OSTEOCOOL ] PRODUCT PORTFOLIO

Transcription

1 OSTEOCOOL ] PRODUCT PORTFOLIO REGIONAL ONCOLOGY LEADERS PMD

2 OBJECTIVES Discuss the current indications and contraindications for the OsteoCool RF Ablation System Describe the product portfolio for the OsteoCool RF Ablation System Differentiate the OsteoCool RF Ablation System from other available systems PMD

3 INDICATIONS FOR USE OSTEOCOOL RF ABLATION SYSTEM OsteoCool RF Ablation System Indications Intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. Contraindications Contraindicated in patients with heart pacemakers or other electronic device implants. Contraindicated in vertebral body levels C1-C7. OsteoCool Bone Access Kits Indicated for percutaneous access to bone. OsteoCool Independent Thermocouple Intended for measuring tissue in temperature throughout an RF ablation procedure. Source: Instructions for Use Documents. PMD

4 OSTEOCOOL RF ABLATION SYSTEM FOR THE PALLIATIVE TREATMENT OF SPINAL METASTASES Capital Equipment Disposables RF Generator Probes & Tube Kits Pump Connector Hub Bone Access Kits Independent Thermocouple PMD

5 CAPITAL EQUIPMENT OSTEOCOOL RADIOFREQUENCY GENERATOR Generator Screen Displays: Ablation Time (counting down), Temperature ( C), Power (Watt) and Impedance (ohms) Ablation Power Button Starts, pauses and stops ablation 40W Radiofrequency Generator (20W/probe) Touch screen user interface Reads default setting for probes Adjustable by user if necessary Automatic shut off when ablation complete USB port to download performance data PMD

6 CAPITAL EQUIPMENT OSTEOCOOL CONNECTOR HUB Connects to Generator 2 Probe Ports 2 ITC Ports Allows simultaneous use of two probes Includes four ports Two RF Ablation Probes Two Independent Thermocouples (ITC) Ports labeled A and B correspond with A and B displayed on generator Smart technology detects Probe size and data Temperature via thermocouple PMD

7 CAPITAL EQUIPMENT OSTEOCOOL PUMP Peristaltic pump compresses tube to move fluid Pumps run independently Pumps mount below generator Requires 1 burette/sterile water per pump (A and B) Side hooks hold burettes Open lid to insert tubing Arrows direct how to load tubing PMD

8 DISPOSABLES OSTEOCOOL RF ABLATION PROBES Internally-cooled and bipolar 17 G probes work with variety of cannula sizes Two cables one delivers RF energy; the other circulates sterile water Sterile, single use device, for use within a single vertebral body Probe size Identified by Active Tip Color-coded by size Default ablation times vary by probe size Smart chip tells the generator probe size Active Tip A: Proximal Electrode B: Distal Electrode RF Cable Connects to Connector Hub A A B Cooling Line (Connects to Tube Kit) Proximal Radiopaque Band Distal Thermocouple PMD

9 DISPOSABLES OSTEOCOOL RF ABLATION PROBES PROBE ACTIVE TIP 7mm ABLATION ZONE SIZE AND DEFAULT TIME 11x10mm 6:30 minutes 10mm 17x13mm 7:30 minutes 20mm 29x21mm 15:00 minutes 9 PMD

10 DISPOSABLES OSTEOCOOL TUBE KIT 1 tube kit included for each probe Holds 70 ml sterile water, room temperature Closed-loop system delivers cooled water to probe and returns to burette Connects via Luer locks to probe Sterile, single use device Burette and Removable Lid or filling option via Lid Port Fill Lines Port for filling with syringe PMD

11 DISPOSABLES BONE ACCESS KITS AND INDEPENDENT THERMOCOUPLE Bone Access Kits 1 cannula + 1 stylet + 1 drill OCN002 10G 090 (Size 2) Independent Thermocouple 1 thermocouple + 1 cannula OCN003 8G 090 (Size 3) OCN001 28G 180mm 20G Cannula) OCN005 13G 100 (Vertebroplasty) PMD

