30 August 2017 - - Silver Spring, Maryland-based regenerative medicine company Aziyo Biologics, Inc. has completed 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 company said.
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.
The CanGaroo ECM Envelope is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix 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.
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.
Aziyo Biologics is a fully integrated regenerative medicine company formed by HighCape Partners, Deerfield Management Co. and KeraLink International.
The company combines an innovative portfolio of cardiac and orthopedic products with deep commercial expertise to build value. Its commercial and pipeline products include 510(k) FDA cleared medical devices and human tissue-based products for surgical implantation.