Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device.
Irving, Texas-based Xstim designed its capacitively coupled device to emit a low-energy signal. This, in turn, promotes bone healing following spinal fusion surgery.
The company plans to make the device commercially available in the second quarter of this year. It has plans for a phased launch to ensure widespread accessibility.
Related: IceCure submits final breast cancer cryoablation data to FDA
Xstim designed its device with patient comfort and ease of use in mind, according to a news release. The company said it prioritized wearability, offering a non-invasive alternative for indicated cases. It features an intuitive interface and a sleek design with a large onboard color display.
The company says the FDA nod highlights its commitment to enhancing spinal fusion rehabilitation standards. Jeremy Perkins, Xstim CEO, said the company wants to empower patients and surgeons to elevate the quality of care in spinal fusion rehab.
“The introduction of the Xstim Spine Fusion Stimulator represents the beginning of our robust pipeline of bone growth stimulation innovations,” said Perkins. “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.”
