FDA Greenlights Xstim™ Spine Fusion Stimulator: Xstim, Inc. Achieves Landmark Approval

Wednesday, April 17, 2024

Xstim is proud to announce the recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for the Xstim™ Spine Fusion Stimulator. This approval represents a significant milestone for the company, renowned for its cutting-edge bone growth stimulation systems. Engineered with patient comfort and convenience in mind, the Xstim™ Spine Fusion Stimulator is set to revolutionize spinal fusion rehabilitation.

Utilizing capacitively coupled technology, the Xstim™ Spine Fusion Stimulator emits a low-energy signal that has been clinically proven to enhance bone healing after spinal fusion surgery. This innovative device is scheduled for commercial availability in the second quarter of this year, with a phased launch plan in place to ensure widespread accessibility.

Designed with a focus on patient-friendly use and wearability, the Xstim™ Spine Fusion Stimulator offers a noninvasive alternative for indicated cases. Its intuitive interface and sleek design, complete with a large onboard color display, simplify patient therapy management. Patients can now experience seamless and hassle-free rehabilitation with the Xstim™ device.

Xstim is committed to advancing spinal fusion rehabilitation and empowering both patients and surgeons. The approval of the Xstim™ Spine Fusion Stimulator marks the beginning of a promising pipeline of bone growth stimulation innovations. With its dedication to excellence and innovation, Xstim, Inc. aims to elevate the standard of care in spinal fusion therapy.

Source: prnewswire.com