Paradigm Spine Receives CE Mark For DSS Dynamic Spine Stabilization System

Spine Stabilization System

Paradigm Spine announced that it has received a European Union CE Mark for its DSS implantable dynamic spine stabilization system.

The CE Mark will allow the company to begin marketing the DSS system in Europe and many other countries that recognize the certification.

The first surgery involving the DSS system was performed on April 27th, 2007 in Straubing, Germany by Dr. Rudolf Bertagnoli.

The DSS system is a pedicle-screw based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.

The system was developed over a two-year period in close cooperation with Professor Hans-Joachim Wilke, a world-renowned Professor of Biomechanics from the University of Ulm in Germany, and Dr. Bertagnoli, the most experienced spine arthroplasty surgeon worldwide.

The modularity of the DSS system enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system.

The DSS dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size DSS dynamic coupler, the posterior segmental height can also be adjusted. The DSS fusion coupler provides rigid segmental fixation utilizing the same instrument set. One of the features and benefits of the system is the use of percutaneous screw positioning that facilitates a minimally invasive muscle- sparing approach.

Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, "The DSS system is the product of collaborative thinking between two of the world's most experienced spine motion-preserving experts, from both a scientific and clinical point-of-view."

"The DSS system is one of the first truly dynamic stabilization systems because it increases segmental stiffness while controlling specific ranges of motion as the patient goes about his or her daily activities," he noted. "We are particularly excited to have benefited from the enthusiastic development efforts and significant contributions of Professor Wilke and Dr. Bertagnoli."

Professor Wilke said, "I worked very closely with the Company on incorporating the key strategic and scientific elements of the ranges and types of motion which need to be controlled by a true dynamic stabilization system. Specifically, we designed the system to focus on controlling 'active zone' motions, which are normally associated with pathologic painful arcs of motion."

Professor Wilke further added, "This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment."

Dr. Bertagnoli said, "The surgery on Friday [April 27] went very well and I believe the DSS system has the potential to become an important new option in the continuum of spine care. Having used most of the major spine arthroplasty products I, like Professor Wilke, am convinced of the uniqueness and potential impact of the DSS system for the treatment of my patients."

The DSS system is Paradigm Spine's fourth product to receive a CE Mark, following the coflex(R) interspinous implant, the DCI dynamic cervical implant, which received the CE Mark on December 5, 2006; and the coflex-F implant system which received the CE Mark on December 15, 2006.