Integra Lifesciences Holdings Corporation · NASDAQ:IART
Integra Lifesciences — Investor Presentation
33 slides from Integra Lifesciences's investor presentation
Slide 1: MAYFIELD 2 System: Next Generation of Cranial Stabilization
MAYFIELD®2 System Next Generation of Cranial Stabilization Document for use in Europe, Middle-East & Africa only
Slide 2: Table of Content
MAYFIELD®2 System Table of Content 1. How is composed a MAYFIELD®2 System? 2. MAYFIELD®2 benefits 3. Components’ inspection 4. Service & Repair center Document for use in Europe, Middle-East & Africa only
Slide 3: Composition
MAYFIELD®2 System COMPOSITION MAYFIELD®2 is the next generation of cranial stabilization system which provides attachment from the operating room table to a Skull Clamp for rigid skeletal fixation or a Horseshoe Headrest for head stabilization. Operating room table fixation Patients'Head fixation A3
Slide 4: Main Benefits
MAYFIELD®2 System MAIN BENEFITS Ease of use* Precision* Withstands cleaning and decontamination processes** Product traceability (serial number) * In comparison with our current MAYFIELD® Cranial Stabilization System ** MAYFIELD2 Skull Clamp IFU 451A3059 Rev F/MAYFIELD 2 Base unit IFU 451A31
Slide 5: What are the main advantages of the System?
MAYFIELD®2 System What are the main advantages of the System? Document for use in Europe, Middle-East & Africa only
Slide 6: Materials
MAYFIELD®2 System MATERIALS Cast aluminium Powder coated for durability and endurance with high temperatures and harsh detergents. Stainless Steel Rigidity and endurance PEEK material Molded of composite glass infused Rigidity, durability and endurance against high temperatures and harsh clean
Slide 7: Provides Ease of use
MAYFIELD®2 System provides Ease of use Document for use in Europe, Middle-East & Africa only
Slide 8: Base Unit Ease of use
MAYFIELD®2 System / Base Unit Ease of use Quick & easy set up No tool required for support rods’ adjustments (Thumb knob). No pression adjustment required: locking handle adjustment preset. No risk to lose parts Transitional member permanently attached to the locking handle. Complete Set
Slide 9: Base Unit Ease of use: Support rods' adjustments
MAYFIELD® 2 System / Base Unit Ease of use Support rods’ adjustments Left Bracket may be adjusted along the Connecting Tube to allow the Support Rod to accommodate table receptacles spaced 5-1/8” to 8-1/4” (130mm to 209.5mm) apart. Document for use in Europe, Middle-East & Africa only
Slide 10: Skull Clamp Ease of use
MAYFIELD® 2 System / Skull Clamp Ease of use Ease of handling, positioning and removing PEEK thermoplastic material reduces skull clamp weight. (A1059 (metal): 1.32kg (2.93lb) / A3059 (Mayfield 2): 1.25kg (1.75lb)) Dual button ratchet release: only one hand needed to disengage and smoothly sli
Slide 11: Provides Precision
MAYFIELD®2 System provides Precision Document for use in Europe, Middle-East & Africa only
Slide 12: Base Unit Precision
MAYFIELD®2 System / Base Unit Precision Safety Self locking lever provides added locking mechanism when the system is locked in place. Self locking lever Document for use in Europe, Middle-East & Africa only
Slide 13: Skull Clamp Precision
MAYFIELD®2 System / Skull Clamp Precision Well known brand since 1968 Design based on modified MAYFIELD® skull clamp (A1059). Ease of application 15 additional Rocker Arm positions provide additional positioning angles for precise locking position and maximum access to the operative site.
