Aziyo Completes Enrollment in Prospective Post Market Study of CanGaroo ECM Envelope

Aziyo Biologics Inc., a fully integrated regenerative medicine company, has completrf patient enrollment in SECURE, a prospective post market study of 1,000 patients treated with CanGaroo ECM Envelope in conjunction with cardiac implantable electronic device (CIED) placement.
 
The CanGaroo ECM Envelope is intended to securely hold a CIED to create a stable environment following surgery. Cardiac rhythm management devices such as permanent pacemakers and cardioverter defibrillators may be used with the CanGaroo ECM Envelope. The prospective SECURE study is evaluating the CanGaroo ECM Envelope in 1,000 patients enrolled at 39 U.S. centers. The study includes patients that received the CanGaroo ECM Envelope during initial implantation or replacement of CIEDs. Patients will be followed to determine the incidence of device-related adverse events and infection following surgery utilizing CanGaroo.
 
“Better understanding of the benefits of a product like CanGaroo is critical to improving patient outcomes,” said Sidarth A. Shah, M.D., cardiologist at North Carolina Heart and Vascular. “Incidence of infection in implantable electronic devices continues to increase, presenting significant challenges for both patients and treating physicians. These challenging complications not only result in high patient morbidity and mortality, but have significant financial impacts as well.”
 
Preliminary study results indicate no device-related adverse events and a 0.6 percent infection rate with the use of CanGaroo ECM Envelope. Infection rates following CIED procedures have been rising and range from 2 percent to 4 percent depending on the risk factors present.
 
“We look forward to continuing research with CanGaroo to demonstrate the unique benefits of our biologic ECM,” said Lode Debrabandere, Ph.D., president and CEO of Aziyo Biologics Inc. “We are committed to differentiating our products with substantial clinical and pharmacoeconomic data, and with the help of dedicated surgeons and patients, we are making significant progress towards that goal with CanGaroo.”
 
The CanGaroo ECM 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, the 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. To date, CanGaroo has been implanted in more than 10,000 procedures. CanGaroo ECM Envelope is a 510(k) U.S. Fdood and Drug Administration-cleared medical device.

Porcine SIS is a decellularized matrix that serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM is gradually replaced as the patient’s own cells restore the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. Since 1999, an estimated two million patients worldwide have received SIS ECM implants.
 
Aziyo Biologics is a fully integrated regenerative medicine company formed by HighCape Partners, Deerfield Management Co., and KeraLink International. Aziyo combines a portfolio of cardiac and orthopedic products with deep commercial expertise to build value. The commercial and pipeline products include medical devices and human tissue-based products for surgical implantation. The company is based in Silver Spring, Md.