NICE recommends further research on imaging system

by emma 7. November 2011 10:17

EOS 2D 3D imaging system

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

A new approach to spinal fusion surgery

by emma 4. November 2011 16:12

Medtech Product News

US-based Medtronic Spinal has launched a new type of spinal fusion surgery.

The MAST MIDLF procedure, announced to the North American Spine Society in Chicago, enables minimally invasive spinal fusion.

Described as a midline laminectomy, the procedure accesses the spine in the middle lower back, removing the need for the surgeon to work through a tubular retractor.

Over 250,000 people in the US undergo spinal fusions each year to treat degeneration of the lumbar spine.

“This surgical strategy enables a highly efficient, minimally invasive lumbar fusion, while allowing visualisation of familiar posterior landmarks,” said Dr. Richard Hynes, spine surgeon at The B.A.C.K. Center in Melbourne, Florida.

“A midline approach offers surgeons a number of benefits in addressing the challenges associated with decompression as well as sacral fixation in the lumbar or lower spine.”

The MAST MIDLFTM procedure can be used with Medtronic’s surgical navigation and imaging systems, improving the accuracy of device placement and reducing clinician exposure to radiation.

The new surgical procedure is the latest addition to Medtronic Spinal’s minimally invasive MAST portfolio of surgical treatments for degenerative and deformity-based spinal conditions.

Medtronic's spinal business, based in Tennessee, is a global leader in the treatment of spinal conditions.

FDA approves two spine devices

by emma 31. October 2011 12:09

Spinal USA S-Lok PC Posterior Cervical System

The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).

Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.

The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.

He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.

Spinal USA VAULT Stand Alone Alif System DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.

Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.

Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.

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