1 / 15

OsteoFlap ® System Overview

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

roddy
Download Presentation

OsteoFlap ® System Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

  2. Market Overview OsteoFlap® • 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

  3. Product Overview OsteoFlap® • 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

  4. OsteoFlap®Features & Benefits

  5. OsteoFlap®Features & Benefits

  6. Surgical Technique OsteoFlap® 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. DRIVER TOOL ANTI-ROTATION TAB

  7. Surgical Technique OsteoFlap® 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. 

  8. Surgical Technique OsteoFlap® 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.

  9. CLINICAL PHOTOGRAPHS OsteoFlap® Ordering Information Part NumberDescription 219-0011 11mm Cranial Flap Fixation Device 219-0017 17mm Cranial Flap Fixation Device 219-0022 22mm Cranial Flap Fixation Device 219-0004 Cranial Flap Fixation Removal Kit

  10. Clinical Articles OsteoFlap® • 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

  11. Competitive ProductAesculapCranioFix™ Titanium Clamp System OsteoFlap® • 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

  12. Competitive ProductSynthesFlap-Fix™ Cranial Clamp OsteoFlap® • 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

  13. Competitive ProductW. LorenzRapidFLAP™ OsteoFlap® • 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

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

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

More Related