Solenic Medical received FDA approval of its investigational device exemption application, allowing the company to launch a pivotal clinical trial of its Sola-2 alternating magnetic field system for patients with periprosthetic joint infections.
The study will evaluate the safety and effectiveness of the technology in patients with infected knee replacements and is intended to support future FDA marketing authorization, according to a June 23 news release.
The system is designed to noninvasively target bacterial biofilm on infected orthopedic implants by heating the outer surface of metallic implants. The technology could become the first noninvasive treatment designed to help eradicate biofilm on infected orthopedic implants.
Periprosthetic joint infections are among the most costly complications in orthopedics, with hip, knee and shoulder infections generating an estimated global healthcare cost burden of more than $6 billion annually. That figure is projected to exceed $15 billion per year by 2035, according to the release.
The FDA-authorized trial follows an early feasibility study involving adults with knee implant infections undergoing debridement, antibiotics and implant retention.The study found the device performed as intended and reported no device-related adverse events.
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