SILVER SPRING, Md.--(BUSINESS WIRE)--Aziyo Biologics, Inc. a fully integrated regenerative medicine company, today announced completion of 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 US 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 & 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 presented at the EHRA EUROSPACE - CARDIOSTIM 2017 Conference in June reported no device-related adverse events and a 0.6% infection rate with the use of CanGaroo ECM Envelope. Infection rates following CIED procedures have been rising and range from 2% to 4% 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 Chief Executive Officer 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.”
About CanGaroo® ECM® Envelope
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) FDA cleared medical device.
About Porcine SIS
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.
About Aziyo Biologics, Inc.
Aziyo Biologics, Inc. is a fully integrated regenerative medicine company formed by HighCape Partners, Deerfield Management Co. and KeraLink International. Aziyo is transforming regenerative medicine by combining an innovative portfolio of cardiac and orthopedic products with deep commercial expertise to build value. The commercial and pipeline products include 510(k) FDA cleared medical devices and human tissue-based products for surgical implantation. Aziyo’s vision is to improve healthcare through regenerative medicine solutions supported by strong scientific, clinical and cost-benefit data.