Slide 14: Withstands Cleaning & Decontamination Protocol
MAYFIELD®2 System withstands CLEANING & DECONTAMINATION PROTOCOL Document for use in Europe, Middle-East & Africa only
Slide 15: Cleaning & Decontamination Protocol
MAYFIELD®2 System Cleaning & Decontamination Protocol Withstands cleaning and decontamination processes*: Ability to be autoclaved (132- 134°C) Wide range of pH detergents (from 3 to 11) Endures World Health Organization (WHO) Protocol for high infectious diseases decontamination Design ha
Slide 16: Clinical Applications & Benefits
MAYFIELD®2 System Clinical Applications & Benefits Clinical Applications / Patients’ positionings • Prone • Supine • Lateral • Park Bench • Sitting position with A1015 Crossbar Adaptor Benefits for Neurosurgeons Ease of application* Precision * Ligthweight Design Design based on modified MAY
Slide 17: Components' Inspection
MAYFIELD®2 System Components’ Inspection Document for use in Europe, Middle-East & Africa only
Slide 18: Components' Inspection
MAYFIELD® 2 System Components’ Inspection Always inspect instruments before and after use (refer to Instructions For Use for inspection) If a component appears damaged and/or does not seem to function properly: - do not use the device - Immediately send the instrument to our authorized Integra repai
Slide 19: Service & Repair Center
MAYFIELD® 2 System Service & Repair Center Document for use in Europe, Middle-East & Africa only
Slide 20: Service & Repair
MAYFIELD® 2 System Service & Repair For EMEA Service & repairs send all instruments to our Technical Service and Repair via Local Customer Service INTEGRA – TSR Halskestrasse, 9 40880 Ratingen Germany Phone: +49 2102 5535 6199 Document for use in Europe, Middle-East & Africa only
Slide 21: Document for use in Europe, Middle-East & Africa only
Document for use in Europe, Middle-East & Africa only
Slide 22: Back up
MAYFIELD®2 System – Back up - Adjustments and System stability - System Set up - Storage Document for use in Europe, Middle-East & Africa only
Slide 23: Set Up
MAYFIELD®2 System SET UP Operating room table fixation Patients 'Head fixation A3018 Swivel Adaptor (included with A3101 Base Unit) OR A3101 Base Unit A3059 Skull Clamp OPTIONAL: A3008 TriStar Adaptor Document for use in Europe, Middle-East & Africa only
Slide 24: Set Up Step 1: Adjustments & Stability Check
MAYFIELD®2 System / SET UP STEP 1: Adjustments & Stability Check* 1 Mount the Base Unit to the operating room table by aligning the two Support Rods with receptacles or in the NeuroGen Adaptor or Crossbar Adaptor. => Use the left bracket knob to adjust and secure the left bracket in position. Note:
Slide 25: Set Up Step 1: Adjustments & Stability Check
MAYFIELD®2 System / SET UP STEP 1: Adjustments & Stability Check* 3 Base unit Locking mechanism Keep fingers clear of hinge points when closing the Base Unit Lock Levers. It is recommended that the levers be closed using the palm of the hand. Confirm the Base Unit stability 4 by closing (connected t
Slide 26: Set Up Step 2: Direction for use
MAYFIELD®2 System / SET UP STEP 2: Direction for use* Once adjustments and stability check is done we can continue to set up the system Transitional Arm and Swivel Adaptor positioning Open the Locking Lever to position the Base Unit as desired. To free the Locking Lever, press the latch into the L
Slide 27: Set Up Step 3: Skull clamp application
MAYFIELD®2 System / SET UP STEP 3: Skull clamp application* (Neurosurgeons only) 1 Unlock the Index Locking Knob so the rocker arm can rotate freely 360 degrees. 2 Rotate the rocker arm into the desired position Perpendicular to the floor => prone or supine positions. Parallel to the floor => sittin
Slide 28: Set Up Step 3: Skull clamp application
MAYFIELD®2 System / SET UP STEP 3: Skull clamp application* (Neurosurgeons only) 5 Position the 2-pin rocker arm so the skull pins are equidistant from a center line of the head. 6 Seat the skull pins securely into the cranial table. Skull pins should enter the scalp at a 90-degree angle, perpendicu
Slide 29: Set Up Step 4: Fixation of the System
MAYFIELD®2 System / SET UP STEP 4: Fixation of the System* 1 Once the skull clamp is applied to the patient’s head, the surgeon will maneuver the patient to the surgical position that is required for the procedure. 2 The Base Unit (transitional arm) should be brought up for attachment to the skull c
Slide 30: Set Up Step 4: Fixation of the System
MAYFIELD®2 System / SET UP STEP 4: Fixation of the System* 3 Securely fasten the skull clamp to the base unit by attachment to the swivel adaptor. - Close locking lever. - Turn clockwise all locking knobs of other components of the base unit making certain all starburst teeth are fully meshed (where
Slide 31: Storage
MAYFIELD®2 System STORAGE Document for use in Europe, Middle-East & Africa only
Slide 32: Storage
MAYFIELD®2 System Storage* Base unit: No specific storage condition. Skull clamp: Store the Skull Clamp with the Index Locking Knob in the UNLOCKED position. This practice will provide the best performance from the knob. Index Locking mechanism * MAYFIELD2 Skull Clamp IFU 451A3059 Rev F/MAYFIELD
Slide 33: For more information or to place an order, please contact
For more information or to place an order, please contact: Integra LifeSciences Corporation 4900 Charlemar Drive, Bldg. A Sales & Marketing EMEA Cincinnati, Ohio 45227 - USA Integra LifeSciences Services (France) SAS Immeuble Séquoia 2 97 allée Alexandre Borodine Parc technologique de la Porte des A