Aziyo Biologics has recruited the first patient in the HEAL study to assess the biologic and clinical effects of device envelopes.
The trial will study the device envelops that are placed around cardiovascular implantable electronic devices (CIEDs) at the time of implantation surgery.
The national multi-centre study will assess up to 100 patients who earlier underwent implantation of CIEDs with either an Aziyo CanGaroo envelope, Medtronic’s Tyrx or envelope.
HEAL will evaluate patients who have had their implants for at least a year and are returning for a CIED change-out or revision procedure.
Aziyo’s study will focus on finding characteristics of soft tissue healing surrounding the CIED implant.
It will done using tissue biopsies gathered at the time of the change-out/revision procedure for patients treated with or without an envelope at the time of device implantation.
Aziyo president and CEO Ron Lloyd said: “We are pleased to see the commencement of this important study, as we believe it has the potential to validate the significant contribution that a biological envelope can provide to patients receiving a CIED.
“In addition, we believe this study has the potential to provide further insight into the ability of our CanGaroo Envelope to create a healthy, vascularized pocket to reduce complications that can arise with an implantable CIED, such as fibrotic capsule formation, device migration or erosion.”
The CanGaroo Envelope is a small intestine submucosa extracellular matrix designed to reduce complications originating from implantable electronic devices and the shortcomings of synthetic envelopes.
Upon implantation, the envelope builds a hospitable environment for the surrounding cells to migrate into the bio scaffold and begin matrix turnover.
Aziyo stated that the natural envelope is remodeled into a healthy pocket of systemically vascularised tissue to minimise the risk of fibrotic capsule formation, migration and erosion of the implantable device through the skin, and complications associated with Twiddler’s syndrome.
In addition, the CanGaroo Envelope could also enable the process of implantation and of device removal during its replacement.
Recently, Aziyo announced product design completion for CanGaroo with antibiotics to reduce the potential risk of post-operative infections.
