PRESCRIBE CONFIDENCE.


Built on science, tailored for real life, and supported by our personalized concierge care.

Advancing Care with Innovation

Xstim Spine Fusion Stimulator utilizes clinically proven capacitive coupling technology for bone growth stimulation, trusted by healthcare experts for over three decades—now updated for today's patient needs.

  • CAPACITIVE COUPLED BONE GROWTH STIMULATION is BACKED BY ROBUST CLINICAL EVIDENCE (6)

  • ELEGANTLY DESIGNED FOR MODERN LIFE

  • BACKED BY OUR SIGNATURE CONCIERGE CARE

Pre-CLINICAL DATA

In an in vitro study, upregulation of multiple BMPs occurred in as little as 30 minutes of exposure with optimal upregulation at 24 hours of exposure. (1)

Pre-clinical studies have shown that Capacitive Coupling causes significantly higher levels of cellular proliferation than other electrical stimulation technologies. (2)

Human Clinical Trial Data

A systematic review of bone growth stimulation therapies concluded capacitive coupling to have the highest percentage of patients achieving solid fusion versus PEMF and Direct Current stimulation technologies. (3)

Proportion of patients that achieved solid fusion in the intervention (electrical stimulation) and the control (placebo/no stimulation)* groups following lumbar spinal fusion procedures†. CC, capacitive coupling; DC, direct current; PEMF, pulsed electromagnetic field. (5)

The Xstim Spine Fusion Stimulator is supported by clinical results. In this human clinical trial the overall success rate (clinicall and radiographic healing) for all lumbar fusions was 84.7% in the active capacitively coupled group vs. 64.9% in the placebo group. In this same clinical trial, the active capacitively coupled stimulator achieved statistically significant results in a variety of measurements. (6)

Recommended for use by the
North American Spine Society

(4)

MEET XSTIM Spine Fusion Stimulator

The Xstim Spine Fusion Stimulator, a class 3 medical device, is prescribed to assist in spinal fusion healing. It functions by delivering low-level electrical impulses to the fusion area, encouraging the body's innate healing mechanisms. Its fully integrated and streamlined design requires no complicated apps, ensuring easy operation for patients to seamlessly continue their daily routines uninterrupted.

Xstim Spine Fusion Stimulator Components

  • Carrying Case

  • Controller with electrodes

  • Charger & 2 batteries

  • Electrodes and Covers

  • Power Supply & Electrode Lead Wires

  • Belt Clip

Learn More

Welcome to a new era of healthcare excellence, where we seamlessly converge patient care and prescriber satisfaction. We are delighted to introduce our concierge care model for the Xstim Spine Fusion Stimulator, which redefines the way you experience medical device support. At Xstim, Inc. we comprehend the trust that you place in our team, and we are committed to providing the best healthcare experience for both patients and prescribers.

 

Concierge care

Concierge care for patients

  • Personalized Product Training and Education

    Our specialized team of sales and service representatives offers personalized in-person and phone consultations to guide individuals through device fitting and usage.

  • Insurance Coverage Guidance

    Through third-party billing services, we aid patients in understanding whether their insurance plans include coverage for the device as per their benefit plan.

  • Continuous Assistance

    Patients have access to Xstim, Inc. support representatives throughout their therapy for any queries or to reorder additional supplies and accessories.

Concierge care for the Provider

  • Prompt Assistance

    Our efficient team guarantees swift handling of your requests and questions, enabling you to concentrate on your patient's care.

  • Dedicated Liaison

    We designate a coordinator to facilitate seamless communication and coordination between our company and your patient.

  • Continuous Monitoring

    Our commitment extends beyond device fitting. We provide regular updates on your patient's ongoing progress to ensure comprehensive care.

Important Prescribing Information

Description: Xstim Spine Fusion Stimulator passes a specific current between the electrodes in order to promote healing by inducing a therapeutic, low level electrical current at the fusion site. Federal law restricts this device to sale by or on the order of a physician. Prescription (Rx) only. This device is not intended for re-sale.

Indications for Use: The Xstim Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is for prescription use only, and intended for single patient use in adult patients only.

Contraindications: There are no known contraindications.