12 RF TECHNOLOGY DIFFERENTIATORS PMD

13 PROBE DESIGN EVOLUTION NON-COOLED VS. COOLED RF TECHNOLOGY RF Heating Challenges Direct heating of tissue will commonly dehydrate (desiccate) the tissue or can even char (charcoal barrier) Desiccated tissue needs to rehydrate before it can accept more heat. Charred tissue blocks further ablation and is irreversible. Ablation will stop growing and so energy should no longer be applied. Overcoming RF Challenges: Benefits of OsteoCool Circulating sterile water cools the electrode and carries heat away from tissue in direct contact with the electrode, called heat sink In hydrated and non-charred tissue ablation will continue to grow Because tissue is not dehydrating or charring, time and power can increase without causing problems. The more time and power without tissue temperature complications allows for larger volume lesions compared to noncooled probes PMD

14 PROBE DESIGN EVOLUTION NON-COOLED VS. COOLED RF TECHNOLOGY Comparison of Cooled vs. Non-Cooled ablation in tissue model NON-COOLED COOLED Internal Data on File PMD

15 PROBE DESIGNS HAVE EVOLVED OVER TIME TEMPERATURE CONTROL WITH THERMOCOUPLE INTERNAL THERMOCOUPLE Internal temperature sensor Monitors temperature where probe contacts tissue Pause ablation gives tissue time to rehydrate Stop ablation to prevent irreversible charring Continue ablation BENEFITS OF TEMPERATURE CONTROL WITH OSTEOCOOL RF ABLATION Delivers a slow ramp up to target temperature Continuously monitors temperature Moderates power to maintain temperature Automatically pause ablation when tissue complications indicated - measured by impedance Source: OsteoCool User Manual PMD

16 OSTEOCOOL PROBE DESIGN SUMMARY BIPOLAR: Energy passed between two electrodes grows to create an energy field WATER-COOLED throughout shaft, cools where the electrodes touch tissue TEMPERATURE CONTROLLED by maintaining 70 o C at the distal tip of the probe, Temperatures may reach o C between electrodes System temperature read out reflects approximately 20 o C less than highest potential tissue temperature. 70 o Celsius Source: OsteoCool User Manual o Celsius PMD

17 OSTEOCOOL IMPEDANCE MEASUREMENT APPROACH FOR EFFECTIVE ABLATION IMPEDENCE MEASUREMENT A high impedance indicates that tissue may be desiccating or charring OR the cortical wall is involved. OSTEOCOOL IMPEDANCE CUTOFF ALGORITHM System automatically pauses RF delivery if impedance is too high to allow tissue to rehydrate. The RF delivery may pause and restart multiple times. Occurs when impedance is 200 ohms above the baseline impedance. Automatic pausing RF is the system s way of detecting high impedance and adjusting to temporarily stop or reduce the energy output of the system. Source: OsteoCool User Manual 17 PMD

18 SUMMARY Internally-cooled and bipolar probes Simultaneous use of two probes Variety of probe and bone access tool options Generator monitors temperature and moderates power to maintain 70 o C at the distal tip of the probe Independent thermocouple for use near critical structures Impedance Cut-off Algorithm automatically pauses RF delivery 18 PMD

19 OSTEOCOOL ABLATION ZONE MAPPING AND TECHNIQUE SANDEEP BAGLA, MD VASCULAR INSTITUTE OF VIRGINIA WOODBRIDGE, VA ASSOCIATE PROFESSOR OF RADIOLOGY UNC CHAPEL HILL

20 GENERAL ABLATION PROCEDURE REVIEW Pre-Op Planning Films/ Tumor Mapping General or Local Anesthesia Image guided access into vertebral body via introducer Bone Ablation Procedure Create channel for insertion of probe Insert Probe through cannula and Ablate (rec 6-15 min), Reposition as needed to cover tumor Remove probe Other Physician Directed Procedures if required Cannula keeps access open

21 ABLATION ZONE MAPPING BENEFITS OsteoCool Bone Access tools provide guided mapping when performing ablation near critical structures or when a specific zone is desired. Proper zone mapping will: Aid selection of appropriate probe size Help gauge ablation zones based on probe placement and trajectory Increase confidence based on the Posterior Precision demonstrated for procedures near the spinal canal Establish confidence in zones created near other critical structures 22 PMDXXXXXX-1.0

