Stanmore Receives US FDA Approval for its JTS Non-invasive Extendible Implant
LONDON, June 24, 2011 /PRNewswire/ --
Stanmore Implants ("Stanmore"), specialists in the design and manufacture of patient specific implants for complex orthopaedic reconstructions, announces that it has received US FDA 510k approval for its Juvenile Tumour System ("JTS") non-invasive extendible distal femoral replacement ("JTS implant"), for use in paediatric orthopaedic oncology surgery.
The JTS implant is used to replace large sections of the distal femur (thigh bone) that has been removed during surgery, often to treat cancer. Previously patients had to undergo multiple, painful surgeries in order to lengthen their implants as they grew. The JTS implant uses an electromagnetic device in order to lengthen the prosthesis without the need for surgery, anaesthesia or sedation, thus reducing the risk of complications.
In November 2002 the first patient, a 13-year-old girl received the JTS non-invasive extendible implant in the UK. Today she has reached skeletal maturity with legs of equal length. Since then over 240 devices have been implanted at specialist centres in 15 countries worldwide. Each implant is designed and manufactured specifically for the recipient patient by the team at Stanmore.
The JTS implant also has significant health economic benefits. A recent US study identified that it costs US$267 to undertake a non-invasive lengthening procedure compared to approximately US$8,000 if surgery is required. Lengthening procedures are undertaken regularly and can be undertaken in doctors' surgeries or outpatient departments.
Brian Steer, Executive Chairman of Stanmore, said:
"Gaining approval in the key US market is a major achievement for Stanmore. Having used the product for nine years in the European markets we are absolutely confident of the product's ability to significantly improve patient outcomes and quality of life by negating the need for repeated surgery in children. This has very