• METRx® System
  • KYPHON® Balloon Kyphoplasty
  • INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device
  • O-arm® Surgical Imaging System

It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment. 

The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.

METRx® System

Potential risks to any surgical procedure include unforeseeable complications caused by anesthesia, blood clots, undiagnosed medical problems, such as silent heart disease, and rare allergic reactions. There are some risks associated with minimally invasive spine surgery, including transitioning to a conventional open procedure, neurological damage, damage to the surrounding soft tissue and, where used, instrument malfunction. Most of these complications can be treated once they are detected, but sometimes they require a longer period of hospitalization or recovery, additional medications, and sometimes even additional surgery. Depending upon the type of surgery you are having, these risks will be explained by the primary surgeon. As a patient, it is important to understand and follow your doctor’s advice so that the best possible outcome can be achieved. This surgery is not for everyone. Please consult your physician. A prescription is required.

It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.

KYPHON® Balloon Kyphoplasty

The complication rate for KYPHON® Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure, including serious complications, and though rare, some of which may be fatal. These include, but are not limited to heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs, heart, or brain). Other complications include infection and leakage of bone cement into the muscle and tissue. Cement leakage into the blood vessels may result in damage to the blood vessels, lungs, heart, and/or brain. Cement leakage into the area surrounding the spinal cord may result in nerve injury that can, in rare instances, cause paralysis. A prescription is required. Please consult your physician for a complete list of indications, contraindications, benefits, and risks. Only you and your physician can determine whether this procedure is right for you.

It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.

INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE® BONE GRAFT/LT-CAGE® LUMBAR TAPERED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX THREADED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX™ RP THREADED FUSION DEVICE

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. The INFUSE® Bone Graft/ LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. INFUSE® Bone Graft with either the INTER FIX™ or INTER FIX™ RP Threaded Fusion Device is to be implanted via an anterior open approach.

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device consists of two components containing three parts– a metallic spinal fusion cage, a recombinant human bone morphogenetic protein and a carrier/scaffold for the bone morphogenetic protein and resulting bone. These components must be used as a system for the prescribed indication described above. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. The INFUSE® Bone Graft component must not be used without the Medtronic Titanium Threaded Interbody Fusion Device component.

NOTE: The INTER FIX Threaded Fusion Device and the INTER FIX RP Threaded Fusion Device may be used together to treat a spinal level. LT-CAGE® Lumbar Tapered Fusion Device implants are not to be used in conjunction with either the INTER FIX or INTER FIX RP implants to treat a spinal level.

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor; in patients with any active malignancy or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium or titanium alloy.

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate INFUSE® Bone Graft kit.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.

O-arm® Surgical Imaging System

For full details, please refer to your System Manual.

Intended Use:
The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.

United States law restricts this device to sale, distribution, and use by or on the order of a physician.

Use of Video Graphics Printer
Printouts from the optional Video Graphics Printer are not intended to be used for diagnostic purposes. The printer's primary use is for physician reference and documentation.

Use of the DVD/CD RW Drive
Information stored on DVDs is not intended to be used for diagnostic purposes. The primary use of such information is for physician reference and documentation.

Equipment Users
Users of the O-arm Imaging System should be trained, licensed, and/or certified in the proper use of medical x-ray equipment and its medical applications. Users should read this user manual and the labels on the Image Acquisition System (IAS) and the Mobile View Station (MVS).

Safety Overview
Potential hazards exist in the use of medical electronic devices and X-ray systems such as the O-arm Imaging System. Personnel using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided in the User Manual.

It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.