Kinamed Issued Japanese Regulatory Clearance

Kinamed has been granted regulatory clearance for its SuperCable Iso-elastic Polymer Cerclage System by the Japanese Ministry of Health, Labour and Welfare.

Already used in a number of orthopedic reconstructive and trauma procedures in the United States, the clearance will allow the company to begin SuperCable commercialization in Japan through distribution partner Yufu Itonaga Co. Ltd. of Tokyo.

Yufu also represents two other Kinamed product lines in Japan: the CarboJet CO2 Lavage System used for cleaning and drying the bone bed in cemented arthroplasty procedures and the NeuroPro Cranial Fixation System used by neurosurgeons for cranial closure. The company’s portfolio also includes associated cable-plates and trochanteric grips for the cerclage cables; the KineMatch Patello-Femoral Replacement, a CT based custom arthroplasty technology; the NaviPro Surgical Navigation System, and the NeuroPro Cranial Plating System.

Touted by Kinamed as the only iso-elastic polymer cerclage system in the world, the SuperCable system was designed to help reduce metal particle generation due to metal-on-metal wear, as well as to provide heightened strength and elasticity. Constructed from high-strength polyethylene fibers and nylon, and fixed with a titanium clasp, immunogenic metals such as chromium and cobalt are avoided. The pliable polymer fibers offer extraordinary fatigue strength and resistance to abrasion. The “Iso-Elastic” nature of the SuperCable is designed to allow it to move with the bone during cyclic loading in order to help prevent “digging in” and to remain tight during the bone healing phase.

“We are very appreciative of our very longstanding relationship with Yufu Itonaga and particularly for the work they have done in obtaining the Japanese regulatory approval for SuperCable,” Kinamed president, Vineet Sarin, Ph.D., said in a company news release. “Commercializing SuperCable into the Japanese orthopedic market is a major milestone for Kinamed.”

Traditional metal cerclage cables are made up of many tiny braided metal wire filaments that, by the very nature of their construction, result in a large number of metal-on-metal wear interfaces. Wear between nonbearing surfaces can occur at modular connections, at interfaces between the prosthesis and cement or bone, and with ancillary devices employed to reattach the trochanter or to stabilize periprosthetic fractures or bone grafts. There have been reports of loose and broken stainless steel hardware in patients due to this “fretting wear.”

In a 2004 study by Urban, et al. in the Journal of Arthroplasty, metallic particles generated between nonbearing surfaces were present in the liver and/or spleen of 73 percent of patients with a prior failure and revision of their hip arthroplasty.

“I am very pleased that our company can now offer such a unique and innovative cerclage system to the Japanese orthopedic community,” Hironori Sagawa, Yufu Itonaga surgitec division director, said. “It is exciting to be able to offer a product that has such significant clinical benefits versus older technologies and that also offers important synergies in our product portfolio.”