Intacept



SMART 5-Year Data
Demonstrates Long-Term
Relief SMART 5-Year Data Demonstrates Long-Term Relief SMART 5-Year Data
Demonstrates Long-Term
Relief SMART 5-Year Data Demonstrates Long-Term Relief SMART 5-Year Data
Demonstrates Long-Term
Relief SMART 5-Year Data Demonstrates Long-Term Relief in Chronic Vertebrogenic
Low Back Pain Vertebral
Endplates The Role of in Chronic Vertebrogenic Low Back Pain Vertebral Endplates The Role of for the Relief of Chronic
Vertebrogenic Low Back Pain The Intracept
Procedure The Intracept Procedure for the Relief of Chronic Vertebrogenic
Low Back Pain Relievant’s New
Patient Education Website Visit
Intracept.com Visit Intracept.com Relievant’s New
Patient Education Website

We are committed to providing new solutions to the millions of patients suffering from chronic low back pain (CLBP). At any given time, low back pain impacts nearly 30% of the US population, leading to 52 million annual visits to hospitals, emergency departments, outpatient clinics, and physician offices.1 While the majority of patients with low back pain improve, up to 15% of these patients experience chronic low back pain.2

Intacept Security. 271 likes 6 talking about this. A leading corporate property and facilities Security company. Intacept 50mg Injection is a biological medicine which is used for treating inflammatory conditions such as rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis. Intacept 50mg Injection blocks the TNF. Buy Intacept 50 mg Etanercept Injection online at best price from India to treat Arthritis. SUPPLY WORLDWIDE. Read About Intacept 50mg (1 ml in 1 Vial) made by Intas, Uses, MRP, Substitutes @Drugssquare.com. The Intracept Procedure is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain. Key Benefits of Intracept Provides a treatment option for patients who have not responded to conservative therapy Minimally invasive, outpatient procedure.

Today, patients with CLBP are treated with conservative treatments such as physical therapy or injections, medications such as opioids, or potentially surgical options including spinal fusion or total disc replacement. Unfortunately, conservative treatments do not provide adequate relief for the majority of patients and only a small percentage are surgically eligible.

The focus has traditionally been on the intervertebral discs as the primary source of CLBP, known as discogenic pain. Research published over the past 20 years has concluded that vertebral body endplates are a significant source of CLBP. This pain is referred to as vertebrogenic pain and is transmitted via the basivertebral nerve, which is found within the vertebral body.

Based on this research, Relievant developed the Intracept Procedure — a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain.* Intracept, commercially available in the US, is supported by two Level I randomized controlled trials in addition to long-term durability data showing functional and pain improvements are maintained beyond 5 years.

We are committed to providing new solutions to the millions of patients suffering from chronic low back pain (CLBP). At any given time, low back pain impacts nearly 30% of the US population, leading to 52 million annual visits to hospitals, emergency departments, outpatient clinics, and physician offices.1 While the majority of patients with low back pain improve, up to 15% of these patients experience chronic low back pain.2

Today, patients with CLBP are treated with conservative treatments such as physical therapy or injections, medications such as opioids, or potentially surgical options including spinal fusion or total disc replacement. Unfortunately, conservative treatments do not provide adequate relief for the majority of patients and only a small percentage are surgically eligible.

The focus has traditionally been on the intervertebral discs as the primary source of CLBP, known as discogenic pain. Research published over the past 20 years has concluded that vertebral body endplates are a significant source of CLBP. This pain is referred to as vertebrogenic pain and is transmitted via the basivertebral nerve, which is found within the vertebral body.

Based on this research, Relievant developed the Intracept Procedure — a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain.* Intracept, commercially available in the US, is supported by two Level I randomized controlled trials in addition to long-term durability data showing functional and pain improvements are maintained beyond 5 years.

“The Intracept Procedure is a new, minimally invasive option to treat chronic vertebrogenic low back pain. The procedure has been proven to be safe and effective in clinical trials, and is much less invasive than typical surgical options to treat vertebrogenic pain.”