22 OSTEOCOOL BONE ACCESS KITS INTENDED FOR PERCUTANEOUS ACCESS TO BONE Osteo Introducer with Trocar tip Stylet 8, 10 and 13G options Precision Hand Drill with Color Markings on shaft Colors correspond to different OsteoCool RF Probe sizes available 23 PMDXXXXXX-1.0

23 ACCESS TOOL PLACEMENT OVERVIEW PLACING THE STYLET Distal tip of the Stylet provides an indicator beyond which ablation should not occur posteriorly Trocar Tip Stylet Posterior Boundary, Posterior Line 25 PMDXXXXXX-1.0

24 ACCESS TOOL PLACEMENT OVERVIEW PLACING THE DRILL Distal tip of the drill provides an indicator beyond which ablation should not occur anteriorly Color lines dictates size of probe Anterior Boundary, Anterior Line PMDXXXXXX-1.0

25 ACCESS TOOL PLACEMENT OVERVIEW EXAMPLE OF MAPPED ABLATION ZONE Probes do not extend past drill tip Ablation will grow to where the drill tip was stopped (when stopped on colored line) IFU indicates to keep 10mm margin between zone critical structures Anterior & Posterior Boundaries 27 PMDXXXXXX-1.0

26 SINGLE PROBE ZONE MAPPING Place distal tip of stylet at the posterior edge of the tumor. Drill through the tumor until the distal tip of drill aligns with or goes beyond the anterior edge of the tumor. Select the appropriate RF probe for tumor and ablate. If desired drill depth does not line up with any of the drill color markers, attempt to size up to ensure complete tumor coverage by predicted ablation zone or retract if too deep. 29 PMDXXXXXX-1.0

27 DUAL PROBE ZONE MAPPING Place distal end of stylet at the posterior edge of the tumor. Repeat on contralateral side. Drill through the tumor until the distal tip of drill aligns with or goes beyond the anterior edge of the tumor. Remove drill and repeat on contralateral side. Select the appropriate RF probes for tumor and ablate simultaneously. Distal stylet tips create posterior line Distal drill tips create anterior boundary If desired drill depth does not line up with any drill color markers, size up to ensure complete tumor coverage or retract if too deep. 30 PMDXXXXXX-1.0

28 ABLATION PROBE PLACEMENT ZONE CONCEPTS BASED ON DUAL PROBE USE 7mm Probes Probe Distance and Ablation Zone Example Scenarios 8-10mm probe distance tested / shown at 70 degrees angulation 10mm Probes 20mm Probes Based on Bench Data Work. Internal Documentation on File. 31 PMDXXXXXX-1.0

29 INTRODUCER DETERMINES NEED FOR SPACER PROBES PACKAGED WITH 18MM SPACER ON PROBE SHAFT Provides safe distance between proximal electrode and the distal tip of working cannula for Size 2 and Size 3 cannulas. User should confirm fluoro before activating RF Spacer Safe distance Provides press-fit feel - user knows the probe is fully seated. Note: A spacer is not used with 13g Bone access tools and needs to be removed. Physician should ensure probe is flush with proximal cannula port. 32 PMDXXXXXX-1.0

30 INTRODUCER DETERMINES NEED FOR SPACER PROBES PACKAGED WITH 18MM SPACER ON PROBE SHAFT Size 2 & 3 with Spacer OCN002 OCN mm 13G (VP) without Spacer OCN PMDXXXXXX-1.0

31 ACCESS TOOLS AND PROBE MEASUREMENTS REFERENCES Active Tip Length Cannula Drill Tip (A) Probe Tip (B) Drill Overage (C) 11x10mm 7mm 186mm OCN002 & 003 OCN005 Drill protrusion from cannula when seated at corresponding color 18.5mm 16.4mm Probe protrusion from cannula when fully seated 14.8mm 12.6mm Measurement of distance between seated drill & probe 3.7mm 3.8mm 17x13mm 10mm 190mm OCN002 & 003 OCN mm 21.3mm 19.0mm 16.8mm 4.1mm 4.5mm 29x21mm 20mm 202mm OCN002 & 003 OCN mm 34.9mm 30.3mm 28.1mm 6.1mm 6.8mm Numbers reflect rounding. Note, the luer for OCN005 is not 100% fixed which can cause slight variability. A B C 34 PMDXXXXXX-1.0

