SI-BONE

iFuse Implant System_®

Minimally Invasive Sacroiliac Joint Surgery

iFuse Implant System_®

Minimally Invasive Sacroiliac Joint Surgery

It’s time to get your life back.

Don’t let lower back pain stop you from living your life. Did you know that up to 25% of chronic lower back pain is caused by the sacroiliac joint?¹ If you’re having symptoms that may be related to your sacroiliac joint, talk to your doctor about your options including the iFuse Implant System® ("iFuse"), an option for some causes of SI joint pain or dysfunction. SI joint treatment using the patented triangular design of the iFuse Implant™, available since 2009, has produced unparalleled clinical results. More than thirty published, peer-reviewed articles demonstrate safety and effectiveness of the iFuse Implant.² The iFuse Implant is the only SI joint fusion device with multiple clinical studies demonstrating that treatment improved pain, patient function, and quality of life.³

For information about the risks of the iFuse Procedure, visit: www.si-bone.com/risks

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Find out more about iFuse.

Studies show that up to 25% of chronic low back pain is sacroiliac joint in origin and that the diagnosis of sacroiliac joint disease is frequently overlooked by physicians.¹ The economic burden of SI joint dysfunction among privately-insured patients in the US is substantial, highlighting the need for more cost-effective therapies.⁴ We’ve developed a minimally invasive sacroiliac implant system for SI joint dysfunction caused by SI joint disruptions and degenerative sacroiliitis. SI joint treatment using the patented triangular design of the iFuse Implant™, available since 2009, has produced unparalleled clinical results. Learn more about the published, peer-reviewed articles that demonstrate safety and effectiveness of the iFuse Procedure.² The iFuse Implant is the only SI joint fusion device with multiple clinical studies demonstrating that treatment improved pain, patient function, and quality of life.³

For information about the risks of the iFuse Procedure, visit: www.si-bone.com/risks

Cohen, Steven P. Sacroiliac Joint Pain: A Comprehensive Review of Anatomy, Diagnosis, and Treatment. Anesth Analg 2005; 101:1440-1453.
Polly, D.W. et al., Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.Int J Spine Surg. 2016; 10:Article 28.— Dr. Polly is an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE. Research was funded by SI-BONE, Inc. A list of additional published studies is available at www.si-bone.com/results
Duhon, B* et al., Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. * Paid consultant of and conducts clinical research for SI-BONE Inc.Research was funded by SI-BONE, Inc.
Ackerman SJ, et al., Management of sacroiliac joint disruption and degenerative sacroiliitis with nonoperative care is medical resource-intensive and costly in the United States commercial payer population. Clinicoecon Outcomes Res 2014;6:63-74. *Research was sponsored by SI-BONE, Inc.

At 5 years, 82% of patients were satisfied, indicating they would have the same surgery again for the same result.

- Rudolf 2014 ¹

Unique Design

Triangular implants designed specifically to stabilize and fuse the heavily loaded SI joint.

Strength of Experience

More than 25,000 procedures have been performed with the iFuse Implant System - the method of choice for SI joint fusion.^SM

Clinically Proven

More than thirty published, peer-reviewed articles demonstrate safety and effectiveness of the iFuse Implant.²

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

Rudolf, Leonard*. "Five-Year Clinical and Radiographic Outcomes After Minimally Invasive Sacroiliac Joint Fusion Using Triangular Implants." The Open Orthopaedics Journal. 2014;8:375-383. * Paid consultant, ownership interest, and conducts clinical research for SI-BONE Inc.Research was funded by SI-BONE, Inc.
Polly, D.W. et al., Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.Int J Spine Surg. 2016; 10:Article 28.— Dr. Polly is an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE. Research was funded by SI-BONE, Inc. A list of additional published studies is available at www.si-bone.com/results

IMPORTANT SAFETY INFORMATION

INDICATIONS

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

CONTRAINDICATIONS

Deformities or anatomic variations that prevent or interfere with iFuse placement.
Tumor of sacral or ilial bone.
Active infection at treatment site.
Unstable fracture of sacrum and or ilium involving the sacroiliac joint.
Allergy to metal components

WARNINGS

Women of childbearing potential should be cautioned that vaginal delivery of a fetus may not be advisable following SI joint fusion. If pregnancy occurs, the woman should review delivery options with her obstetrician.

PRECAUTIONS

Carefully read and follow all instructions prior to use.
Patient adherence to post-operative physical activity instructions is important to support long-term service life of the implant.
Pay careful attention to selection of implant size. Pre- operative X-rays and/or CT scan may be helpful in selecting implant size.
Appropriate patient selection is necessary as patient factors such as size and weight m y make use of iFuse more difficult or impossible.
Inspect iFuse Implants and delivery instruments for damage prior to use. Do not use if damaged or worn. Do not attempt to repair.
Do not use any component from an opened or damaged package.
Do not use implants after the expiration date.

MRI SAFETY AND COMPATIBILITY

MR Conditional

The iFuse Implant is MR conditional. Non-clinical testing demonstrated that the iFuse Implant is MR conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

Static magnetic field of 1.5-Tesla and 3-Tesla, only
Maximum spatial gradient magnetic field of 720-Gauss/cm or less
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Normal Operating Mode of operation for the MR system

Under the scan conditions defined above, the iFuse Implant is expected to produce a maximum temperature rise of less than 3.1 ºC after 15 minutes of continuous scanning. The image artifact extends approximately 20 mm from the device, when scanned in nonclinical testing using a gradient echo (GRE) pulse sequence in a 3-Tesla (Excite, Software 14X.m5, General Electric Healthcare) MR system with a send- receive RF coil.

Surgeons should advise patients that the iFuse Implant is MR conditional with details available at:
www.si-bone.com

RISKS

As with other surgical procedures used to treat SI joint conditions, the risks associated with the iFuse surgical procedure include, but are not limited to the following:

Adverse reactions to anesthesia
Hemorrhage
Muscle damage
Hematoma or seroma
Neurological deficit, nerve root or peripheral nerve injury, irritation or damage
Vascular injury or damage that may result in catastrophic or fatal bleeding
Neurovascular injury
Damage to lymphatic vessels and/or lymphatic fluid exudation
Injury to intra-pelvic structures
Infection of the wound, deep infection, peritonitis
Wound dehiscence
Pulmonary or systemic embolism
Thrombosis, thrombophlebitis
Death
Bruising
Local swelling
Radiation exposure

Potential risks specifically associated with the iFuse Implants or Delivery System include, but are not limited to the following:

Infection
Pain, discomfort, or abnormal sensations due to presence of the implant
Instrument failure resulting in a complication
Migration, loosening or fracture of the implant
Pain in muscle due to altered biomechanics
Nerve root or peripheral nerve root irritation due to local swelling or altered biomechanics
Loss of fixation / stabilization
Metal sensitivity or allergic reaction
Failure to improve symptoms and/or function
Increased pain at treated or adjacent levels
Need for re-operation or removal of the implant(s)
Implant rejection
Response to wear debris
Decrease in bone density due to stress shielding
Failure to achieve SI joint fusion
Potential difficulty in delivering fetus vaginally due to device-related restriction of SI joint stretching

Click here to download the Instructions for Use.