Non-Surgical Multi-Purpose Therapeutic Device. ExtenTrac Elite. M3D [Multi-Directional Disc Decompression]

Transcription

1 Non-Surgical Multi-Purpose Therapeutic Device ExtenTrac Elite M3D [Multi-Directional Disc Decompression] The World s Most Versatile Multi-Functional 3D Therapeutic Device

2 Extentrac Elite is a patented, FDA cleared, multifunctional therapeutic device for treatment of patients suffering from severe debilitating low back pain and sciatica due to: Protruding or Herniated Intervertebral Discs Acute Facet Problems Degenerative Disc Disease ExtenTrac Elite s Difference Unlike conventional decompression tables which limit patient positioning to the horizontal and axial position, Extentrac Elite s M3D System (Multi-Directional Disc Decompression), enables decompression from multiple directions to accommodate painful postures. Implementation is regulated through manual controls or fully automated programmed cycles. Extentrac Elite s articulating leg assembly with integrated control switches provide precise 3D spine positioning and disc localization. This breakthrough patented technology provides opportunities to implement a wide range of clinically proven research -based treatment protocols. The clinician has the option of hands-on manually applied therapeutic procedures or fully automated computer driven decompression. Therapeutic Versatility M3D (Multi-Directional Disc Decompression) - freedom and flexibility to place the patient in flexion, extension, lateral flexion, gravitational, axial or antalgic positions prior to, or during decompression. M3D (Multi-Directional Disc Dynamics) - range of motion, joint mobilization, and therapeutic exercise with or without disc decompression. Extentrac Elite is rapidly becoming integrated into professional practices, hospitals, and major spine clinics worldwide. Physicians, chiropractors, and physical therapists may now provide clinically effective spinal decompression plus the ability to apply conventional and evidence-based therapeutic procedures with one device. Removed Mechanical Stress Disc Dynamic Therapy Hydration Nutrition Dissolution of Adhesions Manual Therapy Mobilization M3D Therapy Disc Decompression Therapy

3 Post-ExtenTrac Elite Intervention Pre-ExtenTrac Elite Intervention Post-Extentrac Elite Intervention Multi-level reduction in size of disc herniations. Now asymptomatic. Pre- Extentrac Elite Intervention Patient presenting sciatica and multi-level disc herniations. {IDP:: mmHg} Intradiscal PressureImpingement of of L5 L5 nerve {IDP : - 150mmHg} {IDP : - 00mmHg} Precipitous Reduction in Intradiscal Pressure Reduction in size and shape of Herniation and Re hydration As cyclical distractive forces are applied, an increase in intervertebral joint spacing and disc height occurs, producing a vacuum phenomenon helping to reduce the size and shape of the herniated disc - moving it away from the compressed nerve root while potentially enhancing nutrient diffusion to the disc through the vertebral endplates and annulus.

4 ExtenTrac Elite Evolution of Intervertebral Disc Decompression Surgical Non-Surgical Axial Decompression (Y axis) Multi-Directional Decompression (X, Y, Z axes) axis) Key Features 1 Fully Computer Automated or Manual Treatment Cycles. Fully Adjustable Contoured Underarm Supports. 3 Patient Hand Gripping Bar and Cushioned Hand Support D Adjustable Lumbar Assembly for Precise Spine Positioning and Lumbar Mediated Decompression. 3D Adjustable Leg Assembly for Precise Spine Positioning During Leg Mediated Decompression, Mobilization and Spinal Ranges of Motion Power Adjustable Overhead Exercise Bar with Patient Control Switches for Supervised Participation in Decompression, Therapeutic Protocols and Exercise. Adjustable Head/Thoracic Back Support Cushion Accepts Optional Cervical Accessory Decompression System. Numerous Belting Options with Friction-Free or Locked Lumbar Support Cushion. Split Table Design with Friction-Free Lumbar Support Fully Rotatable Patient Treatment Platform for Easy Patient Positioning Patient Hand Control Bar with Control Switches for Supervised Patient Participation in Decompression. Mouse Point and Click Control, and 15 Color Monitor for Fully Automated Decompression Cycles or Manual Control. Practitioner Leg Bar with Control Buttons For Precise Hands-On Manually Applied Therapeutic procedures At the heart of the M3D System is its lumbar and leg assemblies which enable the application of precise therapeutic decompression and evidence-based treatment protocols from multiple angles and directions in flexion, extension, lateral flexion, and axial positions prior to decompression.

