Integra LifeSciences Holdings Corporation announced the first clinical implant of INTEGRA(R) Dermal Regeneration Template in Japan. The operation was performed by Dr. Hajime Matsumura of Tokyo Medical University Hospital. INTEGRA(R) Dermal Regeneration Template obtained Seizo Hanbai Shonin approval (Marketing Authorization License) from the Japanese Regulatory authorities in 2008 for the treatment of deep second- and third-degree burns (life-threatening burns). INTEGRA(R) Dermal Regeneration Template is distributed in Japan by Century Medical, Inc.
INTEGRA(R) Dermal Regeneration Template was the first regenerative product approved by the FDA for the treatment of life threatening burns and scar revisions. Since gaining the initial FDA approval in 1996, the INTEGRA(R) Template has been used successfully on over 100,000 patients, and is sold worldwide in over 40 countries.
"INTEGRA(R) Dermal Regeneration Template is an innovative product that provides surgeons with a viable or enhanced alternative to autograft and, more importantly, enables the human body to regenerate functional, flexible dermal tissue that adapts as the patient moves, grows and ages," commented Dr. Naoki Aikawa, Professor Emeritus of Keio University and the past President of the International Society for Burn Injuries, who worked as the chief investigator of the clinical trial of INTEGRA(R) Dermal Regeneration Template in Japan.
INTEGRA(R) Dermal Regeneration Template is an advanced bilayer skin replacement system, designed to provide immediate wound closure and permanent regeneration of the dermis. The inner layer is placed in direct contact with the excised wound and consists of a complex 3-dimensional porous matrix that acts as a scaffold for cell migration and allows for regeneration of the dermal layer of the patient's skin. The outer layer is a thin silicone film that protects the regenerative matrix and the wound from infection and controls both heat and moisture loss. Once the dermis has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft, providing the patient with their own flexible, living skin.
"The first use of INTEGRA(R) Dermal Regeneration Template in Japan marks a significant milestone," said Stuart Essig, Integra's President and CEO. "This is another step in our efforts to offer our product worldwide and give both physicians and patients a proven treatment option for life-threatening burns."
Century Medical, Inc. is one of the largest independent medical device distributors in Japan. With over 30 years experience marketing medical devices in Japan, Century Medical, Inc. has been a pioneering force, successfully introducing many new technologies to the Japanese healthcare community.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year. Our products are used primarily in orthopedics, neurosurgery and general surgery. Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world. For more information, visit www.Integra-LS.com
CONTACT: Integra LifeSciences Holdings Corporation
Gianna Sabella, Director of Corporate Communications