Safety and Efficacy Model configurations for multiple approaches - - PowerPoint PPT Presentation

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Safety and Efficacy Model configurations for multiple approaches - - PowerPoint PPT Presentation

Sep 12, 2023 254 likes •454 views

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

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SLIDE 1
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Dreal™ System 3

Safety and Efficacy

Model configurations for multiple approaches

Bone

Ligament

Nerve Bone

Ligament

Nerve

The Shield advantage: Minimizing nerve manipulation Back Link Link

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SLIDE 3

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

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Ref. # cases # Incidental dural tears

DrealTM Hi-speed drills Bone Scalpel General incidence

Published literature

272 12 301 8 774,296 19677

Carevature(*)

550** 2

Incidence

0.3% 4.4% 2.6% 2.54%

(*) Case monitoring; (**) Sep. 2017 Dreal™ System

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SLIDE 4

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Cervical Decompression

Dreal™ System

Back Link Link

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SLIDE 5

Case Series (IL)

Carevature Presentation

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  • 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

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SLIDE 6

Dens Tumor Removal

  • 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

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SLIDE 7

Uncusectomy and Foraminotomy in ACDF

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Resected part

  • f Uncus

Decompressed Foramen

61 Yrs Female

Hand pain

Dreal™ System

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SLIDE 8

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Lumbar Decompression

Dreal™ System

Ipsi-lateral Contra-lateral External Bone-sparing Back Link Link Laminotomy

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Demonstrating a Fusion-alternative

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Patient Condition Previous surgery Procedure Skin-to- Skin time EBL Results Discharge

82 YO M Leg pain, L+R Lumbar fusion 2003 L5-S1, L+R, foraminotomy 30min ~0 Pain free 2 days 66 YO M Leg pain Lumbar fusion 2011 L5-S1, R, foraminotomy 22min Pain free Next day 89YO M Leg pain

  • L4-5, L+R,

laminotomy and foraminotomy 31min ~0 Pain free Next day 70YO M Leg pain, R Laminectomy 2013 L2-3, L3-4, R, foraminotomy 48min Pain free 2 days

Dreal™ System

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SLIDE 10

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

Carevature Presentation

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SLIDE 11

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Thoraco-Lumbar TLIF

Dreal™ System

  • 19min. procedure time saving, on average

Milgram, et.al, A new high-speed curved device facilitating TLIF through unilateral facetectomy approach

Nucleus is removed in few large fragments Back Link

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SLIDE 12

TLIF Cadaver Study

Carevature Presentation

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Dreal™

10 device passes Midline Midline

Standard Tools

41 device passes

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SLIDE 13

Safe and Effective Osteophytes removal

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Pre-op Post-op

Cervical Lumbar

Dreal™ System

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SLIDE 14

Dreal™ Model Selection Guide

Dreal™ System 16

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SLIDE 15

Upcoming: MIS Line

Carevature Presentation

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OR Setup Guide

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50 cc or larger IV bag Standard Sterile tubing; length should allow the surgeon to work conveniently or an extension may be used Roller-clamp should be placed in the sterile field, within the surgeon’s reach; Dripping rate of ~1 drop/sec provides enough irrigation to keep the tip from heating and allows debris to wash away Luer lock Motor handpiece (foot operated)

Refer to the DrealTM Instructions for Use (IFU) for detailed instructions on motor and irrigation setup Dreal™ System

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SLIDE 17

Electric or pneumatic handpiece having an E (‘micro’) standard coupling, as per ISO 3964 * Handpiece is not supplied

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Driving the DrealTM

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)

Dreal™ System

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SLIDE 18

Models 3S45XX

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Models XL75FU

19mm 75° 12mm 45°

How supplied

  • 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

Packaging

Dreal™ System

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SLIDE 19

THANK YOU

Contact: contact@carevature.com Website: www.carevature.com Youtube: https://www.youtube.com/user/CarevatureMedical U.S. Customer Service: 855-201-5770

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