On Wednesday, two surgeons in Southern California simultaneously performed a bi-lateral Arthrosurface HemiCAP Shoulder procedure on the same patient. The patient had two posterior traumatic lesions (one on each shoulder) due to a seizure condition. Having two surgeons performing the same surgery, at the same time for the same condition, one operating on the left shoulder while the other operated on the right, is a unique occurrence. The surgery was completed in less than 30 minutes and the patient went home the same day! Arthrosurface is excited to be able to share in such a unique and innovative operation.
In other news, Matthias Schurhoff, VP of Clinical Affairs, recently submitted a paper to the FDA discussing the outcomes of our IDE clinical trial on the focal condyle product. This product was designed to fill large (15 and 20mm) cartilage defects in the femoral condyle for those patients who had failed a previous treatment.
To summarize the study: Forty Patients were treated with the Femoral Condyle HemiCAP. The average age was 47 years (range 31-67). The average body mass index was 27kg/m (range: 19-38). Out of the 40 patients, 38 were treated for defects on the medial femoral condyle (inner knee). The patients followed for a minimum of 2 years and only 1 out of the 40 patients was converted to a joint replacement due to continued disease progression beyond the HemiCAP coverage area.
Achieving such a high success rate in this study with this novel medical device is very satisfying. Overseas many thousands of patients have already received this product over the last 8 years so it is our hope this study will help us to obtain FDA approval for the Femoral Condyle HemiCAP device in the U.S.