The prospective, multi-center study anticipates enrolling up to 500 participants who are undergoing implementation of a CIED with either a CanGaroo Envelope (approximately 330 patients) or no envelope (approximately 170 participants).
“The initiation of the CanGaroo De Novo Study marks an important milestone for Aziyo,” said Ron Lloyd, president and CEO of Aziyo. “While we are confident that all CIED patients have the potential to benefit from our CanGaroo Envelope based on remodeling into a healthy pocket of systemically vascularized tissue and potentially reducing the risk of fibrotic capsule formation, we believe the benefit may be even more pronounced in patients receiving their first CIED implant. For this reason, this study focuses on these de novo implant patients.”
The study is designed to provide insights into the profiles of patients selected for CanGaroo implantation, as well as the clinical decision making by physicians. Clinical outcomes of up to three months will be collected from all enrolled participants. The study also is anticipated to include a group of patients less than or equal to 65 years of age who will be followed for up to five years after treatment to provide insights into the pattern of longer-term outcomes and additional benefits.
“The currently enrolling HEAL Study is focused on evaluating the tissue and biologic changes in the device implant pockets, including the CanGaroo Envelope, associated with CIED envelope use at the time of device change out or revision. This new study is intended to demonstrate the value of this biologic impact in de novo implant patients followed long-term, and we believe it will be complementary to the HEAL study,” added Dr. Jerome Riebman, chief medical officer of Aziyo.
The enrollment for this study is expected to close within 18 months, and standard follow-up will close at 21 months with the long-term subgroup followed for up to five years. The endpoint of this study is a cohort comparison of clinically significant factors, such as physical, medical and demographic characteristics, medical history, risk factors related to post-procedure events, and associations with outcomes and events.
The CanGaroo Envelope is a small intestine submucosa extracellular matrix designed to mitigate complications deriving from implantable electronic devices and the shortcomings of synthetic envelopes. Once implanted, it creates a hospitable environment for the surrounding cells to migrate into the bio scaffold and start matrix turnover. The natural envelope is remodeled into a healthy pocket of systemically vascularized tissue, potentially reducing the risk of fibrotic capsule formation, migration and erosion of the implantable device through the skin, and complications associated with Twiddler’s syndrome. The CanGaroo Envelope may also facilitate the process of implantation and of device removal during its replacement, as well as enhance patient comfort.