Magen Medical Solutions, a developer of anti-adhesion medical devices for orthopedic applications, claimed that it has successfully implanted SpineShield in three patients at a clinical site in Europe.
SpineShield uses Magen’s 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 has 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, said the company.
Gorgan, professor, principal investigator of the clinical study, said: “The SpineShield to dramatically reduce fibrosis adhesion observed in post-operative MRI images. With this it will be able to offer patients a new solution to improve treatment outcome. We are very excited and trust that the SpineShield has the potential to change spine surgery practice.”
Shmuel Beck, CEO of Magen, said: “This is an important day for us, as it recognizes three years of extensive R&D efforts. We anticipate that this initial clinical study and further clinical research will demonstrate the importance of our ground-breaking anti-adhesion device.
“Magen is on track to launch the SpineShield in select EU markets in 2010 and distributors have already been appointed in Turkey, South-Africa, Russia and Israel. The company is developing further product lines based on the same technology for tendon and nerve applications.”