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Product Training - Raj Sarkar, PM OsteoFlap ® System Overview.

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Presentation on theme: "Product Training - Raj Sarkar, PM OsteoFlap ® System Overview."— Presentation transcript:

1 Product Training - Raj Sarkar, PM OsteoFlap ® System Overview

2 Market Overview Several methods are usually utilized to achieve re-attachment of the cranial flap after a craniotomy: Plates and screws Steel wire sutures Clamping rachet designs OsteoFlap ®

3 Product Overview Indications: OsteoFlap™ is indicated for the re-attachment of the cranial flap after a craniotomy. Device Specification: Made of titanium alloy (6Al-4V) MRI compatible Available in 11mm, 17mm and 22mm disk diameters Two tools available for disk removal OsteoFlap ®

4 OsteoFlap ® Features & Benefits FeatureBenefit Titanium AlloyStrength & Biocompatibility Concave shapeConforms to shape of cranial surface Reduces soft tissue irritation Strength due to formed shape Recess formed to reduce potential fixation rod protruding into soft tissue Small, Fine threadsInfinite adjustability for adapting to flap thickness Narrow diameter chosen to allow for intra-kerf placement Threaded & welded into inferior plate for additional strength

5 Outward radiating slots on plate Flanged for flexibility in adapting to cranium interior Flanges also can conform independently and add rotation resistance of implant Plate thickness, 0.83mmMinimal invasion & protrudence into dura 3/4” Outer Diameter of ToolLarge diameter for ease of use, minimal effort required Grooves on Outer Diameter of Tool Easy grip with gloved fingers Instrument-free designNo instrumentation to be sterilized OsteoFlap ® Features & Benefits

6 Surgical Technique Implant Placement After the surgical intervention, position the OsteoFlap Cranial Flap Fixation Disks equally spaced on the dura. Position the inferior disk so that the anti-rotation tab on the inferior disk falls within the kerf width. Replace the bone flap, allowing it to rest between the inferior and superior disks. The superior disks are threaded down on each device with the use of the attached driver tool. Tighten the superior disk by pulling the rod in a superior direction with one hand, and turning the driver tool with the other hand (Fig. A). DO NOT secure any single device until all of the devices are loosely tightened and the flap is correctly oriented. Final tightening should be firm and represent the maximum force of the fingers. Avoid capturing soft tissue or debris between the disks and the bone. NOTE: If the tab on the superior plate is not in the kerf width when the device is secured, continue to turn the driver tool until the tab is in the kerf width. ANTI-ROTATION TAB DRIVER TOOL OsteoFlap ®

7 Surgical Technique Fig. B Once all the implants have been secured, rock the disposable driver tool in the direction of the arrows on the driver tool (Fig. B). The center rod should break clean. Dispose of the driver tool and broken center rod according to standard hospital procedure. Repeat for all implants. OsteoFlap ®

8 Surgical Technique Fig. C Removal of Implant Note: Removal Tool Kit is required for removal. Using the Tab Bending Tool from the Removal Tool Kit, lift up on the anti rotation tab until the tab clears the kerf. Engage the removal tool with the superior plate and turn counter-clockwise to remove superior disk. OsteoFlap ®

9 CLINICAL PHOTOGRAPHS Ordering Information Part NumberDescription 219-001111mm Cranial Flap Fixation Device 219-001717mm Cranial Flap Fixation Device 219-002222mm Cranial Flap Fixation Device 219-0004Cranial Flap Fixation Removal Kit OsteoFlap ®

10 Clinical Articles Reliability of Cranial Flap Fixation Techniques: Comparative Experimental Evaluation of Suturing, Titanium Mini-plates, and a New Rivet-like Titanium Clamp (CranioFix) Neurosurgery, Vol. 44, No. 4, April 1999 Bone Flap Fixation With Titanium Clamps: A New Technique Surgical Neurology, Volume 53, Number 4, April 2000 Cranial Bone Flap Fixation Clamps: Compatibility at MR Imaging Radiology, June 1998 OsteoFlap ®

11 Competitive Product Aesculap CranioFix™ Titanium Clamp System Advantages:  First to market  Sterile packaged Disadvantages:  Requires instrumentation  Holding Forceps  Applying Forceps  Pin Cutter  Removal Forceps  4 steps to fixation  Sterilizing, organizing, storing of instruments.  Finite adjustability Other Information:  Available in 11mm, 16mm & 20mm  Made of Titanium Alloy  Biocompatible  MR-compatible OsteoFlap ®

12 Competitive Product Synthes Flap-Fix™ Cranial Clamp Advantages:  Low profile reduces palpability  Clover leaf design helps provide for adaptation to the curvature of the cranium. Disadvantages:  Requires instrument to cut implant Other Information:  Available in 13mm & 18mm OsteoFlap ®

13 Competitive Product W. Lorenz RapidFLAP™ Advantages:  Sterile packaged Disadvantages:  Requires instrumentation  Applier  Post Cutter  Post Holder  Removal Forceps  4 steps to fixation  Sterilizing, organizing, storing of instruments Other Information:  Available in 12mm, 16mm & 20mm  Made of Titanium Alloy  Also available in Spin Down design OsteoFlap ®

14 Competitive Product Leibinger QuikDisk Cranial Fixation System Advantages:  Unique Grip-n-Zip application  Packaged sterile  Easy removal Disadvantages:  Requires instrumentation  Sterilizing, organizing, storing of instruments Other information:  Available in 14mm & 20mm OsteoFlap ®

15 FOR FURTHER PRODUCT RELATED QUESTIONS, PLEASE CONTACT RAJ SARKAR ( Product Manager- Neuro) AT or CALL (972)677-4735. For all sales related questions please contact your regional sales support representative. OsteoFlap ®

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