A device that uses alternating magnetic fields to treat prosthetic joint infections (PJI) on metallic knee implants has received Breakthrough Device designation from the US Food and Drug Administration (FDA), according to Solenic Medical Inc, its developer, in a media release.
Breakthrough Designation is reserved for devices or technologies that may provide for more effective treatment of life-threatening or irreversibly debilitating conditions in order to give patients timely access.
The patent-pending technology exclusively licensed from University of Texas Southwestern Medical Center offers an approach for the eradication of biofilm on metallic implants with the advantage of being a completely non-invasive treatment of PJI,
“I am pleased with the work of our team that has allowed us to demonstrate our product’s merit and to be recognized as a Breakthrough Device. This designation provides us with priority review and access to designated FDA team members throughout the development and marketing authorization process. This technology meets a significant need for solutions to prosthetic joint infections that risk the mobility of our growing aging population.”
— James Y. Lancaster, CEO of Solenic Medical
Prosthetic joint infections (PJI) is one of the most serious complications in the field of arthroplasty. Currently, treatment of PJI can involve a two-stage revision requiring two additional surgeries and weeks of antibiotic treatment. While it can be effective, the two-stage revision procedure has a high failure rate, poses significant morbidity to high-risk patients, is associated with a negative impact on quality of life, and is very expensive.
A major impediment to effective treatment of PJI is the presence of biofilm, a thin film produced by bacteria that forms a protective shield around the joint and impairs the effectiveness of both antibiotics and the immune system. The inability to eradicate biofilm is the primary reason that surgical replacement of an implant remains the standard of care for the treatment of PJI, the release explains.
[Source(s): Solenic Medical Inc, PRWeb]
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