The Juvenile Tumour System (JTS), a femoral replacement implant developed by Stanmore Implants, has received US FDA 510(k) approval. The non-invasive extendible distal femoral replacement device may now be used in paediatric orthopaedic oncology surgery in the US. The JTS implant is used to replace large sections of the distal femur that have been removed during surgery, often to treat cancer. It uses an electromagnetic device in order to lengthen the prosthesis without the need for surgery or sedation; previously patients had to undergo multiple, painful surgeries in order to lengthen their implants as they grew. Over 240 of the devices have been implanted in 15 countries worldwide. It costs $267 to undertake a non-invasive lengthening procedure, compared with around $8,000 if surgery is required, Stanmore says. The product will be launched in the US "during the next few months".
US approval for Stanmore's JTS non-invasive extendible implant
The Juvenile Tumour System (JTS), a femoral replacement implant developed by Stanmore Implants, has received US FDA 510(k) approval. The non-invasive extendible distal femoral replacement device may now be used in paediatric orthopaedic oncology surgery in the US. The JTS implant is used to replace large sections of the distal femur that have been removed during surgery, often to treat cancer. It uses an electromagnetic device in order to lengthen the prosthesis without the need for surgery or sedation; previously patients had to undergo multiple, painful surgeries in order to lengthen their implants as they grew. Over 240 of the devices have been implanted in 15 countries worldwide. It costs $267 to undertake a non-invasive lengthening procedure, compared with around $8,000 if surgery is required, Stanmore says. The product will be launched in the US "during the next few months".