CRU. With EluPro, physicians finally have a biologic antibiotic-eluting envelope to protect their patients, and we look forward to its full commercial launch in January 2025.”
