APMA News - September 2013 - (Page 42)

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 Please see complete prescribing information at www.Apligraf.com © 2013 Organogenesis Inc. OI-A1112 All rights reserved. Printed in U.S.A. 4/13 Apligraf is a registered trademark of Novartis. Bylaws Propositions Due Submission of Proposed Modiﬁcations to the Bylaws, Code of Ethics, and Administrative Procedures APMA Bylaws propositions, including the Code of Ethics, are due to Glenn B. Gastwirth, DPM, APMA executive director, by October 1. The deadline to submit any proposed modifications to the APMA Administrative Procedures is January 30, 2014. Such amendments should be submitted in the form of a proposition following the same process used to propose a modification to the APMA Bylaws. Submissions can be mailed to the attention of Dr. Gastwirth at the American Podiatric Medical Association, 9312 Old Georgetown Road, Bethesda, MD, 20814 or e-mailed to Dr. Gastwirth at gbgastwirth@apma.org. APMA’s Bylaws and Procedures Committee will review the submissions and present them to the regular meeting of the House of Delegates, March 16–17, 2014, in Washington, DC. Please contact Teena Vaughn, executive assistant, with any questions at tdvaughn@ apma.org. 42 APMA News September 2013 Looking for patient-education materials for your website? Visit APMA.org/ Learn http://www.Apligraf.com http://www.Apligraf.com http://www.APMA.org/Learn

Table of Contents for the Digital Edition of APMA News - September 2013

APMA News - September 2013
President’s Message
Contents
What Happens in Vegas: The 2013 Annual Scientific Meeting
Annual Scientific Meeting Sponsors
Humanitarian Surgical Missions: A Different Kind of Residency Training
Collaboration is Key at Limb Salvage Clinic
Center for Professional Advocacy Reviews Recent California Medicaid Lawsuit
Oregon Podiatrists Achieve Physician Status
Letters to the Editor: Solving Our Residency Crisis; Remembering Our Heroes
Resolutions Submission Deadlines
Reimbursement
ICD-10: How to Code for Painful Hammer Toes
Federal Advocacy Forum
Cosponsors to the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians Act
APMAPAC Chair Report
Coverage Corner
Bylaws Propositions Due
IT Consultant
Website Wisdom
On the Road with APMA
Small Business 101
CPME Update
In Short
Worthy of Note
Affiliates Corner
New Members
Death Notices
APMAPAC Update
Development Update
Classified Advertising
Dates to Remember
Advertising Index
10 Questions
Your APMA

APMA News - September 2013