APMA News - September 2012 - (Page 52)

Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling. Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure. Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf. DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers. Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice. How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8 References: 1. Veves A, Falanga V, Armstrong DG, Sabolinski ML; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295. 2. Data on file, Organogenesis Inc. 3. Apligraf® [package insert]. Canton, MA: Organogenesis Inc; 2010. Please see complete prescribing information at www.Apligraf.com © 2011 Organogenesis Inc. All rights reserved. Printed in U.S.A. 01/11 Apligraf is a registered trademark of Novartis. Need Help Starting a Podiatric Residency Program? “Podiatric medicine needs to grow 16 percent from now until 2014 in order to keep pace with an aging and diabetes prolific U.S. population.” —Bureau of Labor and Statistics Are you successful in practice? Give back by starting a residency program! If you enjoyed your residency experience, help us provide every student with the best education. The American Podiatric Medical Association (APMA), representing the country’s leading foot and ankle physicians and surgeons, is offering hospitals assistance in establishing and growing existing podiatric residency programs. Podiatric residency programs are currently not capped for graduate medical education (GME) reimbursement. Call 1-800-372-0775 for assistance in generating or expanding podiatric medical and surgical residency programs in your hospital. CPME Council on Podiatric Medical Education 52 APMA News September 2012 http://www.Apligraf.com http://www.Apligraf.com

Table of Contents for the Digital Edition of APMA News - September 2012

APMA News - September 2012
President’s Message
Contents
US Surgeon General Addresses APMA at The National
2012 is a Milestone Year for APMA, and for Other Institutions as Well
APMA Member and Daughter Help Disabled Find their Freedom
Dr. Caporusso Promotes Podiatric Medicine on Capitol Hill
Use eAdvocacy to Reach Your Elected Leaders Today!
APMA by the Decade: 1982–1991
2012 Podiatric Practice Survey: Net Income Statistics
Reimbursement
Federal Advocacy Forum
List of Cosponsors to the Equity and Access for Podiatric Physicians Under Medicaid Act
APMAPAC Chair Report
IT Consultant
Website Wisdom
Technofile
Bylaws Propositions Due
Small Business 101
APMA All Stars
Resolutions Deadlines
In Short
Worthy of Note
CPME Invitation for Comments
Affiliates Corner
List of Affiliated Organizations
Insurance Advisor
New Members
Death Notices
APMAPAC Update
Annual Scientific Meeting Sponsors
Development Update
Classified Advertising
Dates to Remember
Advertising Index
10 Questions
Your APMA

APMA News - September 2012