5 Research Based Treatment Versatility Extentrac Elite s revolutionary M3D spine positioning system, enables the combination of research based therapeutic treatment postures coupled with decompression. When uniquely combined, by utilizing Extentrac during patient treatment, these individual therapeutic protocols and postures act synergistically to provide a rapid, more effective means of relieving low back pain. Flexion Positioning with Decompression - Supported Through Research Studies* Flexion positioning for reduction of disc pressure, increases the vertebral canal diameter, and reduces disc protrusion, while improving disc metabolism. Extension Positioning with Decompression - Supported Through Research Studies* Extension positioning facilitates forward migration of viscoelastic nuclear disc material and minimizes sciatica by reducing nerve root pressure. Axial Positioning with Decompression - Supported Through Research Studies* Axial positioning reduces internal disc pressure, increases vertebral canal diameter, reduces disc protrusion, and improves disc metabolism. Antalgic Patient Positioning Antalgic patient positioning is utilized for painless and effective treatment. The patient is placed in test postures prior to treatment on the Extentrac Elite. Optimal patient positioning requires evaluation for centralization and reduction of radiating sciatic pain. Therefore, the clinician has the ability, prior to decompression, to mimic structural distortion in the acute patient and mirror-image the spinal distortion in the subacute or chronic patient. Antalgic patient positioning in an L4 right lateral disc herniation *References to published research studies available upon request

6 ExtenTrac Elite Clinical Study* A practice based retrospective study of 133 patients with low back pain with or without radiculopathy utilizing the Extentrac Elite multi functional therapeutic device. Data for patient outcome measurement was based on numerical changes in the patient s VAS (Visual Analogue Pain Scale). VAS (0-10) or greater Outcome Measures No Pain - Successful Outcome Mild Pain - Fair Improvement Nagging/Uncomfortable - Minimal/Partial Improvement No Improvement Percentage Number of Patients VAS Outcome 91% 77% 14% 9% Pain Relief No Pain, VAS. 0-1 Partial Improvement, VAS-3 No improvement VAS 4-10 Patient Positions SUPINE PRONE GRAVITATIONAL ANTALGIC *Complete study available upon request

7 M3D Therapy Promotes Retraction of Herniated and Bulging Discs Reduces Pressure on Vertebral Joints Promotes Self Healing of Herniated and Damaged Discs Reduces Muscle Spasm Increases Electrolyte Diffusion to the Disc M3D Technology Enables 3 Dimensional Decompression Has Fully Automated or Manually Applied Research-Based Therapeutic Options Utilizes Supine or Prone Treatment Positions Vertically or Horizontally Is True Hands-On (Direct Manual Hand Contact) Evidence-Based ed Manual al Therapy Includes Joint Mobilization, Range of Motion and Therapeutic Exercise Has Manually Controlled Power Driven Flexion-Distraction, Coupled with Decompression Has Two Separate Decompression Systems - Leg or Lumbar Incorporates 3 Dimensional Vertical - Gravitational Procedures Technical Specifications 5 x 8 floor space minimum Platform Height Dimensions: (floor to top of thoracic cushion) Height Retracted (Lift function) 78 inches Height Extended (Lift function) 88 inches Width (Rectangular base) 9.5 inches Patient Platform Dimensions: (Leg bar to top of patient rotation frame) Length Retracted 79 inches (Lift function) Length Extended 89 inches (Manual Length Adjustment) Length Extended (Power Length Distraction Range) 88 inches Leg Assembly Y-Axis Distraction Range (powered) 9 inches Frictionless Release Range 9 inches Z-Axis Extension 31/ inches Table Weight: lbs. Maximum m Patient Load Capacity 350 lbs. Electrical Specification: Volts 110/10 0/40 Amps 15.0/7.5 Freq. 50/60 Hz Phase Single Upholstery Naugahyde

8 ISO 13485:003 CAN/CSA US FDA 510 (k) Protected under United States and International patents Advanced Back Technologies, Inc. 89 Cabot Court Suite F Hauppauge NY, USA Fax: info@extentrac.com Advanced Back Technologies, Inc. DCN