a05dd90e-3431-4f6e-a16a-d0b133978d33UpdatePublished32025-12-172024-09-06In Commercial Distribution00859389005331PrimaryGS110859389005338PackageGS1008593890053315In Commercial DistributionBoxEluPro Antibiotic-Eluting BioEnvelopeCMCV-124-MED080924060Elutia Med LLC1The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.falsefalsefalsefalsetruetruetruefalsefalsetruefalsefalsefalseMR Safetruefalse35273Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.trueActiveFTMMesh, SurgicalDevice Size Text, specifyMediumStorage Environment Temperaturetruefalse