Disposable Spine Implant System Gains FDA Approval

Disposable Spine Surgery Kit

ECA Medical’s new disposable surgical instrument kit for spine surgeries is the first product of its kind to be approved by the FDA. According to the company spokesperson, the kits are expected to be available for purchase no later than the beginning of the second quarter of the 2015 fiscal year.

The fixation instruments will come packaged in a sterile-packed tray that is designed for single use and will include fixed drivers, ratchets and cannulated torque-limiters. It is designed to complement the Intelligent Implant Systems (IIS) Revolutional Spinal System that is used provide stabilization to the spinal column in adult patients who suffer from vertebral instability and who have undergone spinal fusion.

The products offer a sterile, innovative set of tools for surgeons who can use them to perform both open and minimally invasive posterior spinal procedures of the sacral, lumbar and thoracic segments of the spinal column. All of the instruments and packaging are either disposable, recyclable or biodegradable.

The target marketing groups are free-standing surgical centers and hospitals, and the kits are designed to help health care centers lower costs by circumventing the need to sterilize and repackage traditional instruments. The disposable nature of the products simplifies and streamlines the routine in operating rooms, and the positive response by surgeons and surgical staff who have used the system has been overwhelming.

One of the most significant advantages to the new disposable set is that it offers new, sterile instruments for each individual procedure that is performed. The incidence of post-operative nosocomial infections should decrease because the risk of cross-contamination from instruments will be virtually eliminated.

The recent FDA approval of the disposable spine implant system will result in a rapid adoption of the products by surgery centers, hospitals and surgeons in Santa Monica, Los Angeles and throughout the nation.

If you are interested in learning more about spine procedures or the latest FDA approved spinal treatments, reach out to The Spine Institute Center for Spinal Restoration at 310-828-7757 and schedule an in-person consultation.