Published 06 November 2017
Aziyo Biologics has launched new CanGaroo bio envelope specifically for use with subcutaneous implantable cardioverter-defibrillators (S-ICDs).
This is the only cardiac implantable electronic device (CIED) envelope available for use with S-ICDs.
CanGaroo is a natural extracellular matrix (ECM) scaffold that is intended to securely hold CIEDs to create a stable environment following implantation.
Studies have demonstrated that use of CanGaroo when implanting CIEDs reduces the risk of device migration and erosion and may facilitate device removal when future exchange or revision is required.
The larger size and unique design of this new envelope expands the CanGaroo product line from four to five sizes to allow for use in securing larger subcutaneous devices.
“Creation of a natural regenerative implantation environment and preserving defibrillation threshold vectors with a stable shock impedance are challenging complications for patients undergoing implantation of S-ICDs,” said John N. Catanzaro, M.D. FACC, FESC, FHRS Electrophysiologist at the University of Florida Jacksonville.
“The availability of a bio envelope large enough to secure the S-ICD is of paramount importance for the potential to achieve effective defibrillation.”
“A number of different challenges are associated with the implantation of subcutaneous ICDs versus traditional transvenous ICDs due to device location and placement,” said Patrick Ferguson, Vice President of Sales at Aziyo Biologics. “Our bio envelope is specifically designed to complement the subcutaneous implant experience providing long-term pocket health and vector stabilization.”
The CanGaroo Bio Envelope is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS).
Once implanted, CanGaroo secures the CIED in place, and evidence shows that over time it remodels into a vascularized pocket that may facilitate CIED removal or revision. CanGaroo Bio Envelope is a 510(k) FDA cleared medical device.
Source: Company Press Release