US-based medical technology company Xstim has received the US Food and Drug Administration (FDA) approval for Xstim Spine Fusion Stimulator.

Xstim said that its spine fusion stimulator has been engineered considering patient comfort and convenience and represents a significant milestone in its portfolio of bone growth stimulators.

The capacitively coupled device is designed to emit a low-energy signal, which is clinically proven to promote bone healing after spinal fusion surgery.

The medical technology company intends to commercialise the device in the second quarter of this year, with a targeted and phased launch plan to ensure widespread accessibility.

Xstim CEO Jeremy Perkins said: “Xstim, Inc. is dedicated to empowering patients and surgeons to elevate the quality of care in spinal fusion rehabilitation.

“The introduction of the Xstim Spine Fusion Stimulator represents the beginning of our robust pipeline of bone growth stimulation innovations.

“We are poised to collaborate with healthcare providers and distribution partners to enhance bone fusion outcomes and elevate patient satisfaction. This FDA approval underscores our leadership in and dedication to the bone growth stimulation market.”

Xstim said that its spine fusion stimulator has been designed to prioritise patient ease of use and wearability, offering a non-invasive alternative for indicated cases.

It comes with an intuitive interface, and sleek design, and features a large onboard colour display to streamline patient therapy management.

Orthopaedic surgeon Adam Bruggerman said: “Bone healing following spinal fusion surgery is paramount to successful patient outcomes. The availability of non-invasive bone growth stimulation options like Xstim provides my patients with an invaluable advantage.

“Its sleek design ensures simple therapy management without the hassle of downloading and managing extra apps.”

In August 2022, Theragen received the US Patent for the development of the ActaStim-S spine fusion bone growth stimulator system.

ActaStim-S is a spine fusion stimulator that combines modern design, a data-rich digital health platform, and scientifically tested therapeutic stimulation.

The system supports patient recovery, compliance, involvement, and informed conversation with healthcare professionals during the crucial and drawn-out post-operative fusion phase.