Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces that REGRANEX (becaplermin) Gel, 0.01%, OASIS Wound Matrix, and OASIS Ultra Tri-Layer Matrix have been granted the American Podiatric Medical Association (APMA) Seal of Approval.
“We are honored to receive this prestigious designation from APMA, demonstrating the benefits of these products in treating diabetic foot ulcers,” said Francois Fournier, President, U.S. Commercial, Advanced Wound Management. “Our goal at Smith & Nephew is to provide advanced therapies which help our customers treat hard-to-heal wounds and chronic wounds. The APMA Seal of Approval reinforces our position supporting the medical community in promoting good foot health.”
APMA strives to provide reliable information about the quality and effectiveness of available products and therapies to clinicians and patients. For over 35 years, the APMA Seal of Acceptance and Seal of Approval have been granted to products found to promote positive foot health. To earn the Seal of Approval, a product is carefully reviewed by a group of APMA podiatrists, who conduct a detailed scientific evaluation. After extensive review, the Seal is granted to products that show evidence of safety and effectiveness. Not every product reviewed by APMA will be granted a Seal.
About the American Podiatric Medical Association
The American Podiatric Medical Association (APMA) is the nation's leading professional organization for today’s podiatrists. Doctors of Podiatric Medicine (DPMs) are qualified by their education, training, and experience to diagnose and treat conditions affecting the foot, ankle, and structures of the leg. APMA has 53 state component locations across the United States and its territories, with a membership of more than 12,000 podiatrists. All practicing APMA members are licensed by the state in which they practice podiatric medicine.
OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix
OASIS Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled, undermined wounds, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, and surgical wounds (donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence). This device is not indicated for use in third-degree burns. This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.
REGRANEX Gel
REGRANEX (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application and in patients with known hypersensitivity to any component of the product (e.g., parabens).
IMPORTANT SAFTEY INFORMATION
WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY
An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.
Enquiries
Christie Teller 817.905.7158
Smith & Nephew 817.916.2242
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.
Forward-looking Statements
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® OASIS is a registered trademark of Cook Biotech, Inc.