Physicians Living the Proof
Expertly trained and endlessly passionate, physicians performing the Intracept™ Procedure see the relief from chronic low back pain first hand.
What Physicians Are Saying About Intracept
Robert Ball, MD
Southwest Florida Pain Center, Venice, FL
“The Intracept procedure has revolutionized the treatment of back pain in my practice. I am proud to be one of the first physicians performing this procedure in my region.”
Douglas P. Beall, MD
Clinical Radiology of Oklahoma, Edmond, OK
“I’ve found that the Intracept Procedure has become an indispensable treatment for patients with stable discogenic back pain associated with degenerative disc disease and degenerative endplate changes. It can produce prominent pain relief and improvement in function through incisions even too small to close with a suture or a staple.”
Brian Durkin, DO
NY Health, Port Jefferson Station, NY
“If I see people with Modic changes I say, ‘that’s probably where your back pain is coming from. It’s probably your vertebrogenic endplate changes that are causing your back pain.’ So that’s been a big change in our algorithm. We’ll see patients for the first time and see if we can get them in the portal and treated.”
Erik Ekstrom, MD
Summit Orthopedics, Plymouth, MN
“In the many years of caring for spine conditions, I have found the Intracept treatment to have the greatest life changing impact on chronic low back pain.”
Robert Funk, MD
Indiana Spine Group, Carmel, IN
“With this minimally invasive, outpatient procedure, patients may experience significant relief of their vertebrogenic low back pain without traditional spine surgery. This is a true game changer.”
Anthony Giuffrida, MD
Cantor Spine Center at the Paley Orthopedic & Spine Institute
Fort Lauderdale, FL
“For my patients with chronic low back pain who do not respond to conservative treatment therapies, the Intracept Procedure is a great option. We are now able to treat a part of the spine that we have not treated in the past. This outpatient, minimally invasive procedure targets the pain-sensing basivertebral nerve. By blocking these pain signals, we may alleviate their chronic pain for good.”
Brad Goodman, MD
OrthoAlabama, Birmingham, AL
“The Intracept procedure has been a game changer in my practice for patients with chronic low back pain.”
Sven Hochheimer, MD
Wyoming Spine & Neurosurgery, Cheyenne, WY
“A fantastic minimally invasive option for patients with chronic low back pain.”
Jad G. Khalil, MD
Michigan Orthopaedic Surgeons, PLLC, Southfield, MI
“The understanding of vertebrogenic back pain and the implications of Modic changes have changed the way we approach this subset of patients. As a surgeon, I would ordinarily turn those patients down for surgery. The Intracept Procedure provides a unique solution for this type of pathology. Doctors adopting Intracept have figured out where to put Intracept in their care pathway.”
Paul Lin, MD
OSS Health, York, PA
“This has been one of the most powerful interventions that has developed in my career. Patients are often getting relief for a condition that previously only had surgery as an option.”
Ramana Naidu, MD
California Orthopedics & Spine, Larkspur, CA
“Intracept is addressing an unmet need in chronic low back pain that interventional pain and spine surgery has been challenged by for years.”
Kiran V. Patel, MD
Director, Neurosurgical Pain, Lenox Hill Hospital
“For the right patient with lower back pain, the Intracept procedure is life changing. Of all of the procedures that I perform, it has delivered the most dramatic results for my patients.”
Tyler Ptacek, MD
Rapid City Medical Center Interventional Pain
Rapid City, SD
“The Intracept procedure has improved so many of my patients’ quality of life.”
David Tran, MD
Axion Spine & Neurosurgery, Alpharetta, GA
“Intracept is an innovative, safe, and highly effective treatment for chronic low back pain. Patients may see dramatic, lasting improvements from this minimally invasive procedure, with limited post-procedure pain and a quick recovery time.”
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. See important safety information below.
Physicians: See Indications, Contraindications, and Risks
The Intracept Procedure Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
Use of the Intracept Procedure Intraosseous Nerve Ablation System is contraindicated in:
- Patients with severe cardiac or pulmonary compromise
- Patients where the targeted ablation zone is < 10 mm away from a sensitive structure not intended to be ablated, including the vertebral foramen (spinal canal)
- Patients with active systemic infection or local infection in the area to be treated
- Patients who are pregnant
- Skeletally immature patients (generally < 18 years of age)
- Patients with active implantable pulse generators (e.g., pacemakers, defibrillators)
- Situations where unintended tissue damage may result, based on the clinical assessment by the physician
- Application with electrosurgical instruments NOT tested and specified for use with the Relievant RFG
Patients: See the Indications & Risks Involved
- The Intracept Access Instruments and the Intracept RF Probe are single patient use only. The Introducer Cannula, Diamond Stylet, Bevel Stylet, J-Stylet, Straight Stylet, Drill, and Probe may be used to treat up to a maximum of four (4) vertebrae (L3, L4, L5, S1) on a single patient, while the Curved Cannula may only be used on one (1) vertebra on a single patient.
- As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the Instruments or Probe. Excessive force can result in product failure.
- Prior to the procedure, CT or MRI imaging must be utilized to help define the desired treatment site and define working anatomical landmarks that can be used for mapping access to the treatment site.
- The device should be manipulated only while under fluoroscopic or CT observation.
- DO NOT use this device in the presence of flammable anesthetics, other flammable gases or objects, near flammable fluids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate fire precautions at all times. There is a risk of pooling of flammable solutions under the patient or in body depressions and cavities.
- Fluids pooled in the body depressions and cavities of the patient should be mopped up before RFG is used.
- There is a danger of ignition of endogenous gases (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the RFG).
- Operator may choose to use smoke-plume extraction apparatus, though the indicated procedure is unlikely to produce noticeable smoke
- The Probe is for use WITHOUT a neutral electrode (ie., a grounding pad).
- Discontinue use if inaccurate, erratic or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury.
- Prior to operation, visually inspect the Probe and RF for physical damage, obvious cracks in insulation or loose parts.
- During power delivery, the cable should not come in direct contact with the patient's skin or other patient leads.
- Safety and effectiveness in patients with conditions that are associated with poor bone quality such as osteoporosis have not been established.
CONTRAINDICATIONS
Use of the Intracept Intraosseous Nerve Ablation System is contraindicated in:
- Patients with severe cardiac or pulmonary compromise
- Patients with active implantable pulse generators (e.g. pacemakers, defibrillators)
- Patients where the targeted ablation zone is < 10 mm away from a sensitive structure not intended to be ablated, including the vertebral foramen (spinal canal)
- Patients with active systemic infection or local infection in the area to be treated
- Patients who are pregnant
- Skeletally immature patients (generally ≤ 18 years of age)
WARNINGS
- Do not use if package is opened or damaged as product integrity and/or sterility may be compromised.
- Do not use after the expiration date has passed as product integrity and/or sterility may be compromised.
- Do not re-sterilize or reuse. Re-sterilization or reuse may result in cross contamination, patient infection, or device malfunction.
- Reconditioning, refurbishing, repair or modification of the device to enable further use is prohibited.
- Do not use this product if you have not been properly trained in its use. Physicians using the device should be familiar with the physiology and pathology of the selected anatomy to be treated and be trained in the performance of the chosen surgical technique. Improper surgical use and technique may lead to suboptimal clinical outcomes.
- Read and understand the Instructions For Use ("IFU*) completely prior to use.
- The Intracept System must be used with the Relievant Medsystems RF Generator in order to provide the required treatment parameters.
- Failure of the RFG could result in an unintended increase of output power to the Probe.
- The Intracept RF Probe may interfere and adversely influence the operation of other electronic equipment.