L DISQ Lead to the Disc Cure Spot WHAT IS L DISQ and L DISQ and L DISQ C are minimally-invasive devices for percutaneous disc decompression using radiofrequency energy. L DISQ and L DISQ C are intended to be placed into the posterolateral or posterocentral area in the disc to remove a herniated nucleus pulposus or a coagulate disc material in the area. LDISQ_C 0518.indd 1 2012-07-09 오후 4:13:40
L DISQ Lead to the Disc Cure Spot Indication Radicular pain with herniated nucleus Discogenic pain with protrusion Axial back pain with central herniated nucleus pulposus Herniated Disc Degeneration(HDD) L DISQ For Lumbar For Cervical MPU(Multi Power Unit) LDISQ_C 0518.indd 2 2012-07-09 오후 4:13:47
Lead to the Disc Cure Spot L DISQ PART# PD01 PD02 PD03 PD04 PD05 PDN1010 Cath-6Fr-150 PDN1020 Cath-16G-150 DESCRIPTION L DISQ 25mm L DISQ 45mm L DISQ 15mm L DISQ 9mm L DISQ 35mm Polymer Catheter 150mm Metal Catheter 150mm CUSTOM-ORDER PART# PC01 PDN1010 Cath-6Fr-80 DESCRIPTION L DISQ C 17mm Polymer Catheter 80mm MPU PART# MPU PD2020 DESCRIPTION RF GENERATOR RF FOOT-SWITCH PD2030 MANIPULATOR CONNECTOR CABLE LDISQ_C 0518.indd 3 2012-07-09 오후 4:13:48
L DISQ Lead to the Disc Cure Spot L DISQ and L DISQ C are designed to effectively and safely perform lumbar and cervical discectomy procedures. Navigatable Electrode Tip Effective on the major HDD pains (Radicular pain & Discogenic pain) Functions in one unit (Ablation, Coagulation, Stimulation) LDISQ_C 0518.indd 4 2012-07-09 오후 4:13:50
Lead to the Disc Cure Spot Treatment (Ablation, Bipolar Coagulation) Using fluoroscopic guidance, with AP and lateral views of the targeted disc, navigate the electrode tip to the target area. When the electrode tip approaches the target, activate the ablation mode by pressing the ablation button and selecting the appropriate power level to remove the pathologic tissue. Diagnosis (Stimulation) Attach the plate to the patient s body. Navigate the electrode tip to the target area of annular tear. When the electrode tip approaches the targeted points, select the stimulation mode by pressing the stimulation and power control button. If the patient feels a sharp, or sudden aching sensation in the back or the buttock with very low voltage of electrical stimulation, a pathological pain of the disc has been located. Stimulus strength can be controlled by adjusting voltage and frequency controls. Treatment (Monopolar Coagulation) When a putative pain generator is located by electrical stimulation, select the monopolar coagulation mode by pressing the coagulation control and adjusting the stimulus strength. And then coagulate the tissues. Repeat the procedures of the electrical stimulation and coagulation for each region with a painful annular tear, neo-innervation or sensitized nociceptors. Cautions Prior to use, ensure all package inserts, warnings, cautions, procedure technique manuals, and instructions for use are read and understood. The L DISQ and L DISQ C are supplied sterile and are intended for SINGLE USE ONLY. DO NOT clean, resterilize, or reuse the L DISQ and L DISQ C, which may damage or compromise performance of the device, resulting in product malfunction, failure, or patient injury. Cleaning, resterilization, or reuse may expose patient to risk of transmitting infectious disease. Use of unauthorized cables may damage of the RF Generator and the L DISQ and L DISQ C. Maintain the lowest power level necessary to achieve the desired effect. 4 5 LDISQ_C 0518.indd 5 2012-07-09 오후 4:13:50
L DISQ Lead to the Disc Cure Spot Control the direction of the tip Pre OP L4/5_AP View L4/5_Lateral View Post OP L5/S1_AP View C6/7_Lateral View Test of plasma treatment on a cadaver. There are no dark marks left in the disc and the lesion seems to have evaporated. Cadaveric Disc, L3/4, Male, Age 59 LDISQ_C 0518.indd 6 2012-07-09 오후 4:13:56
Lead to the Disc Cure Spot Radicular Pain 20 patients Measure : VAS, ODI, RM, SF-36v2 Period : Pre-and post -1 week, 1, 3, 6 months Gender Male : Female 15 : 5 Age(year) Mean ± SD 42.2 ± 10.2 Range 23 to 67 Duration of symptoms(month) Mean±SD 7.2 ± 4.0 Range 3 to 15 Level of targeted disc(cases) L3/4 2 L4/5 13 L5/S1 5 Discogenic Pain 27 patients : Low back and related lower limb pain Measure : VAS, ODI, RM, SF-36v2 Period : Pre-and post -1, 4, 12 weeks Gender Male : Female 19 : 8 Age(year) Mean ± SD 40.7 ± 15.3 Range 16 to 68 Duration of symptoms(month) Mean±SD 6.5 ± 4.0 Range 1 to 14 Level of targeted disc(cases) L3/4 3 L4/5 18 L5/S1 6 Configuration of targeted disc Focal protrusion 7 Extrusion 20 Ref : Pain Medicine 2011; 12 : 370-376 (Impact Factor : 3.06) 6 7 LDISQ_C 0518.indd 7 2012-07-09 오후 4:13:58
REV01. 20120510 L DISQ and L DISQ C are indicated for ablation of disc material to treat patients with contained disc herniations. L DISQ and L DISQ C can give diagnosis & treatment to the discogenic pain by stimulating and coagulating the nociceptors in the painful disc. EC REP Obelis s.a Boulevard General Wahis 53 1030 Brussels, BELGIUM Tel : +(32) 2.732.59.54 Fax : +(32) 2.732.60.03 E-Mail : mail@cbelis.net ISO13485 www.youic.com www.ldisq.com 20, Sandan-ro 76beon-gil, Uijeongbu-si, Gyeonggi-do, 480-859, Korea Phone +82 31 852 0102 Fax +82 31 852 9025 E-mail : information@youic.com Copyright U&I Corp. All Rights Reserved. LDISQ_C 0518.indd 8 2012-07-09 오후 4:14:00