New Ovine Study Concludes that Plasmapore®XP Coated Interbody Devices Possess Biomechanical Advantages and Increased Bone Formation Over Uncoated PEEK Implants

Aesculap Implant Systems, LLC announces results of a PlasmaporeXP ovine study that analyzes biomechanical pullout strength and histology of PlasmaporeXP coated implants over time.

Center Valley, PA (February 12, 2014) – Aesculap Implant Systems, LLC is pleased to announce its participation in an ovine study focused on the advantages of using PlasmaporeXP coated PEEK interbody implants. The study states that PlasmaporeXP coated implants have significantly greater pullout strength and bony ingrowth than uncoated implants at 12 and 24 weeks. It also concludes that the PlasmaporeXP coating presents a biomechanical advantage by providing initial stabilization as well as long term advanced stability.  

The objective of the study, authored by Boyle C. Cheng, PhD and published by Aesculap Implant Systems, LLC in January 2014, was to substantiate the use of the PlasmaporeXP coating on interbody devices and explore whether the coating increases implant stability over time.

The PlasmaporeXP Multi Time Point Survival Study investigates the comparative osseointegration pullout strength from ovine bone samples of two types of PEEK dowels. One treatment involves uncoated PEEK dowels and the other treatment involves PlasmaporeXP coated PEEK dowels.  The study measures pullout strength and histological results at the initial implantation,  12, and 24 week survival time points. Key study findings:

  • Biomechanical pullout strength for PlasmaporeXP coated dowels is significantly greater than the uncoated dowels at both 12 and 24 weeks (p<0.001). This demonstrated that osseointegration occurs over time with the PlasmaporeXP coated dowels.  No significant increase in pullout strength over time was detected for the uncoated group.
  • PlasmaporeXP coated dowels show over 40% more bony apposition at 12 weeks and  significant new bone formation at 24 weeks compared to the uncoated dowels.
  • Significantly less inflammation and fibrosis is detected for the PlasmaporeXP coated dowels compared to the uncoated dowels.

Dr. Cheng explains that, “the clinical relevance of this study should instill both the patient and surgeon with confidence in the stability of Aesculap’s PlasmaporeXP coated devices from implantation to fusion. Due to the optimized surface coating, the device supports excellent interbody fit and also long term bony apposition. It is clear that the PlasmaporeXP coating provides good initial stability with superior long term results.”

"These exciting results not only support our mission to improve the quality of a patient’s life, but represent a cornerstone for the future of spinal fusion treatment,” stated Chuck DiNardo, President of Aesculap Implant Systems, LLC.

About PlasmaporeXP
PlasmaporeXP is an innovative surface enhancing technology designed to complement the PEEK interbody implant. The roughened surface provided by PlasmaporeXP, a porous pure Titanium and osteoconductive surface coating, increases the migration resistance and mechanical strength of PEEK interbody implants. PlasmaporeXP maximizes the contact area between the implant and vertebral endplate, offering surgeons the ideal scaffold for a stable fusion. www.aesculapimplantsystems.com/plasmaporexp

About Boyle C. Cheng, PhD
Dr. Cheng is a nationally-recognized Neuroscientist and current Director of the Neurosurgery Spine & Biomechanics Research Laboratory at Allegheny General Hospital in Pittsburgh, PA. Dr. Cheng also serves as an Adjunct Assistant Professor in the Department of Bioengineering at Carnegie Mellon University, and Associate Professor in the Department of Neurosurgery at Drexel University School of Medicine. 

Contact: 
Dana Burns, Corporate Communications
Aesculap Implant Systems, LLC
office: 610-984-9242
toll-free: 800-258-1946, x5242
cell: 610-217-4964
email: dana.burns@aesculapusa.com

 
 

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