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X-BOLT Orthopaedics receives CE Mark certification for X-Bolt®

Wednesday, 14 September 2011

Hip fracture fixation device to commence clinical trials in Irish Hospitals from September

X-BOLT Orthopaedics, a Dublin based medical device company today announced that its X-Bolt® device has received CE Mark certification from BSI (British Standards Institute), in accordance with the European Medical Device Directive.
The medical device company (www.x-bolt.com) also announced the commencement of an ethics-approved clinical trial for the X-Bolt® device in both Limerick and Waterford hospitals.

Commenting on the developments, Dr. Brian Thornes, Founder and Chief Executive of X-BOLT Orthopaedics said, “These announcements, in addition to the recently granted European Patent on the X-Bolt® device are important milestones in the company’s development and ensures that the X-Bolt® remains on schedule for release to the UK and European market in the last quarter of 2011.”

Established in 2008, X-BOLT Orthopaedics develops innovative orthopaedic medical devices to facilitate surgery and improve outcomes for trauma and orthopaedic patients.

The X-Bolt® is a novel expanding bolt device that gives significantly better fixation in osteoporotic hip fractures. An aging population combined with osteoporosis has resulted in a growth of hip fracture cases by approximately 5% per annum.

Explaining the complexities for hip fracture injuries, Mr. Niall Hogan FRCSI (Orth), consultant orthopaedic surgeon in Dublin said, “Hip fracture patients are by their nature usually very frail. A high proportion of our acute hospital bed occupancy is taken up with hip fracture patients due to their co-morbidities. This cohort of patients, generally have a longer average bed stay, adding to a greater overall healthcare cost. Complications are not well tolerated by this group of patients. Bone strength and quality is also relatively poor in the elderly due to osteoporosis, which may affect quality of the fixation that in turn may delay mobilisation and discharge from the acute hospital.”

Explaining the benefits of the X-Bolt® for hip fracture injuries, Dr. Brian Thornes outlined, “Hip screw ‘cut-out’ is the single major mechanical complication of surgery, approximately 4% of cases. Care costs multiply considerably with any complication in elderly patients. The X-Bolt® specifically addresses these problems, comprehensive hip plating and hip nailing systems with the X-Bolt® common to both have been designed and biomechanically tested. Worldwide US$1Bn could be saved by significantly reducing cut-out complications or domestically this would translate into a €4M saving in Ireland.”

The X-Bolt® device will be exhibited at the combined British and Irish Orthopaedic Associations annual meeting, in the Dublin Convention Centre from the 14th to 16th of September.

Please view video descriptions on the X-Bolt http://www.x-bolt.com/
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