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New Localized Pain Treatment System Available from B. Braun; LidoSite Topical System Reduces Needlestick Pain of Common Medical Procedures in Children, Adults.


BETHLEHEM, Pa. -- B. Braun, a leading healthcare products and services company and worldwide leader in regional anesthesia regional anesthesia
n.
Anesthesia characterized by the loss of sensation in a circumscribed region of the body, produced by the application of a regional anesthetic, usually by injection.
, announced today the availability of the LidoSite(TM) Topical System, a method to help reduce needlestick pain associated with procedures such as intravenous cannulation can·nu·la·tion or can·nu·li·za·tion
n.
Insertion of a cannula.



cannulation

introduction of a cannula into a tubelike organ or body cavity.
, venipuncture venipuncture /veni·punc·ture/ (ven?i-pungk´chur) surgical puncture of a vein.

ve·ni·punc·ture or ve·ne·punc·ture
n.
, or laser ablation of superficial skin lesions Skin Lesions Definition

A skin lesion is a superficial growth or patch of the skin that does not resemble the area surrounding it.
Description

Skin lesions can be grouped into two categories: primary and secondary.
 for patients age five and up. The LidoSite Topical System, comprised of the LidoSite Patch (Lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a  HCl/Epinephrine Topical Iontophoretic Patch) 10%/0.1% and the LidoSite Controller, provides pain reduction equivalent to a Lidocaine injection without the needlestick.

Unlike the topical anesthetic creams typically used in today's healthcare settings to address needlestick pain, the LidoSite System delivers numbing medication to the procedure site quickly and effectively after a 10 minute application. Topical anesthetic creams usually take up to an hour for full anesthetic benefit.

"Needlesticks for children can arouse more fear than major surgeries and other more invasive procedures," according to William T. Zempsky, MD, Associate Director, Pain Relief Program Connecticut Children's Medical Center. "The LidoSite Topical System offers these patients several advantages over other commercially available topical anesthetic systems. Namely, it provides topical anesthesia Topical Anesthesia Definition

Topical anesthesia is a condition of temporary numbness caused by applying a substance directly to a surface of the body. Loss of feeling occurs in the specific areas touched by the anesthetic substance.
 in just 10 minutes compared to topical creams requiring 30-60 minutes; and it is simple to use - anesthetic delivery starts with a single button push compared to older more cumbersome systems."

"A large, multi-center study recently showed that the LidoSite Topical System was well accepted by children and adults," Zempsky continues. "LidoSite proves that lidocaine iontophoresis iontophoresis /ion·to·pho·re·sis/ (i-on?to-fah-re´sis) the introduction of ions of soluble salts into the body by means of electric current.iontophoret´ic

i·on·to·pho·re·sis
n.
 provides not only faster, but superior depth of anesthesia compared to commonly used prescription topical creams."

"Many hospitalized children fear a needle more so than other medical procedures," said Christopher DiBiase, Product Director, Pain Control, B. Braun Medical Inc. "LidoSite provides the necessary anesthesia while minimizing the pain and anxiety associated with venipuncture."

The LidoSite Topical System enables medical practitioners to easily comply with American Pain Society (APS) and the American Academy of Pediatrics The American Academy of Pediatrics ("AAP") is an organization of pediatricians, physicians trained to deal with the medical care of infants, children, and adolescents. Its motto is: "Dedicated to the Health of All Children.  (AAP AAP - Association of American Publishers ) guidelines for adequately addressing acute - or short-lived - pain. These guidelines, which apply to the treatment of children and adults, call for healthcare practitioners to eliminate or reduce pain caused by medical treatments whenever possible. In fact, the APS and AAP agree that acute pain experienced with medical procedures can, in most cases, be substantially reduced and even prevented.

Results from many medical facilities' Press-Gainey Patient Satisfaction surveys show that discomfort associated with obtaining IV access is an aspect of patient care that requires improvement.(1) To improve patient care quality, and maintain Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations,
n.pr the United States body that accredits healthcare organizations.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
n.
 (JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there ) accreditation, some facilities have identified reducing pain associated with IV access as a quality improvement goal. The LidoSite Topical System presents them with an option for meeting this goal without the drawbacks inherent in existing systems.

The LidoSite Topical System consists of a single-use, pre-filled LidoSite Patch, filled with Lidocaine HCl 10% and Epinephrine 0.1%, and the LidoSite Controller, an easy-to-use pre-programmed device that activates the patch. Through a proven process called iontophoresis, the Patch is activated by a mild current from the Controller to accelerate delivery of Lidocaine - the anesthetic medication - to the injection site. Epinephrine contained in the LidoSite Patch helps focus the anesthetic effect directly under the Patch and extends the duration of the effect for an hour.

The LidoSite System was developed by Vyteris, Inc., Fair Lawn, NJ and received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 clearance in 2004. B. Braun is the exclusive marketing partner of Vyteris for the LidoSite Topical System.

The LidoSite(TM)Topical System is indicated for use on normal intact skin to provide local analgesia for superficial dermatological procedures such as venipuncture, IV cannulation and laser ablation of superficial skin lesions. The LidoSite System is contraindicated in patients with a known history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to local anesthetics of the amide type, sulfites or to any other component of the product. It is also contraindicated for use in patients with electrically-sensitive devices (e.g., pacemakers) and should not be used on areas of the body supplied by end arteries or having otherwise compromised blood supply. Patients over 65 years of age may have greater sensitivity to the LidoSite Patch than younger patients. Iontophoresis with the LidoSite Patch may cause local transient skin irritation such as blanching
For the term used in coinage, see Blanching (coinage).
Blanching is a cooking term that describes a process of food preparation wherein the food substance, usually a vegetable or fruit, is plunged into boiling water, removed after a brief, timed interval
 or erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns.  in the dermis dermis: see skin.  under the patch. The potential exists for a small child to suffer serious adverse effects from chewing or ingesting a new or used LidoSite Patch. Children should be closely observed when treated with the LidoSite System, and LidoSite Patches should be stored and disposed of in the proper manner. Safety and effectiveness in pediatric patients below age five have not yet been established.

Please refer to the full Prescribing Information, including the detailed instructions for use, before using the LidoSite Topical System.

About B. Braun

Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance both patient and health-professional safety. Its 30,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness, and environmental responsibility.

Through its "Sharing Expertise(TM)" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. For more information about B. Braun or its safety healthcare products, call 800-854-6851, or visit B. Braun at www.bbraunusa.com.

About Vyteris

Vyteris, Inc., a wholly-owned subsidiary of Treasure Mountain Holdings, Inc., (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 BB: TMHI) is a pharmaceutical company that develops and manufactures pharmaceutical products based on its advanced drug delivery technology. The Company's state of the art, proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This technology allows precise dosing thus providing physicians and patients with unparalleled control in the rate, dosage, and pattern of delivery. In addition to the LidoSite System, Vyteris is currently developing products in a number of areas including women's health and Parkinson's disease. For more information, visit www.vyteris.com.
(1) Morrison, R., et al.: "Pain and Discomfort Associated with Common
Hospital Procedures and Experiences", Journal of Pain and Symptom
Management. 15(2): 91-101, 1998.
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Date:Feb 7, 2005
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