Oxiplex Information PDF

Oxiplex®: An Introduction:  An easy-to-use, safe gel that improves outcomes for spine surgery patients by reducing adhesions and related symptoms such as pain. Using Oxiplex takes only seconds, but can enhance a patient’s quality of life.  Oxiplex has been available since 2002 and h...

Oxiplex®: An Introduction:  An easy-to-use, safe gel that improves outcomes for spine surgery patients by reducing adhesions and related symptoms such as pain. Using Oxiplex takes only seconds, but can enhance a patient’s quality of life.  Oxiplex has been available since 2002 and has been studied extensively across the world. Spinal Adhesions  Definition: Adherence of dura and/or nerve roots to the surrounding structures  Commonly referred to as:  epidural fibrosis  peridural fibrosis  perineural fibrosis Adhesions After Spine Surgery Chemical irritants may cause pain, weakness & adhesions. 2. Failed Back Surgery Leg Pain Back Pain Weakness Numbness Tingling Burning Pro-inflammatory mediators, cytokines and fibroblasts migrate to site and may cause pain and adhesions. Re-Operations  Up to 40% Failed Back Surgery (FBSS)  ~20% require re-operation  Re-ops complicated by adhesions at original operative site  Re-ops can cause more adhesions RE-OPERATION Oxiplex® Adhesion Barrier for Spine Surgery  Clear gel in 3mL sterile syringe  Flexible applicator tip  Oxiplex Reorder # = FPC-09006 Oxiplex® Gel  The Leading Adhesion Barrier for Spine Surgery Worldwide  Over 600,000 units sold worldwide  Excellent Safety Profile  Effective Pain Reduction  Adhesion Reduction  Oxiplex® Gel Oxiplex acts as a mechanical barrier to 1. 2. pro-inflammatory mediators, cytokines and fibroblasts which may cause pain and adhesions. Following decompression, Oxiplex Gel applied to nerve root, Dural sac and annulus fibrosus to level of laminectomy. Gel Physical Characteristics  Biocompatible  Absorbable  Synthetic (no animal or bacterial components)  Viscous, tissue adherent  Gel does not swell  Clear / colorless (allows visualization of operative site)  Room temperature storage  2-year shelf life Storage and Handling o o  Store at room temperatures (2 C – 25 C) o o  Do not expose to elevated temperatures (26 C to 39 C) for more than 6 days o  Never expose to temperatures greater than 39 C Packaging  Sterile in thermoform tray:  One Syringe 3mL (luer lock)  Applicator (luer lock)  Also provided:  Instructions for Use  Patient tracking labels (4)  Composition of Oxiplex® Gel Safe, well-characterized components: Carboxymethylcellulose (CMC) Polysaccharide of Glucose Composed of 2 polymers (CMC + PEO) mixed together in a diluted aqueous solution, stabilized with calcium chloride & sodium chloride in sterile water for injection. Composition of Oxiplex® Gel  CMC = Carboxymethylcellulose:  Polysaccharide polymer of glucose  Water soluble  Viscous gel in solution  PEO = Polyethylene oxide:  Water soluble polymer  Reduces the deposition of fibrin Mode of Action  Oxiplex® is designed to coat surfaces exposed in spinal decompression surgery, to form a temporary “physical barrier” that isolates exposed nerve fibers and dura from surrounding tissues.  The presence of this physical barrier has been shown to reduce peridural fibrosis and limits the exposure of nerve tissue to irritants that may cause pain (cytokines-prostaglandins). Resorption Process & Rate  Resorption takes place by Hydrolysis and Macrophagic activity, occurring gradually, over a 28-30 days period: there is a gradual decomposition starting from molecules of H2O which disappear.  Hydrolysis (from Greek hydro- meaning "water", and lysis, meaning "separation") usually means the cleavage of chemical bonds by the addition of water. Where a carbohydrate is broken into its component sugar molecules by hydrolysis this is termed saccharification. Generally, hydrolysis or saccharification is a step in the degradation of a substance.  Thanks to its bio-compatible components, resorption causes NO inflammatory response! MRI Scan with Oxiplex® 10 Days Post-op Instructions for Use  Oxiplex® is intended for use as a mechanical barrier to adhesion formation.  