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Aesculap Launches Warranty for Plasmapore XP Devices

Posted in Views on the News | Apr 2017 | Comments (0)

Tags: Editor's Choiceorthopaedic implantpeekrisk management practicesspine

Aesculap Implant Systems established a warranty program for Plasmapore®XP-coated spinal interbody fusion devices. 

In the instance of re-operation due to clinically-relevant delamination, or if impaction debris or a CT or MRI artifact caused by the device interferes with the visualization of adjacent anatomy, the warranty offers a device replacement.

This is the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry to warrant against delamination of a surface enhancement and the ability to visualize an implant without artifact.

Aesculap’s proprietary coating process applies a porous, osteoconductive and biocompatible titanium surface to each implant on the top, bottom and lateral surfaces. Results from ovine study suggest that PlasmaporeXP-coated PEEK interbody implants have significantly greater pullout strength and bony ingrowth than uncoated implants at 12 and 24 weeks.

Earlier this year, SI-BONE enacted a warranty program for the iFuse Implant System®, indicated for fusion for certain disorders of the sacroiliac joint.

The iFuse warranty focuses on procedure-related outcomes and positive patient results. Terms provide users with a free iFuse Implant™ to either supplement or replace previously-placed iFuse Implants within a one-year period following the initial or index procedure, if revision is required.

Further, for any revision that occurs within the one-year warranty period that does not require a supplemental or replacement iFuse Implant, the warranty provides a one-time credit towards an iFuse Implant for use in a future iFuse Procedure™.

Smaller spine companies have begun offering warranties in recent years in order to remain competitive. They include:

  • Medicrea for patient-specific UNiD thoracolumbar and cervical rods 
  • Spinal Elements for Ti-Bond-coated cervical interbody devices  
  • Titan Spine for Endoskeleton interbody fusion devices

What is your opinion on warranties for orthopaedic implants? Share your thoughts in the comment box.

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