LDR Obtains Approval In Japan For Their Easyspine(R) Posterior Osteosynthesis System

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 May 2009 - 1:00 PDT

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LDR, a total spine solution company, announced they obtained approval in Japan to market their Easyspine posterior osteosynthesis system. The Easyspine system was approved by the Ministry of Health, Labor and Welfare on March 9, followed by government approval for reimbursement on April 1. LDR has worked closely with the Yufu Itonaga Company in Tokyo to obtain this approval. The Yufu Itonaga Company will distribute and support the Easyspine line.

Kaoru Sakamoto, President and CEO of Yufu Itonaga comments, "We have been working very diligently and closely with LDR for almost 3 years to achieve this important milestone. We are proud to be the first in Japan to obtain approval to market a spine system that is delivered sterile to the customer, a very important benefit of the Easyspine system. We have a very strong organization that is prepared and eager to serve our Japanese surgeon customers."

Developed in France by LDR Médical with strong surgeon involvement, Easyspine has been used successfully in thousands of procedures to date worldwide. Its unique patent-pending pedicle screw design, with integrated multi-axial capability, provides flat-on-flat screw to rod purchase, and can achieve a variety of rigidities by accommodating rods of different thicknesses. This design approach provides many technical advantages and creates a system that offers the surgeon increased intra-operative flexibility while only using one-third the inventory levels of conventional fusion systems. Additionally, all LDR implant products are delivered to the hospital individually packaged, labeled and sterilized, thereby reducing sterility concerns and improving product traceability - a feature no other spine company currently offers.

Christophe Lavigne, CEO of LDR adds, "The benefit of being able to offer a system that is delivered sterile gives us a strong advantage over other companies. We are very confident that the Yufu Itonaga Company will be hugely successful in marketing this system in Japan and our organization is ready to dedicate the financial and human resources needed to be successful in this critical market in Asia. This reinforces our strong position in the Asian market and our strategy as an international global spine company."

Source
LDR

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