Oxiplex® is intended to be placed around neural tissues following spine surgery to reduce adhesion formation and related symptoms such as pain. Instructions for Use - Preparation  Remove thermoform from carton  Exterior of carton & thermoform tray are not sterile  To maintain sterility, peel open thermoform tray and place syringe and applicator onto sterile field  Twist off syringe cap and secure applicator tip to syringe Gel Application  Gel applied intraoperatively, during lumbar laminectomy, laminotomy or discectomy  At end of surgery, after hemostasis is achieved & immediately prior to closing soft tissue incisions;  Apply gel liberally around exposed tissues, coating dura and exiting nerve root along all surfaces (dorsal, ventral, medial and lateral surfaces).  Apply gel to fill depth of surgical site to level of ventral surface of vertebral lamina.  Do not irrigate the site after application of Oxiplex.  Finalize procedure and close according to standard technique. Gel Application  Oxiplex® Application to Nerve Root 1 https://www.youtube.com/watch?v=f5Y6c1zJFvA  Oxiplex® Application to Nerve Root 2 https://www.youtube.com/watch?v=6qQ8HVdQASc  Oxiplex® Animation https://www.youtube.com/watch?v=Gw5EGibUvYE  The Evidence is Clear https://www.youtube.com/watch?v=52_NUEEuMzM&t=1s Clinical Performance  Excellent Safety Profile:  Market Experience 600,000 spine surgery patients treated worldwide No device-related adverse events  US IDE Study: No safety issues associated with Oxiplex No clinically significant abnormal lab or physical findings Fewer neurological complications in Oxiplex group No CSF leaks in Oxiplex patients Fewer reoperations in Oxiplex group (n=1) versus Controls (n=6)  10 Additional Studies All Demonstrate Safety & Efficacy Clinical Performance  Excellent Safety Profile:  Non-Clinical Testing Extensive preclinical testing Oxiplex reduces epidural fibrosis without affecting dural healing Oxiplex does not inhibit normal bone healing U.S. Pivotal Clinical Trial Results  U.S. prospective, randomized, blinded, multi-centre trial  Objective: Evaluate safety & effectiveness of Oxiplex Gel for the reduction of pain & symptoms following lumbar disc surgery  352 patients, 29 sites  Patients randomized to receive surgery plus Oxiplex or surgery alone (Control group)  Patients assessed at Baseline and at 1, 3, and 6 months post-op  Oxiplex® Gel Study Group Paul Arnold, MD Michael Janssen, DO Alfred Rhyne, MD University of Kansas Medical Center Center for Spinal Disorders OrthoCarolina Spine Center Anthony Asher, MD Donald Johnson, MD Srinath Samudrala, MD Carolina Neurosurgery & Spine Associates Southeaster Spine Institute USC University Hospital Scott L. Blumenthal, MD Kee D Kim, MD Douglas Slaughter, MD Texas Back Institute UC Davis School of Medicine Dennis Crandall, MD Sonoran Spine Center Timothy Burd, MD Leon K. Liem, MD Nebraska Foundation for Spinal Research The Queen’s Medical Center, Neurological John B. Sledge, MD Institute Sports Medicine North Orthopaedics Surgery John Demakas, MD Deaconess Medical Center Harry Lockstadt, MD Michael L. Swank, MD Bluegrass Musculoskeletal Research Cincinnati Orthopedic Research Institute John Dusseau, MD Daniel Robertson, MD Donald MacKay, MD John S. Thalgott, MD Lee Memorial Hospital, Lee Neurosurgery Michael Daubs, MD Center for Diseases & Surgery of the Spine Orthopedic Specials of Nevada Jeffrey S. Fischgrund, MD Antoine Tohmeh, MD William Beaumont Hospital Orthopaedic Specialty Clinic of Spokane Joseph Maroon, MD Edmund H. Frank, MD William Welch, MD Alex Vaccaro, Md, F.A.C.S. Oregon Health & Science University UPMC Presbyterian University Hospital Rothman Institute Robert H. Horne, MD Robert Masson, MD Jeffrey C. Wang, MD Physicians’ Research Options Southeastern Clinical Research UCLA Medical Center Ken Y. Hsu, MD Anthony Matan, MD Jim A. Youssef, MD James Zucherman, MD SUNY Upstate Medical University Durango Orthopedic Associates St. Mary’s Spine Center  Clinical Publications SPINE Volume 37, Number 8, pp 631–641 ©2012, Lippincott Williams & Wilkins Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. Rhyne AL, Blumenthal SL, Frank EH, Hsu KY, Kim KD, Youssef JA, Wang JC, Arnold P, BenDebba