US-based commercial stage device firm IlluminOss Medical has enrolled the first patient in its EU Light Fix trial to treat impending and pathologic fractures in the humerus due to metastatic carcinoma.
The company noted that the first patient enrolled in the EU Light Fix trial is a female with metastatic cancer of the left humerus.
Approximately 45 patients at ten centres in Austria, Germany and the Netherlands will be enrolled in the trial, which will be led by Vienna General Hospital (AKH) orthopaedic oncologist and head of the Department of Orthopaedic Surgery Dr Reinhard Windhager.
The company uses its bone stabilisation technology, the IlluminOss System, to design, develop and market orthopaedic fracture repair products.
The IlluminOss System, which uses a light-curable polymer contained within an expandable balloon catheter to achieve bone stabilisation, allows for fracture fixation through patient-specific intramedullary implants.
The simple, percutaneous surgical approach allows surgeons to create a patient-conforming implant. In many cases it allows the patient to get back to daily activities more quickly without the hindrance of a hard cast, the company noted.
Dr Windhager said: "The IlluminOss System will potentially allow orthopaedic surgeons to approach impending and actual fractures resulting from metastatic malignancy in a groundbreaking way that will benefit both the surgeon and the patient.
"I am pleased to lead the first Light Fix trial in the EU and hope our efforts will help validate an approach to orthopaedic surgery that can provide treatment options for patients that previously had little or no recourse, and also potentially lessen complications and improve outcomes."
Benefits observed in patients who used this product include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates.
The company said that once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.