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Research Indicates 86 Percent Success Rate for Anal Fistula Repair Utilizing Surgisis Biodesign(TM).


First European Studies European studies is a field of study offered by many academic colleges and universities that focuses on the current development of European integration. It basically consists of a combination of several subjects, including European history, European law, economics and sociology.  on Fistula fistula (fĭs`chlə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin.  Repair with Cook Medical's Breakthrough Anal Fistula anal fistula
n.
A fistula opening at or near the anus, usually into the rectum above the internal sphincter.
 Plug Indicate High Healing Rate and Reduced Patient Trauma

BLOOMINGTON, Ind. -- Cook Medical today released the first ever European research findings on anal fistula repair in conjunction with the Cook Medical symposium at the European Society for Coloproctology (ESCP ESCP Ecole Supérieure de Commerce de Paris
ESCP European Society of Clinical Pharmacy
ESCP European Society of Coloproctology (Edinburgh, UK)
ESCP Erosion and Sediment Control Plan
ESCP European Small Claims Procedure
) event in Malta. Leading European surgeons have spent the last 12 months investigating the efficacy and effectiveness of unique Surgisis[R] Biodesign[TM] Anal Fistula Plug (AFP (1) (AppleTalk Filing Protocol) The file sharing protocol used in an AppleTalk network. In order for non-Apple networks to access data in an AppleShare server, their protocols must translate into the AFP language. See file sharing protocol. ).

A cone-shaped medical device that has been specifically designed to allow a surgeon to easily place it into a fistula tract, the Surgisis Biodesign AFP is the world's first medical device designed to permanently close painful, debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 anal fistulas. The research findings from six European studies highlight the benefits of eliminating an invasive procedure associated with complications and poor outcomes and the significant short and long-term difference to patient lifestyle and wellbeing.

Andy Cron, vice president of the Surgery strategic business unit of Cook Medical, comments: "More than 100,000 anal fistula surgeries are currently performed each year across the United States. The condition is extremely painful and can seriously impact a patient's life. We launched the Surgisis Biodesign AFP last year to help improve the plight of these patients and help the surgeons treating them. The results of these studies show just how successful the product is - with an 86% healing rate. It's all about increasing the options for patients with chronic anal fistulas."

Study highlights include:

* 86% of anal fistulas healed after repair with the Surgisis Biodesign AFP. (Leonardo Lenisa, San Pio X Hospital, Milan, Italy)

* No major complications observed in any patients and no sepsis in recurrent patients. (Leonardo Lenisa, San Pio X Hospital, Milan, Italy)

* Continence continence /con·ti·nence/ (kon´tin-ens) the ability to control natural impulses.con´tinent

con·ti·nence
n.
1. Self-restraint; moderation.

2.
 unaffected by surgery - in contrast with fistulotomy, which can result in faecal fae·cal  
adj. Chiefly British
Variant of fecal.

Adj. 1. faecal - of or relating to feces; "fecal matter"
fecal
 incontinence, with minimal tissue manipulation. (Leonardo Lenisa, San Pio X Hospital, Milan, Italy)

* Patient trauma far less using Surgisis Biodesign AFP than with traditional repair methods of advancement flap advancement flap
n.
See sliding flap.
. (Thilo Schwandner, University of Giessen The University of Gießen (German: Universität Gießen) is officially called Justus Liebig-Universität Gießen after its most famous member, Justus von Liebig, the founder of modern agricultural chemistry and inventor of artificial fertiliser. , Germany).

"We presented these results to surgeons across Europe at the ESCP event in Malta, showing them this simple and effective treatment for what is a complex, notoriously difficult surgical problem", concludes Cron.

What is Surgisis Biodesign AFP?

Surgisis Biodesign AFP, sold by Cook Surgery, is a cone-shaped medical device that has been specifically designed to allow a surgeon to easily place it into a fistula tract. Once in place, Surgisis Biodesign AFP serves as a bio-scaffold, signalling new, fully vascularised tissue to grow over and close the fistula.

About Anal Fistulas

A fistula is an abnormal channel that develops between body organs. The most common fistulas occur from the intestine to an opening in the skin. The presence of a fistula can be painful and seriously impact a patient's quality of life. Unfortunately, current treatments involving either an extensive surgical procedure or use of fibrin glue fibrin glue Fibrin sealant Surgery A liquid commercial product composed of purified fibrinogen and thrombin used to seal operative wounds, by partially re-enacting the final stage of the coagulation cascade, in which fibrinogen is converted to fibrin in the  do not always yield satisfactory results, leaving the patient with a chronic, debilitating problem.

About ESCP

The annual meeting of the European Society of Coloproctology was held in Malta from September 26 - 29, 2007. For further information, please visit http://www.escp.eu.com/malta/article.php?id=141 .

About Cook Medical

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotechnology to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry.

For more information, visit www.cookmedical.com
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Publication:Business Wire
Date:Oct 8, 2007
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