TSpaceXP Interbody System (Credit: PR Newswire)
Aesculap Implant Systems, LLC, a medical device company, announced a new warranty program on its established portfolio of surface-enhanced interbodies for spinal fusion.
This warranty announcement coincides with the launch of the TSpace interbody system, treated with Plasmapore surface enhancing technology. The warranty offers participating facilities a device replacement in the instance of a reoperation because of clinically-relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician’s ability to visualize adjacent anatomy.
This is the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry warranting against both delamination of a surface enhancement and the ability to visualize an implant without artifact.
This new Aesculap warranty on Plasmapore devices differentiates the technology from other manufacturers who have less widely studied surface coated or otherwise enhanced spinal fusion interbodies. The current U.S. spine market favors PEEK, a medical grade plastic, for fusion. However, PEEK alone may lack the biocompatible characteristics necessary to stimulate a lasting fusion. For this reason, some spinal implant manufacturers are going back to all titanium implants; however, this structural material may create intraoperative and postoperative visualization issues which may jeopardize the safety profile for patients.
Aesculap began developing its expertise in surface enhancements with its BiContact Universal Hip System in 1986 and was first to the U.S. spine device market with surface-enhanced PEEK-OPTIMA interbodies for spinal fusion applications. Aesculap’s experience, with more than 20,000 Plasmapore devices implanted to date plus results from over 20 clinical studies, provided the foundation to offer the device warranty.
According to Chuck DiNardo, President of Aesculap Implant Systems, LLC, “In the consumer market, if a product does not meet expectations, the purchaser expects a money-back type of guarantee. This has not been the norm in the device market. We created a program to demonstrate to healthcare providers that we believe in our product, our clinical data and our long-standing experience and ultimately share their goal of a lasting treatment for their patients’ chronic back issues.”
As a forerunner in surface enhancing technology, Aesculap’s proprietary process applies a pure titanium surface that is porous, osteoconductive and biocompatible to the core of each Plasmapore implant on the top, bottom and lateral surfaces. Based on the global success of this surface enhancing technology, Aesculap has developed a full portfolio of Plasmapore devices like the newest TSpace interbody to address a variety of degenerative spinal indications and approaches.
