Magen Medical Solutions of Ramat-Gan, Israel has reported the successful implantation of its anti-adhesion SpineShield, a metal device that prevents epidural scar fibrosis following a hemi-laminectomy, in three patients in its first-in-human, single-center, prospective feasibility study.
From the product pages:
The SpineShield is a flexible spiral foil, reinforced by a metal core wire. The foil is made from biocompatible material. It will come in a range of sizes. While in place, the spiral lies flat, with the coils partially overlapping, to form a surface which adapts to fit the surface area. The overlapping faces are rough, to increase friction between them and to ensure that the spiral does not unravel under the pressure of the surrounding tissues.
From the press release:
Post-operative adhesion is considered a major cause of failed back surgery. In up to 15% of cases, patients suffer from pain due to spinal adhesion, or scar tissue formation around the spinal cord, which may require a second surgery for correction. The SpineShield physically separates the scar from the delicate spine structures, preventing fibrotic adhesion of the scar to the dura and the nerve root. A fibrotic scar can cause compression and tethering of the spinal cord or nerve roots, resulting in post-operative pain and physical impairment. After healing, the SpineShield is removed during a short, minimally-invasive out-patient procedure.
Prof. Gorgan, principal investigator of the clinical study, expects “the SpineShield to dramatically reduce fibrosis adhesion observed in post-operative MRI images” and believes that “he will be able to offer his patients a new solution to improve treatment outcome.”
An additional seven patients will be enrolled in the study. SpineShield is CE Marked and pending FDA approval.
Press release: Magen Medical Solutions: First Worldwide Patients Treated with Anti-Adhesion SpineShield…
Product page: SpineShield…