M, Block KM, Juarez TG, Chiacchierini RP, Ehmsen RJ, Krelle JS, diZerega GS; Oxiplex Clinical Study Group. STUDY DESIGN: Prospective, randomized, blinded clinical trial. OBJECTIVE: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy. CONCLUSION: The data demonstrates improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation. Consistent Clinical Benefit with Oxiplex®  Across all measures, greater average improvement at 6 months in Oxiplex-treated group vs. surgery-alone control group:  Leg pain  Back pain  Leg weakness  Physical symptoms  Patient satisfaction  Disability days  Activities of daily living Benefits of Oxiplex® vs. Surgery Alone Oxiplex Significantly Reduced Leg and Back Pain at 6 Months in Subjects with Severe Baseline Back Pain Fewer Disability Days in Oxiplex® Subjects Disability days = Days when a patient is completely disabled by his/her lower back condition. Greater Satisfaction in Oxiplex® Subjects Significantly Greater Patient Satisfaction at 6 Months in Subjects with Severe Baseline Back Pain  Fewer Re-Operations in Oxiplex® Group U.S. Oxiplex Study At 6 Months Oxiplex Group Surgery Alone (n=177) (n=175) # Re-operations 1 6 %.6% 3.4% Six-fold fewer re-operations in patients treated with Oxiplex vs. surgery-only controls Study Summary  Less residual leg and back pain  Fewer neurological symptoms  No post-op CSF leaks  Fewer re-operations  Enhanced patient satisfaction  Less disability days  Improvement in daily activities Oxiplex® Independent Studies  All Confirm Safety & Efficacy Peer-Reviewed Oxiplex® Publications  All Confirm Safety & Efficacy Benefits:  Exceptional safety  Designed and indicated for use in spine surgery  Safety and performance established in spine surgery  Ready to use  Fast application, thorough coverage  Colorless (to allow clear view of surgical field and neural elements)  Absorbable Benefits:  Protects the Procedure  Separates and coats tissues  Barrier to biochemical irritants  Reduces adhesions  Optimizes Healing  Moderates pain and symptoms  Fewer adhesions  Easier re-operations  Improves Outcomes  Minimizes leg and back (spine) pain  Lower re-operation rates  Why Use Oxiplex®?  The leading adhesion barrier for spine surgery worldwide: 600,000 units distributed worldwide!  Exceptional safety record  Synthetic biomaterial / No animal by-products  Effective Fewer adhesions Better outcomes Easier re-ops  Easy to use gel / no mixing required  No refrigeration required  Fast, simple application Competitors - Hyalobarrier®  Hyalobarrier® is composed of an aqueous gel of ACP200®, an original auto- cross-linked ester of hyaluronic acid. It is a barrier for protecting and separating tissues.  Hyalobarrier® is easy to manipulate during procedures. The product completely degrades within 7 days by following the natural pathway of hyaluronic acid.  Hyalobarrier® has a watery consistency and therefore, the product doesn’t stay where placed.  Storage conditions (2°- 8°C)  Requires refrigeration! Competitors - Guardix  GUARDIX SOL is manufactured by Hamni Medicare (Korea)  Adhesion barrier formulated as a viscous solution (gel):  Comprised of Hyaluronic Acid (HA) and Carboxymethyl Cellulose (CMC)  Sterile, transparent, colorless  Slowly resorbed within 14 days  Excreted from the body in less than 28 days  Indicated in:  General Surgery  Laparoscopic surgery  Gynaecological surgery  Neurosurgery  Spine surgery  ENT (Ear-Nose-Throat) surgery  Orthopaedic surgery  Minimal clinical evidence Competitors - DuraSeal Sealant System  DuraSeal Sealant Technology  Mix of 2 separate solutions Polyethylene glycol (PEG) ester solution Trilysine amine solution  Indications for use As an adjunct to sutured dural repair during cranial surgery to provide watertight closure  Disadvantages Complicated to assemble & use Mist & hydrogel require pre-mixing May swell up to 50% in any direction Competitors - Fat Grafts  Autologous pedicle or subcutaneous fat  Graft shrinks but is not usually absorbed  No clinical benefit for adhesion prevention  Complications include…  Necrosis  Excessive fibrosis  Prevention of bone healing  Compression of spinal cord by migration of fat into the epidural space