Healthcare Industry News:   diabetic foot ulcer 

Devices Wound Care Regulatory

 News Release - January 18, 2013

Integra LifeSciences Announces Launch of Integra(R) Flowable Wound Matrix in Europe for Diabetic Foot and Leg Ulcers

Device Awarded Most Innovative New Product by French Society of Reconstructive & Esthetic Plastic Surgery

PLAINSBORO, N.J., Jan. 18, 2013 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (IART) today announced that it has received European CE Mark Certification for its Integra(R) Flowable Wound Matrix, an advanced device approved in the European Union for filling deep soft tissue or tunneling wounds, including diabetic foot and leg ulcers.

The Societe Francaise de Chirurgie Plastique Reconstructrice et Esthetique (SOF.CPRE) (French Society of Reconstructive and Esthetic Plastic Surgery), one of Europe's pre-eminent medical associations, has also awarded Integra's Flowable Wound Matrix 1st place in its innovation contest. Each year, over 1,000 surgeons attend the annual meeting and are asked to vote on the most innovative new product, based on its performance. This year, the majority of the voters selected Integra's Flowable Wound Matrix.

"We are extremely honored that Integra's Flowable Wound Matrix has been recognized by surgeons as one of the most innovative new products available for the management of chronic wounds," said Debbie Leonetti, Integra's Corporate Vice President, President - International. "Tens of thousands of patients in Europe suffer from chronic foot and leg ulcers that progress to deep or tunneling wounds, and they face serious risk of amputation. Integra's Flowable Wound Matrix now offers surgeons, and patients, a new option for managing these hard-to-access wounds."

Integra(R) Flowable Wound Matrix is the flowable version of Integra's wound matrix and uses the company's proven collagen technology, whose effectiveness has been widely demonstrated over the past 20 years in a variety of indications, including life-threatening burns and scar revisions. The product's release in Europe is backed by five years of use in the United States and Latin America, where it is already used to meet the specific clinical requirements for managing wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds.

"The product's reputation has spread well beyond American borders, and many European wound specialists are waiting for it," said Marie-Ange Passemard, EMEA Marketing and Sales Director, Integra Skin and Wound. "Thanks to its release on the European market, we will be able to meet demand from centers specialized in treating chronic wounds, which are faced with a steep increase in the number of diabetes-related pathologies. This is good news for patients, who will have an alternative to the usual treatment for their wounds."

The incidence of diabetes continues to accelerate, affecting approximately 55 million people in the European Union, of which an estimated 3 million will develop a foot ulcer. Between 15% and 20% of these ulcers eventually result in an amputation. However, many of these amputations could be prevented with proper intervention.

Integra(R) Flowable Wound Matrix is sold by Integra's European Skin and Wound sales organization.

Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. For more information, please visit

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2011 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source: Integra LifeSciences

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