Solenic Medical announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The noninvasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a prosthetic joint infection (PJI).
The Solenic AMF treatment was performed in collaboration with the patient’s care team. No device-related adverse events have been reported to date, and ongoing patient monitoring has indicated that the treatment has progressed positively. This case follows the completion of enrollment in Solenic’s human feasibility safety study with collected patient follow-up ranging from six weeks to three months. Again, no device-related adverse events have been reported to date from that study.
FDA’s authorization was specific to this single patient and is not indicative of broader approval or availability. The Solenic AMF technology (Sola2 AMF Knee System) is an investigational device and has not received FDA marketing authorization for commercial use.
“We are highly encouraged to see the continued progress in the compassionate use patient’s recovery,” said Bart Bandy, Solenic Medical CEO. “We are committed to addressing this un-met need and bring to market an effective, non-invasive new standard of care for patients with this challenging condition, recognizing that global joint replacement procedures are projected to grow at a record pace over the next five years.”
Solenic Medical announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The noninvasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a prosthetic joint infection (PJI).
The Solenic AMF treatment was performed...
Solenic Medical announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The noninvasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a prosthetic joint infection (PJI).
The Solenic AMF treatment was performed in collaboration with the patient’s care team. No device-related adverse events have been reported to date, and ongoing patient monitoring has indicated that the treatment has progressed positively. This case follows the completion of enrollment in Solenic’s human feasibility safety study with collected patient follow-up ranging from six weeks to three months. Again, no device-related adverse events have been reported to date from that study.
FDA’s authorization was specific to this single patient and is not indicative of broader approval or availability. The Solenic AMF technology (Sola2 AMF Knee System) is an investigational device and has not received FDA marketing authorization for commercial use.
“We are highly encouraged to see the continued progress in the compassionate use patient’s recovery,” said Bart Bandy, Solenic Medical CEO. “We are committed to addressing this un-met need and bring to market an effective, non-invasive new standard of care for patients with this challenging condition, recognizing that global joint replacement procedures are projected to grow at a record pace over the next five years.”
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