Elutia Initiates EluPro™ Clinical Trial To Assess Safety And Performance In Patients Undergoing CIED Implantations And Neurostimulations

Elutia Inc. is a leader in drug-eluting biomatrix technologies and has announced its initiation of the EluPro™ clinical study, enrolling its first patient at UC San Diego Health. The study aims to gather real-world outcome data on EluPro, the first FDA-cleared antibiotic-eluting bioenvelope designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators. The product was commercially introduced earlier this year.

The prospective, multi-centre, post-market study is designed to assess EluPro’s effectiveness in standard clinical practice and performance in the diverse population of patients undergoing CIED implantation. It will monitor clinical and patient-reported outcomes related to complications such as infection, hematoma, device migration, lead dislodgement, and erosion. The study plans to follow 100 patients 12 months after implantation to generate a robust set of performance data.

Kimberly Mulligan, PhD, Vice President and General Manager of Cardiovascular at Elutia, said, "A commitment to improving patient care drives every innovation we pursue. With EluPro, we combined trusted antibiotics with a soft, regenerative biomatrix to protect the implant, facilitate implantation, and support healing. This study will allow us to collect data on these differentiating characteristics in real-world practice.”

With over 600,000 CIEDs implanted annually in the U.S. and complication rates as high as 7%, EluPro offers a novel solution by integrating antibiotics rifampin and minocycline with a regenerative biomatrix. EluPro supports every significant brand of CIED and neurostimulation products through its broad compatibility function, promoting healing and managing procedure complications linked to infection. The U.S. market for CIED protection is estimated at $600 million.