Press Release: US FDA approval JTS non-invasive extendible implant
Stanmore receives US FDA approval for its JTS non-invasive extendible implant
25 June 2011 -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 products ability to significantly improve patient outcomes and quality of life by negating the need for repeated surgery in children. This has very clear health economic repercussions and as such we look forward to introducing this product in the United States during the next few months.
Stanmore is now focussed on introducing this product across the US and is in the process of assembling a specialist sales team to market the product to orthopaedic oncology surgeons.
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Notes to Editors
Stanmore Implants Worldwide
Stanmore Implants Worldwide is an innovative orthopaedic business focused on the design and manufacture of both bespoke and modular implants for limb sparing and complex primary and revision joint replacement.
Stanmore designs, manufactures and markets a custom implant service alongside a portfolio of orthopaedic implants for limb salvage and complex joint replacement, and is known for creating some of the worlds most successful implants.
Stanmore acquired its robotic bone preparation technology through the acquisition of Acrobot, a medical devices company specialising in computer assisted orthopaedic surgery in August 2010.