The Shield advantage: Minimizing nerve manipulation Bone Bone Ligament Ligament Nerve Link Link Nerve Safety and Efficacy Model configurations for multiple approaches Back 3 Dreal™ System
Safety Assessment: Incidental Dural Tears A common complication of spine surgery that are usually treated and heals uneventfully, yet may serve as an indicator for safety # Incidental dural tears Ref. # cases Hi-speed Bone General Dreal TM drills Scalpel incidence 272 12 Published 301 8 literature 774,296 19677 Carevature (*) 550 ** 2 Incidence 0.3% 4.4% 2.6% 2.54% Back (*) Case monitoring; (**) Sep. 2017 4 Dreal™ System
Link Link Cervical Decompression Back 5 Dreal ™ System
Case Series (IL) • 36 patients, ages 42-74, were treated for osteophyte removal (1-4 levels) during ACDF or ACCF surgery • All procedures were uneventful and without major complications. At follow-up, patients showed improvement in pain and motor ability • Average operation length was 76 minutes with minimal blood loss. Average length-of-stay was 3.9 days Back 6 Carevature Presentation
Dens Tumor Removal Back • 62YO male with a vertebral tumor of the base of the Dens • Suffered radiculopathy of the right arm; operated for an ACDF procedure on the C5-C6 level • Entire tumor removal using the device required less than two minutes; operation length was 63 minutes • 200ml estimated blood loss Carevature Presentation 7
Uncusectomy and Foraminotomy in ACDF Back 61 Yrs Female Resected part of Uncus Hand pain Decompressed Foramen 8 Dreal ™ System
Laminotomy Link Link Bone-sparing Lumbar Decompression Ipsi-lateral Contra-lateral External Back 9 Dreal™ System
Demonstrating a Fusion-alternative Previous Skin-to- Patient Condition Procedure EBL Results Discharge surgery Skin time Leg pain, Lumbar L5-S1, L+R, Pain 82 YO M 30min ~0 2 days L+R fusion 2003 foraminotomy free Lumbar L5-S1, R, Pain 66 YO M Leg pain 22min Next day fusion 2011 foraminotomy free L4-5, L+R, Pain 89YO M Leg pain - laminotomy and 31min ~0 Next day free foraminotomy Laminectomy L2-3, L3-4, R, Pain 70YO M Leg pain, R 48min 2 days 2013 foraminotomy free Back 11 Dreal ™ System
Case Series [US] • Two independent centers, 49 patients; open and MIS approach • Lumbar and cervical spinal fusions, and foraminotomies • All procedures were successful, without major complications • Sufficient bone removal in 91% of the procedures • In 94% of the procedures that the use of the device reduced procedure time • Average number of device passes required for each foraminotomy was 1.77, with an average device-use duration of 2.2 minutes for each foramen. • Osteophyte removal required, on average, 1.6 passes and 3.5 minutes Back 12 Carevature Presentation
Back Link Thoraco-Lumbar TLIF 19min. procedure time saving, on average Nucleus is Milgram, et.al, A new high-speed curved device facilitating TLIF through removed in unilateral facetectomy approach few large fragments 13 Dreal ™ System
TLIF Cadaver Study Midline Midline Dreal ™ Standard Tools Back 10 device passes 41 device passes 14 Carevature Presentation
Safe and Effective Osteophytes removal Back Cervical Lumbar Pre-op Post-op 15 Dreal ™ System
Dreal ™ Model Selection Guide Back 16 Dreal ™ System
Upcoming: MIS Line Back 17 Carevature Presentation
OR Setup Guide Refer to the Dreal TM Instructions for Use (IFU) for detailed instructions on motor and irrigation setup 50 cc or larger IV bag Motor handpiece (foot operated) Luer lock Roller-clamp should be placed in the sterile field, Standard Sterile tubing ; within the surgeon’s reach; length should allow the Dripping rate of ~1 drop/sec provides enough surgeon to work irrigation to keep the tip from heating and allows conveniently or an debris to wash away extension may be used Back 25 Dreal ™ System
Driving the Dreal TM Electric or pneumatic handpiece having an E ( ‘ micro ’ ) standard coupling, as per ISO 3964 * Handpiece is not supplied Compatible driving systems cleared for Neuro and Spine surgery in the US: • Stryker CORE with Micro Drill or Rem B handpieces • Medtronic Midas Rex Legend (with ‘ Intra Coupling ’ adapter) • DePuy Synthes Anspach ™ Xmax, MicroMax Plus, eMax 2/eMax 2 Plus (with ‘ Intra Coupling ’ adapter) • Aesculap microspeed (with GD678/679 hanpiece) Back 26 Dreal ™ System
Packaging Models XL75FU Models 3S45XX 19mm 12mm 45 ° How supplied 75 ° • The Dreal ™ is a single-patient, single-use device, supplied sterile in a double pack pouch. • The Dreal ™ cannot be re-sterilized • The Dreal ™ is not supplied with the motor • The Dreal ™ shelf life are 5 years. • Packaging dimensions: 400mmX200mmX30mm, weight 140grm Back 27 Dreal ™ System
THANK YOU Contact: contact@carevature.com Website: www.carevature.com Youtube: https://www.youtube.com/user/CarevatureMedical U.S. Customer Service: 855-201-5770 Back
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