- Elutia (ELUT, Financial) launches a real-world clinical study for EluPro™, tracking 100 CIED patients over 12 months.
- The study aims to address complication rates of 5-7% in a $600 million U.S. market.
- EluPro™ combines antibiotics with a regenerative biomatrix for CIED protection.
Elutia Inc. (ELUT), a pioneer in drug-eluting biomatrix technologies, has initiated a real-world clinical study for its FDA-cleared EluPro™ bioenvelope. This innovative solution is designed to enhance the safety and efficacy of cardiac implantable electronic devices (CIEDs) and neurostimulators. The first patient enrollment took place at UC San Diego Health as part of this multi-center, prospective study.
The EluPro registry study will follow 100 patients over a 12-month period to evaluate the product's performance in standard clinical practices. Key complications of interest that will be monitored include infection, hematoma, lead dislodgement, and device migration. These factors contribute to the 5-7% complication rate observed in the annual implantation of over 600,000 CIEDs in the U.S.
By combining antibiotics such as rifampin and minocycline with a regenerative biomatrix, EluPro offers a differentiated approach compared to synthetic alternatives, aiming to reduce the risk of infections and other complications. The CIED protection market in the United States is valued at approximately $600 million, and EluPro's unique status as the first and only FDA-cleared antibiotic-eluting bioenvelope could support significant commercial potential if the study yields positive outcomes.
