Core Insights - Elutia Inc. has initiated a clinical study for its EluPro™ product, aimed at collecting real-world patient outcome data in cardiac implantable electronic device (CIED) procedures [1][2] - EluPro is the first FDA-cleared antibiotic-eluting bioenvelope for use with CIEDs and neurostimulators, launched commercially earlier this year [1][3] - The study will enroll 100 patients and follow them for 12 months to assess clinical and patient-reported outcomes, focusing on complications such as infection and device migration [2][3] Company Overview - Elutia specializes in drug-eluting biomatrix technologies, aiming to improve compatibility between medical devices and patients [5] - The company’s mission is to humanize medicine, allowing patients to thrive without compromise [5] - The CIED protection market in the U.S. is valued at $600 million, with over 600,000 CIEDs implanted annually, and complication rates ranging from 5-7% [3] Product Details - EluPro combines antibiotics rifampin and minocycline with a soft, regenerative biomatrix, addressing critical needs in CIED procedures [3] - The product is cleared for use with all major CIED brands, including pacemakers and implantable defibrillators, as well as various neurostimulation devices [3]
Elutia Initiates EluPro™ Registry Study Designed to Generate Evidence Supporting the Use of EluPro in Real-World Clinical Practice