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Independent Studies on FzioMed's Anti-Adhesion Gel Presented at Spine Meetings.


SAN LUIS OBISPO San Luis Obispo (săn l`ĭs ōbĭs`pō), city (1990 pop. 41,958), seat of San Luis Obispo co., S Calif., near San Luis Obispo Bay; inc. 1856. , Calif. -- FzioMed, Inc. announced today reports of positive clinical experiences by European surgeons using the company's adhesion barrier gel to prevent postoperative adhesions from forming after back surgery. Presentations are being made at annual meetings of the Congress of Neurological Surgeons (CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
) in Chicago this week and at the upcoming European Spine Society's Annual Meeting (EuroSpine) to be held October 25-28 in Istanbul, Turkey.

FzioMed's adhesion barrier is an injectable, absorbable gel, in a 3mL syringe, for use in reducing the incidence, extent and severity of postsurgical adhesions following lumbar spine Lumbar spine
The segment of the human spine above the pelvis that is involved in low back pain. There are five vertebrae, or bones, in the lumbar spine.

Mentioned in: Low Back Pain
 surgery. Postsurgical adhesions are abnormal bands of scar tissue that can form between tissues following surgery and cause postoperative complications such as recurrent back pain and weakness.

The gel is placed in the epidural space during laminectomy laminectomy /lam·i·nec·to·my/ (lam?i-nek´tah-me) excision of the posterior arch of a vertebra.

lam·i·nec·to·my
n.
Excision of a vertebral lamina. Also called rachiotomy.
, laminotomy, and discectomy disc·ec·to·my
n.
The partial or complete excision of an intervertebral disk. Also called discotomy.
 procedures to separate tissues and act as a temporary, protective barrier against adhesion formation. The product is marketed outside the United States as MediShield[TM] Anti-Adhesion Gel and as Oxiplex([R])/SP Adhesion Barrier Gel. FzioMed is completing a pivotal clinical trial of Oxiplex/SP in the U.S.

The presentation, "Use of a Novel Gel-Formulated Anti-Adhesion Barrier for Prevention of Fibrotic Adhesions in Lumbar Micro-discectomy Procedures," at both CNS and EuroSpine, describes a controlled study comparing a gel-treated group of patients to a control group of patients who received no gel. No or negligible scar tissue was evidenced in 73.5% of patients treated with gel compared to significant scarring noted in 79.9% of controls. There were no complications or allergic reactions related to the gel.

A presentation at CNS, titled "Clinical Experience with the Use of MediShield Gel for the Prevention of Peridural Fibrosis," describes a controlled study comparing a gel-treated group of patients to a control group of patients who received no gel, in which the gel provided a significant protective effect against recurrent sciatica sciatica (sīăt`ĭkə), severe pain in the leg along the sciatic nerve and its branches. It may be caused by injury or pressure to the base of the nerve in the lower back, or by metabolic, toxic, or infectious disease.  in patients with and without recurrent disc herniation herniation /her·ni·a·tion/ (her?ne-a´shun) abnormal protrusion of an organ or other body structure through a defect or natural opening in a covering, membrane, muscle, or bone. . There were no complications related to the gel.

About FzioMed

FzioMed is a medical company developing and commercializing absorbable, surgical biomaterials based on the company's patented Oxiplex science. Oxiplex is an innovative medical polymer technology with uses in a variety of specialties including orthopedics, spine, gynecology, general surgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery currently marketed outside of the United States, Oxiplex/AP adhesion barrier for gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology.  and general surgery, and Laresse[TM] cosmetic dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 filler. FzioMed products are for investigational use only in the U.S. Go to www.fziomed.com.

FzioMed[R], Oxiplex[R] and Laresse[TM] are trademarks of FzioMed, Inc., and MediShield[TM] is a trademark of Medtronic Sofamor Danek.
COPYRIGHT 2006 Business Wire
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 13, 2006
Words:444
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