Elutia Inc. launched a clinical study to gather real-world data on patient outcomes using EluPro, its FDA-cleared antibiotic-eluting bioenvelope for cardiac implantable electronic devices (CIEDs) and neurostimulators. The study, enrolling 100 patients across multiple centers, will track clinical and patient-reported outcomes for 12 months following CIED implantation, focusing on complications like infection, hematoma, and device migration. The first patient enrolled at UC San Diego Health.
This study is crucial because it moves beyond controlled trials to assess EluPro’s effectiveness in diverse real-world clinical settings. Gathering data on patient-reported outcomes adds a valuable layer of understanding about EluPro’s impact on patient experience and quality of life. This information could influence clinical adoption and reimbursement decisions, potentially differentiating EluPro in a market with significant unmet needs concerning CIED complications.
The prospective, post-market study aims to evaluate EluPro’s performance in standard clinical practice. Data will be collected on various complications following CIED implantation. This study builds on the existing knowledge base for EluPro, which combines antibiotics (rifampin and minocycline) with a regenerative biomatrix intended to promote healing and reduce complications. The U.S. CIED protection market is estimated at $600 million, indicating a substantial opportunity.
The results of this study could significantly impact EluPro’s market position. Positive outcomes could lead to wider adoption by healthcare providers, potentially driving market share growth and establishing EluPro as the preferred choice for CIED procedures. The study’s focus on patient-reported outcomes could also strengthen Elutia’s position in patient-centric care. This data will be essential for future product development and refinement, potentially paving the way for broader applications of Elutia’s biomatrix technology.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
