Successful Completion of First Surgery Following Official U.S. Market Launch in March
Cizimedtec, a company specializing in the research and manufacturing of orthopedic implants, announced on the 23rd that its spinal fixation device, the Innover Spinal System, has not only received approval from the U.S. Food and Drug Administration (FDA), but was also recently successfully used in its first surgery at a U.S. hospital.
Innover received official sales approval, known as 510(k), from the U.S. Food and Drug Administration (FDA) in February of last year. The 510(k) is a mandatory clearance process for selling medical devices in the United States, which requires proof that the product is substantially equivalent in terms of safety and effectiveness to an already marketed device. This is particularly significant as it allows entry into the U.S. market, which is known for its high barriers to entry in the global medical device industry.
The notable aspect of this approval is that, for the first time among domestic manufacturers, Innover has been officially approved by the FDA as a spinal fixation system compatible with the StealthStation™, a representative spinal surgery navigation system from the U.S. company Medtronic. Its interoperability with this system was demonstrated and recognized by the FDA.
Following this, the product was officially launched in the U.S. market in March of this year, and the first surgery using Innover was recently performed successfully at Memorial Hermann Surgical Hospital in Texas, United States. The operation was performed by Dr. Steven J. Cyr, who is board-certified in both orthopedic and plastic surgery, and involved spinal fixation surgery at three lower back segments (L3 to S1).
Dr. Steven J. Cyr, who performed the surgery, stated, "It was an honor to be able to use the Innover Spinal System in conjunction with the StealthStation navigation system during a multi-level spinal fusion procedure. Its intuitive interface, advanced navigation features, state-of-the-art instruments, and the dual-lead-thread pedicle screw significantly improved the efficiency and safety of screw insertion. I look forward to continuously utilizing the Innover Spinal System to further optimize spinal fixation procedures and enhance both treatment outcomes and patient safety."
The core technology of the product is the 'Corticocancellous thread form'. Since bone density differs between cortical bone and cancellous bone, two types of threads suitable for each bone type have been applied to a single screw. The screw is designed to precisely penetrate the hard cortical bone and anchor deeply into the softer cancellous bone, allowing for quick, natural insertion while ensuring firm fixation. This helps reduce surgery time and increases the stability of the surgical site.
Additionally, a friction head structure was applied to ensure that the metal rod (Rod) remains firmly fixed during surgery and does not wobble or become misaligned. This structure enables the surgeon to easily secure the rod in the correct position and ensures it remains stable afterward. Furthermore, the system is compatible with rods made from various metals, including titanium alloy and cobalt-chromium alloy, in both 5.5mm and 6.0mm diameters, allowing medical staff to flexibly select rods according to the surgical method or patient condition.
Yoo Hyunseung, CEO of Cizimedtec, stated, "Innover is not just a new product, but an integrated spinal surgery solution that embodies Cizimedtec's technological expertise and clinical experience. In particular, interoperability with spinal surgery navigation systems enables precise and stable high-difficulty procedures, which serves as a key competitive advantage for entering advanced medical markets such as the United States. Cizimedtec plans to sequentially supply Innover to major hospitals in North America and accelerate its global market expansion."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
