Aziyo Biologics Announces Publication of a CanGaroo® Case Study Demonstrating Bioenvelope Benefits for Reoperative Procedures

Case provides first histologic evidence that CanGaroo can catalyze development of new healthy tissue layer within an existing cardiac implantable electronic device (CIED) pocket

SILVER SPRING, Md., Aug. 30, 2023— Aziyo Biologics, Inc., a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced the publication of a case report highlighting results that demonstrate the potential benefits of using a biological device envelope during reoperative procedures for CIEDs.

The report, titled “Rehabilitation of an Existing Device Implant Pocket Using a Biologic Extracellular Matrix Envelope,” was published in the peer-reviewed journal Heart Rhythm Case Reports. The results suggest a biological envelope may mitigate the risks and procedural difficulty associated with reusing fibrotic implant pockets, which could facilitate future reoperations and decrease post-operative complications. This case study builds upon interim results from the HEAL Study indicating that CanGaroo can significantly reduce fibrous lead entrapment and decrease procedural difficulty when used during initial device implantation. CanGaroo is the only biological envelope available for use with implantable electronic devices.

“This case study builds upon the interim HEAL Study data presented earlier this year at Heart Rhythm 2023,” said Dr. Michelle LeRoux Williams, Chief Scientific Officer of Aziyo. “These results provide an opportunity to evaluate the use of CanGaroo within a reoperative pocket. CanGaroo has proven to show superior tissue remodeling properties and can provide a solution for patients and their physicians seeking to avoid complications associated with reoperations.”

Case Study Overview

The patient was a 73-year-old man with normal immune and kidney function who underwent a replacement procedure for an Implantable Cardioverter Defibrillator (ICD). At the time of the reoperation, the existing pocket was highly fibrotic. The ICD was surgically removed and leads freed, but most of the fibrotic tissue remained. To rehabilitate the fibrotic pocket, the new ICD was placed into a CanGaroo envelope and implanted.

Five months later, an additional procedure was performed to resolve a lead complication. At that time, the entire pocket was observed to be lined with a soft vascularized capsule, and now the leads were free of fibrosis and calcification.

A biopsy of the pocket showed a new pocket wall containing thin, cellularized and vascularized tissue, consistent with a fully remodeled envelope. The implanted CanGaroo was fully resorbed.

The patient had an uneventful recovery and remains stable at three years post-operation. The findings in this case study are consistent with previously reported data published in Circulation demonstrating that CanGaroo prevents foreign body reactions within the host, reducing hypovascular fibrous capsule development.

About Aziyo Biologics

Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.