Jeffrey Fischgrund, MD, Chairman, Department of Orthopedics, Beaumont Hospital, Royal Oak and principal investigator of the SMART Trial

“The Intracept Procedure is a new, minimally invasive option to treat chronic vertebrogenic low back pain. The procedure has been proven to be safe and effective in clinical trials, and is much less invasive than typical surgical options to treat vertebrogenic pain.”

Jeffrey Fischgrund, MD, Chairman, Department of Orthopedics, Beaumont Hospital, Royal Oak and principal investigator of the SMART Trial
Intacept

The Intracept Procedure is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain.

Intercept Definition

  • Provides a treatment option for patients who have not responded to conservative therapy
  • Minimally invasive, outpatient procedure
  • Implant-free and preserves the structure of the spine
  • Provides durable relief of chronic vertebrogenic low back pain1

  • 1Access the pedicle

    Under fluoroscopic guidance, the Intracept Introducer Cannula is advanced through the pedicle

  • 2Create the channel

    The Intracept Curved Cannula is utilized to create a channel to the trunk of the basivertebral nerve

  • 3 Place the RF Probe

    The Intracept Radiofrequency Probe is inserted into the curved path and placed at the basivertebral nerve

  • 4 Ablate the BVN

    The Relievant Radiofrequency Generator is utilized to ablate the basivertebral nerve

  • Chronic Low Back Pain of at least 6 months
  • Not responded to at least 6 months of conservative care
  • Type 1 or Type 2 Modic changes on an MRI (Figure 2)

The Intracept 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 Intraosseous Nerve Ablation System is contraindicated in:

Spine Intracept Procedure

  • 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 implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants
  • 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

As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. To review the contraindications, warnings and precautions click here.

Intacept

Intacept 50

T1W

T2W

Modic Type 1:

Hypointense T1W and Hyperintense T2W MR

Modic Type 2:

Hyperintense T1W and T2W MR

Figure 2

Contraindications

Use of the Intracept Intraosseous Nerve Ablation System (Intracept 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 implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic implants.
  • 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.

Warnings

  • Do not use the Intracept System if package is opened or damaged as product integrity and/or sterility may be compromised.
  • Do not use the Intracept System after the expiration date has passed as product integrity and/or sterility may be compromised.
  • Do not re-sterilize or reuse Intracept System. 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 the Intracept System or Relievant RFG (RFG) if you have not been properly trained in its use. Physicians using the Intracept System 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.
  • Failure of the RFG could result in an unintended increase of output power to the Probe.
  • The Probe may interfere and adversely influence the operation of other electronic equipment.
  • Federal law (USA) restricts this device to use by, or on order of, a physician.
  • Attempt no internal repairs or adjustments not specifically detailed in the RFG manual. Refer any readjustments, modifications, and/or repairs to Relievant Medsystems or its authorized representatives.
  • Pay close attention to the care and cleaning instructions in the RFG maunal. Failure to follow these instructions may result in product damage.
  • Install the RFG in a room that complies with all locally applicable requirements (including and not limited to IEC, CEC, and NEC) for safety and electromagnetic compatibility of high-frequency electrical surgical equipment.
  • DO NOT use the Relievant RFG on patients with implantable pulse generators (e.g., pacemakers, defibrillators) or other electronic device implants. Doing so could lead to electromagnetic interference and possible death.
  • No modification of the RFG is allowed.
  • To avoid the risk of electric shock, the RFG must be connected only to a supply mains with protective earth.
  • Failure of the RFG could result in an unintended increase in output power.
  • Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur. The RFG has been designed to minimize the possibility of neuromuscular stimulation.
  • Operator may choose to use smoke-plume extraction apparatus, though the indicated procedure is unlikely to produce noticeable smoke.
  • The RFG is for use WITHOUT a neutral electrode (i.e., a grounding pad).
  • The separable AC power cord is provided as a means of emergency shut down and disconnection from the power source. DO NOT position the Relievant RFG in a way that is difficult to disconnect the AC power cord.
  • Discontinue use if in accurate, erratic or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury.

Precautions

  • 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 Intracept System should be manipulated only while under fluoroscopic or CT observation.
  • DO NOT use the RFG 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).
  • The Probe is for use WITHOUT a neutral electrode (i.e., a grounding pad).
  • Prior to operation, visually inspect the Probe and RFG 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.