Biomet Unveils Single-Use Anterior Cervical Plating System at NASS

Officials with Biomet Spine LLC, a subsidiary of Biomet Inc., reported the first surgery employing the company’s single-use MaxAn One, an anterior cervical plating system designed to minimize the chance of infection and reduce hospital and ambulatory surgery center (ASC) costs. The surgery was successfully conducted at Crittenton Hospital Medical Center in Rochester Hills, Mich.

The company received U.S. Food and Drug Administration 510(k) clearance for the system on Nov. 5.

The MaxAn One is a system of sterile-packed implants and disposable instrument kits. According to Biomet, sterile-packed system provides the potential for reduced product contamination and lowered risk of infection, while eliminating the need for labor-intensive hospital staff activities such as preoperative sterilization, post-operative cleaning, decontamination, product handling, replenishment, and the return and/or replacement of standard, reusable instruments.

The cost of the system is expected to be comparable to other anterior cervical plate systems, and the single-use aspect “has the potential to have a positive, direct impact on a facility’s overall profitability,” officials said.

The MaxAn One Anterior cervical system delivers the same clinical results as the company’s widely used MaxAn Green cervical plate, which is designed to help reduce the incidence of adjacent level ossification.

John LaMacchia, M.D., the physician who conducted the first with the system said: “The MaxAn One anterior cervical system is truly unique in that it provides a sterile, disposable instrument set that is brand new, lightweight, compact, and user-friendly for every surgery. This will be especially beneficial when I have multiple anterior cervical fusions on the same day because we’ll be able to avoid delays due to processing and re-sterilization. The system will also benefit hospitals and ASCs by providing much improved traceability of implants and instruments, reducing the storage space required, and dramatically reducing the logistical steps required with traditional, reusable implant and instrument sets.”

LaMacchia is secretary in the Department of Surgery at Crittenton Hospital Medical Center, co-founder and vice president of DeClaire LaMacchia Orthopaedic Institute and an assistant professor at Wayne State University School of Medicine.

“The MaxAn One anterior cervical system has the potential to dramatically enhance efficiencies throughout the treatment paradigm,” said Jim Cloar, general manager of Global Spine at Biomet. “Because it is single use, the MaxAn One anterior cervical system has the potential to improve staff productivity and reduced overall processing costs—closely monitored metrics at many hospitals and ASCs that directly impacts a center’s overall profitability. The surgeon is guaranteed a new set for each surgery. Equally important are the possible savings due to potentially reducing post-op infections, which can result in costly re-operations that may not be reimbursed by insurers. MaxAn One is designed to avoid these costly procedures.”

MaxAn One features the MaxAn Green anterior cervical plate, which was designed by surgeonscAlan S. Hilibrand, M.D.; K. Daniel Riew, M.D.; and Jeffrey C. Wang, M.D. The system’s unique plate design, according to the company, allows for wide screw angulation, permitting the use of a shorter plate and thus may help prevent impingement and reduce the risk of ossification of the adjacent level.

The new disposable system will be highlighted at the 2014 North American Spine Society (NASS) meeting being held Nov. 12-15 in San Francisco, Calif., at the Biomet booth #1429.