Xstim Spine Fusion Stimulator – P230025
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: Xstim Spine Fusion Stimulator
PMA Applicant: Xstim Inc.
Address: Xstim Inc.,1320 Greenway Drive, Suite 200-F, Irving, Texas 75038 USA
Approval Date: February 9, 2024
Approval Letter: Approval Order
What is it?
The Xstim Spine Fusion Stimulator is a bone growth stimulator (BGS) device intended be used on the lower back. The device components include a controller for creating signals, a belt clip, a rechargeable lithium-ion battery pack and charging unit, controller cables, hydrogel electrode pads that stick to the skin, optional electrode covers, including some for use only when showering, and a carry case.
After a spinal fusion procedure, the Xstim Spine Fusion Stimulator electrodes are placed on the lower back, with one on each side of the area of the spine being fused. Once the device is on and electrodes are detected, the device starts “Treatment Mode,” automatically delivering a 60 kHz sine wave between the electrodes to create a low energy electrical field at the fusion site, to activate and support spinal fusion.
The Xstim Spine Fusion Stimulator is indicated as an additional electrical treatment after lumbar spinal fusion surgery for one or two levels of the spine. The person would first have surgery considered standard treatment, which includes:
- Placing a fusion device into the body.
- Plates.
- Pedicle screws and rods.
The Xstim Spine Fusion Stimulator is an additional treatment device which is used by a person:
- Following surgery.
- At home all day for nine months.
This device is available by prescription and intended for adult patients only.
The safety and effectiveness of the Xstim Spine Fusion Stimulator can be understood from the data used to approve the SpinalPak, a similar BGS device. In a randomized, placebo-controlled study of SpinalPak, 349 people were observed for safety, with 215 of these 349 people observed for effectiveness. Success was based on a combination of X-ray images and a doctor’s review of the fusion. After one year, 87 of 110 people with an active device achieved success, compared to 64 of 105 people with a placebo device.
There are no known situations when this device should not be used (contraindications).
- Summary of Safety and Effectiveness Data (SSED)
- Labeling - Provider Manual Instructions for Use
- Labeling Part 2 - Patient Instructions for Use
- PMA Database entry