Warnings: Cardiac pacemakers or cardioverters may be adversely affected by Xstim Spine Fusion Stimulator. The concomitant use of Xstim Spine Fusion Stimulator and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active stimulator device. If there are any observable adverse changes in the pacemaker rhythm or output, Xstim Spine Fusion Stimulator should not be used. The safety and effectiveness of Xstim Spine Fusion Stimulator in pregnant women have not been studied and the effects of Xstim Spine Fusion Stimulator on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with Xstim Spine Fusion Stimulator.

Precautions: The safety and effectiveness of Xstim Spine Fusion Stimulator in individuals with the following conditions have not been studied, and therefore the safety and effectiveness of Xstim Spine Fusion Stimulator in these individuals are unknown: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, osteoporosis, trauma of the lumbar spine. Apply the electrodes after the skin has been cleaned and dried. If erythema develops at the electrode sites, the electrodes should be relocated adjacent to the original sites. If the reaction does not resolve after 48 hours after relocating the electrodes, the patient should be instructed to consult with the physician. Do not submerge or expose Xstim Spine Fusion Stimulator to water. The patient must be instructed to remove Xstim Spine Fusion Stimulator during bathing, showering or swimming. Compliance with the treatment schedule, daily battery pack changes, and replacing the electrodes (1 to 7 days) as needed are essential for proper device function. This system should only be used with components and replacement parts supplied by Xstim Spine Fusion Stimulator. Other components, parts and accessories may not be compatible, and may damage Xstim Spine Fusion Stimulator. If any component does not function properly, contact Customer Service at (844) 228-2067. No attempt should be made to modify or repair Xstim Spine Fusion Stimulator. Patients should be able to use Xstim Spine Fusion Stimulator in accordance with the instructions for use. If a patient cannot comply with these instructions for any reason, use of Xstim Spine Fusion Stimulator is not recommended.

PROVIDER RESOURCES

PROVIDER Brochure

PROVIDER MANUAL

References: (1)  Wang Z, Clark CC, Brighton CT. Up-regulation of bone morphogenetic proteins in cultured murine bone cells with use of specific electric fields. J Bone Joint Surg Am. 2006;88(5):1053-1065.(3). (2)  Brighton CT, Wang W, Seldes R, Zhang G, Pollack SR. Signal transduction in electrically stimulated bone cells. J Bone Joint Surg Am. 2001;83-A(10):1514-1523. (3) Park P, Lau D, Brodt ED, Dettori JR. Electrical stimulation to enhance spinal fusion: a systematic review. Evid Based Spine Care J. 2014 Oct;5(2):87-94. doi: 10.1055/s-0034-1386752. PMID: 25278882; PMCID: PMC4174185 (4)  https://www.spine.org/Product-Details?productid=%7B3D71338D-AF81-E611-851E-005056AF031E%7D (5) Proportion of patients that achieved solid fusion in the intervention (electrical stimulation) and the control (placebo/no stimulation)* groups following lumbar spinal fusion procedures†. CC, capacitive coupling; DC, direct current; PEMF, pulsed electromagnetic field. *The following RCTs used a placebo device in the control group: Anderson 2009, Goodwin 1999, Linovitz 2002, and Mooney 1990. †Marked heterogeneity in study population and design was present across the six RCTs. Anderson 2009: Elderly population (mean age 70 years); industry sponsored/funded; random sequence generation not reported; no intention-to-treat analysis; did not control for possible confounding factors. Goodwin 1999: Industry sponsored/funded; random sequence generation and statement of concealed allocation not reported; no intention-to treat analysis; unclear if cointerventions were applied equally; < 80% of patients followed. Jenis 2000: patient diagnoses not reported; funding/conflicts of interest not reported; statement of concealed allocation not reported; no intention-to-treat analysis; < 80% of patients followed; did not control for possible confounding factors. Kane 1988: Age and % male not reported; difficult spinal fusions; no definition of fusion outcome provided; funding/conflicts of interest not reported; statement of concealed allocation not reported; no intention-to-treat analysis; unclear if cointervention were applied equally. Linovitz 2002: Industry sponsored/funded; statement of concealed allocation not reported. Mooney 1990: Younger population (mean age 38 years); random sequence generation and statement of concealed allocation not reported; no intention-to-treat analysis; unclear if cointervention were applied equally. ‡These studies did not report p values; p values were calculated by this article's authors using the STATA software program. (6) Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999;24(13):1349-1356.