32 THERMOCOUPLE PLACEMENT

33 INDEPENDENT THERMOCOUPLE INTENDED FOR MONITORING TISSUE TEMPERATURE Coaxial device, 28G thermocouple through 20G spinal needle Recommended for use when nearby structures need temperature monitoring Breached cortical wall Posterior canal Nearby nerve structures

34 PLACEMENT TECHNIQUE EXAMPLE KAMBIN S TRIANGLE Possible approach for placing thermocouple through tissues into the anterior wall of the spinal canal Technique used for lumbar transforaminal epidural injections Efficacious as subpedicular approach (for ESI) and useful when needle tip positioning in anterior epidural space is difficult. Park JW, Nam HS, Cho, SK et al. Kambin s Triangle Approach of Lumbar Transforanimal ESI with Spinal Stenosis. Ann Rehabil Med 2011; 35: PMDXXXXXX-1.0

35 RETRACT FUNCTION 38

36 RETRACT FUNCTION OPTIONAL STEP TO ABLATE TRACK Uncooled RF energy delivered to probe, reaching up to 95 o C Ablation zone forms immediately near probe (non-spherical shape) Probe and cannula should remain connected and removed as a unit Energy will stop when probe electrode comes in contact with the cannula

37 SUMMARY The OsteoCool Bone Access Tools uniquely aid the physician in ablation zone mapping and probe size selection. Stylet and drill placement indicate anterior and posterior ablation boundaries Treatment for Posterior Tumors Single ablation without repositioning Angulation and 8-10mm distance between probe tips will yield largest ablation zone Probe is visible under imaging which provides visual confirmation of probe placement Independent thermocouple available when nearby structures need temperature monitoring

38 2015 MULTIDISCIPLINARY CONSENSUS ALGORITHMS 42 PMD

39 Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 43 PMDXXXXXX-1.0

40 ALGORITHMS FOR MANAGING METASTATIC SPINE DISEASE A. ASYMPTOMATIC SPINAL METASTASES Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 44

41 ALGORITHMS FOR MANAGING METASTATIC SPINE DISEASE B. UNCOMPLICATED PAINFUL SPINAL METASTASES Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 45

42 ALGORITHMS FOR MANAGING METASTATIC SPINE DISEASE C. STABLE PATHOLOGICVERTEBRAL COMPRESSION FRACTURE Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 46

43 ALGORITHMS FOR MANAGING METASTATIC SPINE DISEASE D. UNSTABLE PATHOLOGIC VERTEBRAL COMPRESSION FRACTURE Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 47

44 ALGORITHMS FOR MANAGING METASTATIC SPINE DISEASE E. UNSTABLE PATHOLOGIC VERTEBRAL COMPRESSION FRACTURE Wallace AN, Robinson CG, Meyer J et al. The Metastatic Spine Disease Multidisciplinary Working Group Algorithms. The Oncologist. 2015;20: Reproduced with permission from The AlphaMed Company Inc. 48

45 CLINICAL STUDIES 49 PMD

46 RF ABLATION RFA AND RADIATION: SYNERGISTIC? 15 pts RFA + RT (20Gy in 5 fractions) 30 pts RT 5/15 (33%) vertebrae RFA + RT; 2/30 (6.6%) RT alone Pelvis accounted for Majority Baseline VAS 6.5 (RT) and 6.3 (RFA + RT) Key Point RFA & RT May Provide Better Results than RT Alone Di Stasio M, Zugaro L. Gravina GL, et al. A feasibility study of percutaneous Radiofrequency Ablation followed by Radiotherapy in the management of painful osteolytic bone metastases.. Eur Radiol Sep;21(9): doi: /s Epub 2011 May 1. 50

47 THANK YOU 51