A Medical Device Daily

Patients with spinal deformities all know the score when it comes down to treatment of their ailments.

The conditions often take multiple surgeries to correct, and lead to scarring and significant down time for patients. But a California-based med-tech company is looking at a new minimally invasive approach for correcting spinal problems that may make more rigorous treatments look like a thing of the past.

Ellipse Technologies (Irvine, California) is introducing a remote control feature to its Magec (MAGnetic Expansion Control)> system – an adjustment that can non-invasively expand or reverse its length to straighten the human spine. The first application for this technology is for the treatment of spinal scoliosis in children.

The magic of Magec stems from the fact that it requires a single minimally invasive surgical procedure. Once that surgery is completed the patient then has a series of outpatient visits so that the physician can adjust the technology outside of the body with a system's control unit.

The main advantages of the device include spinal motion preservation, no long term permanent implant, minimal trauma and scarring, and finally short hospitalization times. The company reported that thee patients have already received Magec implants with this adjustment feature.

This procedure is a much more attractive to patients the company says – and statistical data seems to support this claim. Currently the standard treatment for scoliosis requires a series of five to ten highly invasive surgical operations with large surgical incisions and long recovery times performed over a number of years – a process so undesirable that 67% of the diagnosed patients refuse the surgical option.

This leaves young children, pre-teenagers and teenagers with spinal scoliosis with few medical options.

Commenting on the procedure Prof. Kenneth Cheung, who helped implant one of the first devices into a patient said, "This first non-invasive adjustment was made in an outpatient setting, just 30 days after the initial implant. The adjustment was completed in less than 30 seconds with the child awake, and was well received by the 5-year-old patient."

The company expects three additional remote control adjustments in January 2010 as part of the Ellipse initial worldwide, multi-center clinical usage study.

In the future Ellipse, hopes to offer corrective therapy to a broader population in need, consisting of both young and older scoliosis patients.

To date the company has yet to receive FDA approval for the device. But it did garner CE mark approval last month (Medical Device Daily, Nov. 19, 2009).

"Ellipse hopes to revolutionize the treatment of scoliosis and offer corrective therapy to a broader population in need, consisting of both young and older scoliosis patients," said Ellipse Chairman Michael Henson in a company statement. "The company is currently enrolling patients in a worldwide, multi-center study and based on our recent CE mark approval, we plan to progress simultaneously with a limited market launch in Europe."

If the device is successful and gains FDA approval then it stands to be at the forefront of a market that includes the Scient'x (Maitland Florida) Isobar Duo Dynamic Stabilization system.

The device received FDA clearance last year (MDD, May 7, 2008) and provides immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, which includes scoliosis.

On the flip side of the coin, a group of Canadian Researchers are developing a brace for scoliosis patients that would prevent spinal curvature from increasing. The smart brace monitors the amount of time patients wear the device and also keeps pressure levels within the desired range in order to prevent spinal curvature from increasing (MDD, June 9, 2008).