SHIRE -DERMAGRAFT now available in Canada for the treatment of Diabetic Foot Ulcers
ENP Newswire - 26 March 2013
Release date- 25032013 - Montreal (Quebec) - Shire Canada Inc. announced today that DERMAGRAFT (human fibroblast-derived dermal substitute) is now available in Canada for the treatment of diabetic foot ulcers (DFUs) greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.
Health Canada issued a licence for DERMAGRAFT as a class IV medical device designed to be externally applied onto DFUs.
'DERMAGRAFT constitutes a true, additional treatment option to help patients with diabetic foot ulcers,' said Dr. Gary Sibbald, MD, FRCPC, MACP, FAAD, M.Ed., MAPWCA, Professor of Medicine and Public Health at the University of Toronto. 'DERMAGRAFT can lead to significant improvement in wound closure for stalled healable wounds compared to conventional therapy alone.''
One of the most devastating complications of diabetes, DFUs constitute a serious health issue estimated to cost the Canadian healthcare system more than $150 million annually . In its first and only report to date, the Health Care Innovation Working Group, created by the Council of Federation, identified DFUs as a leading health challenge .
'We are excited to be bringing DERMAGRAFT to Canada, as we believe it plays an important role in the treatment of DFUs,' said Jeff Jonas, MD, President of Shire Regenerative Medicine, Inc, the division of Shire that markets DERMAGRAFT. 'This is an important first step for Shire as we continue to build a global business that provides regenerative medicine solutions for people around the world with life-altering conditions.'
'The Shire Canada team is pleased to be expanding into a new therapeutic area,' added Claude Perron, Vice President and General Manager, Shire Canada Inc. 'We hope that Canadian patients and healthcare professionals will benefit from having DERMAGRAFT available as a new therapeutic option to treat DFUs.'
DFUs are chronic sores that can develop on the feet of people with diabetes. Among Canadians living with diabetes, up to 15% will experience a DFU in their lifetime .
DERMAGRAFT is approved as a class IV medical device in Canada for the treatment of DFUs. DERMAGRAFT is manufactured from human fibroblast cells derived from donated newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells.
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