Cervical-Stim
Cervical-Stim offers the security of proven, safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients.
It offers the comfort of an external device that patients tell us is the most effortless treatment they have ever experienced. Not to mention the comfort enjoyed with improved clinical outcomes: In a PMA study of 323 high-risk ACDF patients, 84% achieved fusion within six months using Cervical-Stim vs. 69% for those who did not receive treatment.
1 Additionally, the data from this study prove for the first time that fusion has a positive effect on VAS and NDI clinical outcomes after ACDF.
2
Since 1990, more than 200,000 spine fusion patients have healed with bone growth stimulation from Orthofix. We brought you the first and most effective external bone growth stimulator for lumbar fusion, and now offer you the only FDA approved device to increase the rate of cervical fusion success.
- Comfortably worn during daily activities, with or without a cervical brace, four hours per day
- Proven to overcome risk factors for nonfusion
- Next generation design with smart technology and patient friendly functionality
Indication
The Cervical-Stim is a noninvasive, pulsed electromagnet bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for nonfusion.
Physician Benefits
- Safe and effective bone growth stimulation to significantly increase the rate of cervical fusion success in high-risk patients
- Smart technology can provide outcomes reports and hardcopy patient compliance monitoring
- Written guarantee for bone growth stimulation products
- The only FDA approved bone growth stimulator for cervical fusion
- Patient friendly, comfortably worn during daily activities with or with a cervical brace, four hours per day
Footnotes:
1. Results from Orthofix Inc. PMA Randomized, Prospective Controlled Clinical
Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion, 2004.
2. Anterior Cervical Discectomy and Fusion: Correlation of Fusion Status with
Clinical Outcome, Kevin Foley, M.D., Neurosurgery. Presented at the NASS 20th Annual Meeting, Philadelphia, PA
Spinal-Stim
Spinal-Stim delivers the highest success rates in bone growth stimulation for spine fusion and nonoperative salvage. In fact, 92% of patients receiving Spinal-Stim adjunctively have achieved fusion success
1. When treating failed fusion with Spinal-Stim, 67% of patients achieve successful fusion with no additional surgery
2. Spinal-Stim offers:
- Proven Field Coverage
- Risk Factor Coverage
- Guarantee Program
- Insurance Acceptance
- FDA Approved Models for Both Cervical and Lumbar Spine
Indication
The Spinal-Stim is a noninvasive electromagnetic bone growth stimulator indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
1
Physician
Benefits
- Proven Field Coverage
- Risk Factor Coverage
- Guarantee Program
- Insurance Acceptance
- Smart technology can provide outcomes analysis and hardcopy patient compliance monitoring
Footnotes:
1. Spinal-Stim Summary of Safety and Effectiveness. P850007/S6. February 7, 1990. One-Year Postoperative Pre-Marketing Data From Randomized Double-Blind Placebo-Controlled Clinical Trial.
2. Spinal-Stim Summary of Safety and Effectiveness. P850007/S6. February 7, 1990. One Year Follow-up, Pre-Marketing Data, Open Trial, Pseudoarthrosis Stratum Clinical Study.
Physio-Stim
The Pulsed ElectroMagnetic Field (PEMF) bone growth stimulation delivered by Physio-Stim is a safe, nonsurgical option for long bone and small bone nonunions. Physio-Stim may be worn over a cast, orthopedic brace, or clothing without lessening its effectiveness. Physio-Stim has everything you need in one compact, lightweight unit including success rates as high as 88%
1, 2, and it comes with a written guarantee of healing.
Nonoperative treatment for nonunited fractures with Physio-Stim PEMF bone growth stimulation is particularly attractive to patients and physicians when:
- Surgery presents significant risk to the patient
- The patient does not want to undergo surgery
- Multiple procedures have previously failed
Regardless of prior fracture management method or risk considerations - including advanced age, presence of infection or tobacco use, the Physio-Stim Bone Growth Stimulator has more than two decades of proven efficacy as an alternative method to secondary surgery for established long bone fracture nonunions.
Indication
The Physio-Stim is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibily progressive signs of healing.
Footnotes:
1. Physio-Stim PMA 850007 – 02/21/86, Supplement – 12/23/86
2. "Long-term Follow-up of Fracture Nonunions Treated with PEMFs" – Douglas E.
Garland, M.D., Barbara Moses, M.B.A., B.S.N., R.N., William Salyer, M.D.
