Role of Elutia's BioEnvelope for CIED Implants: Reducing Complications through Regenerative Medicine

@Elutia
Humanizing Medicine
www.elutia.com
There are approximately 500,000 CIED procedures in the US each year. Some of these patients will experience complications related to the inflammation and scar formation of a foreign body response. By harnessing the power of regenerative medicine, Elutia’s BioEnvelopes may reduce some of these complications while making patient care more predictable and manageable.
Whenever device is implanted, the body recognizes it as an injury and signals a foreign body response. Monocytes are deployed to the area. These monocytes recognize the device as foreign and transition into pro-inflammatory M1 macrophages. This initiates scar proliferation, which typically results in a fibrotic capsule. This fibrotic capsule is associated with reduced vascularization of the pocket and potential long-term complications. Now there's another way.
Extracellular matrix or ECM is the complex environment surrounding all cells. ECM contains collagen, structural proteins and growth factors, and regulates cellular behavior. Elutia’s BioEnvelopes are constructed from ECM, derived from porcine small intestine submucosa or SIS, and is designed to stabilize an implantable device to mitigate migration and erosion.
When a device is implanted with an Elutia BioEnvelope, monocytes are deployed. Upon contact with the ECM material, the immune response redirects inflammatory M1 macrophages to transition into anti-inflammatory M2 macrophages seen in blue. As a part of the regenerative healing cascade, cells populate the SIS ECM. Several growth factors and antimicrobial peptides are released and new blood vessels are formed.
Once remodeling is complete, the result is newly formed, systemically connected healthy tissue surrounding the device, which helps to provide long-term protection naturally. Stabilization is achieved protecting the device from migration and erosion.
Without the Elutia BioEnvelope, the M1-driven foreign body response may result in a fibrotic capsule, which is associated with long-term complications. Conversely, the ECM promotes an M2-driven regenerative response, resulting in a systemically connected healthy tissue pocket long term.
Elutia is the regenerative medicine company that provides physicians with next-generation natural, patient-focused solutions.
Learn more:
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