April 12, 2018 — Biotronik U.S. and Aziyo announced a strategic agreement allowing Biotronik to distribute Aziyo's CanGaroo extracellular matrix (ECM) cardiovascular implantable electronic device (CIED) envelopes in the United States. BioEnvelope will be available from Biotronik starting in April 2018.
BioEnvelope reduces scar formation and has been shown to mitigate the risk of device migration and erosion in in vivo studies.1 Its ECM material consists of a flexible bioscaffold that remodels in three to six months while encouraging the body to naturally regrow and restore functional, vascularized tissue. The newly remodeled tissue may enhance patient comfort and facilitate easier CIED removal for future device replacements.
Device dislodgement and pocket infection following implantation are serious complications that are associated with higher mortality and increased healthcare costs.2 Biotronik partners with hospitals and health systems to alleviate the cost burden of long-term care for CIED patients.
With BioEnvelope, physicians can choose how to best treat each individual patient with or without local antibiotic use. This extends the benefits of CIED envelopes to more patients and further customizes care.
"It's an exciting time to embrace the merging fields of regenerative medicine and cardiac rhythm management," said John N. Catanzaro, M.D., FESC, FACC, FHRS, SECURE study investigator, associate medical director and associate program director of electrophysiology in Jacksonville, Fla. "The natural ECM material benefits our patients by promoting a natural healing environment that produces a healthy, vascularized tissue pocket without inflammation, scarring or calcification."
BioEnvelope is indicated for use with the full spectrum of transvenous and subcutaneous CIEDs and has a three-year shelf life. It is also made in five sizes, eliminating the need to manually resize envelopes on a case-by-case basis.
For more information: www.biotronik.com
1. Data on file.
2. Polyzos K et al. EP Europace. 2015, 17(5).