Simplify Medical, Inc., a pioneer in the field of disc arthroplasty with a non-metal artificial cervical disc MRI compatible, has received a CE mark for its Simplify Disc. The CE Mark allows the marketing and commercialization in the European Union and other countries that accept the CE Mark. The ISO13485 certification was obtained in 2008.

Simplify Disc is a replacement for cervical disc composed of MRI compatible materials designed to eliminate invasive CT scans, reduce exposure to radiation, and offer an option to patients without metal. Simplify Disc includes endplates designed to better adapt to the vertebral body under a common load to the cervical spine and offers disc heights as small as 4 mm for the anatomy of smaller patients.

"The CE mark is a significant achievement for Simplify Medical, as it allows us to market our Simplify Disc internationally and expand our extensive clinical experience on which this approval was based," said David Hovda , CEO of Medical Simplify . "Since we use MRI compatible materials using ceramics and advanced medical polymers, we can offer a solution without metal surgeons and patients. MRI imaging is the most accurate option to evaluate the soft tissue of the spine, is non-invasive for patients, and avoids ionizing radiation and contrast injections associated with CT scans/BMA ".   

Simplify Disc allows a range of motion similar to that of natural intact disc, while providing reduced disc heights for treating smaller patients, as well as a streamlined implantation procedure. Simplify Medical plans to begin a clinical trial of an investigational device exemption (IDE) in the United States in 2015, utilizing clinical and considerable experience in the preservation movement.   

Simplify The Disc is MRI compatible artificial disc made of materials without harmful effects on MRI-based ceramics and advanced polymers eliminating the need to perform CT scans/BMA intensive radiation. PEEK-on-ceramic articulation is designed for low wear levels in order to maximize the long-term sustainability and Simplify Disc offers low rise implants for patients with spaces between the cervical discs are smaller and for which larger implants are not suitable.  

Simplify Medical Society specializes in disc replacement of the cervical spine and uses innovative MRI compatible materials designed to reduce the need for ionizing radiation and to provide better options for patients.