2
Relievant and Intracept are registered trademarks of Relievant Medsystems, Inc. ©2017 Relievant Medsystems, Inc. All rights reserved. MKT 0023, Rev B For more information about the INTRACEPT Clinical Study, please visit www.IntraceptStudy.com AM I A CLINICAL STUDY CANDIDATE? If you suffer from chronic low back pain, you may be a candidate for the INTRACEPT Clinical Study. The study is evaluating the Intracept Procedure—a minimally invasive procedure for the relief of chronic low back pain. INITIAL QUALIFICATION CRITERIA Age 25 to 70 History of chronic low back pain for at least six (6) months Have not received adequate relief through non-operative, conservative treatments of at least six (6) months Available to complete specific tests, questionnaires and follow-up visits over a 24-month period If you qualify and choose to participate, you will be treated by a local spine specialist and will receive all study-related care at no cost. This includes the Intracept Procedure, as well as any examinations or visits associated with the study. Information about the INTRACEPT Clinical Study Find out if you qualify for participation Chronic Low Back Pain?

AM I A CLINICAL STUDY CANDIDATE? Chronic Low Back Pain?€¦ · a minimally invasive procedure for the relief of chronic low back pain. During the procedure, doctors make a small

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: AM I A CLINICAL STUDY CANDIDATE? Chronic Low Back Pain?€¦ · a minimally invasive procedure for the relief of chronic low back pain. During the procedure, doctors make a small

Relievant and Intracept are registered trademarks of Relievant Medsystems, Inc.

©2017 Relievant Medsystems, Inc. All rights reserved.

MKT 0023, Rev B

For more information about the INTRACEPT Clinical Study, please visit

www.IntraceptStudy.com

AM I A CLINICAL STUDY CANDIDATE?

If you su� er from chronic low back pain, you may be a candidate for the INTRACEPT Clinical Study. The study is evaluating the Intracept Procedure—a minimally invasive procedure for the relief of chronic low back pain.

INITIAL QUALIFICATION CRITERIA

• Age 25 to 70

• History of chronic low back painfor at least six (6) months

• Have not received adequate relief through non-operative, conservative treatments of at least six (6) months

• Available to complete specifi c tests,questionnaires and follow-up visits over a 24-month period

If you qualify and choose to participate, you

will be treated by a local spine specialist and will receive all study-related care at no cost. This includes the Intracept Procedure, as well as any examinations or visits associated with the study.

Information about theINTRACEPT Clinical Study

Find out if you qualify for participation

Chronic Low Back Pain?

Page 2: AM I A CLINICAL STUDY CANDIDATE? Chronic Low Back Pain?€¦ · a minimally invasive procedure for the relief of chronic low back pain. During the procedure, doctors make a small

The Intracept® Procedure for Chronic Low Back Pain

A CHRONIC PROBLEMChronic low back pain is the most prevalent and expensive nonlethal medical condition in the United States, and is responsible for sending millions of patients to their doctors for treatment every year. When conservative remedies fail to relieve pain, many patients are faced with an unsettling future—escalating use of pain medications, major spine surgery, or continued su� ering.

WHAT CAUSES CHRONIC LOW BACK PAIN?Although chronic low back pain has many causes, it is believed that one of the key contributing factors is the basivertebral nerve. The basivertebral nerve is a pain-sensing nerve that is embedded within the bones of the spine, called vertebrae. This nerve branches to the surfaces of the vertebrae, exposing it to the everyday movements and stresses placed on the spine.

Over time, accumulated stress on the vertebrae can put pressure against this exposed nerve, causing severe low back pain—even during normal, everyday movement. The pain triggered by the nerve may force su� erers to avoid a variety of activities, taking a substantial toll on overall quality of life.

If you su� er from chronic low back pain, you may be a candidate for the INTRACEPT Clinical Study. The study is evaluating the Intracept Procedure—a minimally invasive procedure for the relief of chronic low back pain.

During the procedure, doctors make a small (3–5mm) incision in the lower back. Following this, a specialized probe is advanced into the vertebrae and positioned at the precise location of the pain-sensing basivertebral nerve. Once positioned, the Intracept probe uses radiofrequency energy (heat) to disable the basivertebral nerve, rendering it unable to transmit pain signals.

Indications and Risks:

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 either Type 1 or Type 2 Modic changes on an MRI.

The information provided by Relievant Medsystems, Inc. is not intended to be a substitute for professional medical advice. The Intracept Procedure, as with any surgical procedure, has risks that should be discussed with your medical professional.

Intracept Procedure Steps

Basivertebral Nerve

Vertebrae

Intracept probe advanced into vertebrae and positioned at the basivertebral nerve

1

Radiofrequency energy (heat) delivered to the nerve

2

The nerve is disabled, rendering it unable to transmit pain signals

3

For more information about the INTRACEPT Clinical Study, please visit www.IntraceptStudy.com