Magen Medical Solutions announces successful implantation of SpineShield anti-adhesion device

Apr 19 2010

Magen Medical Solutions Ltd., a medical device company developing unique anti-adhesion devices for orthopedic applications, is pleased to announce that it has successfully implanted its first product, the SpineShield, in three patients at a clinical site in Europe.

“we are very excited and trust that the SpineShield has the potential to change spine surgery practice.”

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. Magen's flagship device, the SpineShield, uses Magen's proprietary technology to prevent fibrotic adhesion of the scar to the dura and the nerve root and to reduce related pain and complication risks. The SpineShield is a metal device that physically separates the scar from the delicate spine structures. After healing, the SpineShield is removed during a short minimal invasive out-patient procedure.

Magen initiated its first-in-human, single-center, prospective feasibility study to assess the initial safety and efficacy of the SpineShield implantation for the prevention of epidural scar fibrosis following hemilaminectomy. The study is being held in the Neurosurgery Department of the Bagdasar Arseni Emergency Hospital, Bucharest, Romania. To date, three SpineShield devices have been successfully implanted and removed from three patients. The removal procedure was performed through a minimal invasive 1cm incision. According to initial feedback from patients and physicians, the removal procedure was painless, easy, and took a few minutes only. No complications were reported. An additional seven patients will be enrolled in the study.

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." Prof. Gorgan adds that "we are very excited and trust that the SpineShield has the potential to change spine surgery practice."

"This is an important day for us, as it recognizes three years of extensive R&D efforts," says Dr. Shmuel Beck, Magen's CEO. "We anticipate that this initial clinical study and further clinical research will demonstrate the importance of our ground-breaking anti-adhesion device."

Dr. Beck adds that "Magen is on track to launch the SpineShield in select EU markets in 2010" and that "distributors have already been appointed in Turkey, South-Africa, Russia and Israel." In addition, "the company is developing further product lines based on the same technology for tendon and nerve applications."