Michael Barbella, Managing Editor07.21.23
Aziyo Biologics Inc. is touting positive clinical data for its CanGaroo Envelope.
Citing results from the national multi-center HEAL study, the company claims its CanGaroo Envelope performed better than Medtronic's Tyrx non-biologic envelope. HEAL evaluated patients who previously underwent implantation of a cardiac implantable electronic device (CIED) with either an Aziyo CanGaroo Envelope, Medtronic’s Tyrx non-biologic envelope, or no envelope, and are returning for a revision procedure at least four months after initial placement. The CanGaroo Envelope is made of an acellular biologic matrix that is designed to promote a natural healing response, resulting in a healthy, vascularized tissue capsule.
“The HEAL data further support the potential of biologic envelopes to enhance pocket healing during CIED implantation and simplify reoperative procedures,” said John N. Catanzaro, M.D., associate professor of Medicine with the University of Florida and the study's lead investigator. “This study demonstrates that biologic envelopes, such as CanGaroo, can improve patient care and decrease complications following device implantation.”
Aziyo Biologics is basing its results on data from 43 patients (CanGaroo, n=11, Tyrx, n=15, or no envelope, n=17) used with their initial CIED implantation. This interim analysis includes the evaluation of medical and clinical profiles, procedural notes and physician subjective scoring of the pocket, and histology.
Key findings from the interim analysis include:
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and patients. The company is based in Silver Spring, Md.
Citing results from the national multi-center HEAL study, the company claims its CanGaroo Envelope performed better than Medtronic's Tyrx non-biologic envelope. HEAL evaluated patients who previously underwent implantation of a cardiac implantable electronic device (CIED) with either an Aziyo CanGaroo Envelope, Medtronic’s Tyrx non-biologic envelope, or no envelope, and are returning for a revision procedure at least four months after initial placement. The CanGaroo Envelope is made of an acellular biologic matrix that is designed to promote a natural healing response, resulting in a healthy, vascularized tissue capsule.
“The HEAL data further support the potential of biologic envelopes to enhance pocket healing during CIED implantation and simplify reoperative procedures,” said John N. Catanzaro, M.D., associate professor of Medicine with the University of Florida and the study's lead investigator. “This study demonstrates that biologic envelopes, such as CanGaroo, can improve patient care and decrease complications following device implantation.”
Aziyo Biologics is basing its results on data from 43 patients (CanGaroo, n=11, Tyrx, n=15, or no envelope, n=17) used with their initial CIED implantation. This interim analysis includes the evaluation of medical and clinical profiles, procedural notes and physician subjective scoring of the pocket, and histology.
Key findings from the interim analysis include:
- Physicians scored CanGaroo reoperations as having 46% easier generator mobilization (p=.02), 41% easier lead mobilization (p=.01), and 43% less overall procedural difficulty (p=.04) compared to no envelope.
- Lead adhesion classification was scored as significantly less severe in the CanGaroo group compared to no envelope (p=.003).
- Significantly fewer capsulectomy procedures were required in the CanGaroo vs. Tyrx group (83% less, p=.04).
- Independent, blinded histologic evaluation of pocket biopsies showed 30% thinner capsules in CanGaroo implant pockets vs. no envelope (p=0.12) and 32% thinner capsules vs. Tyrx (p=.09).
- No significant group differences were observed in mean age, gender, race, or prior implant history.
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and patients. The company is based in Silver Spring, Md.