Treating VCFs with vertebral augmentation.
Conservative therapy for VCFs includes bed rest, pain medication, muscle relaxants, external back braces, and physical therapy. If there is little or no pain relief, your doctor may recommend vertebral augmentation.
This minimally invasive procedure is done on an outpatient basis and usually requires only local anesthetic and mild sedation, eliminating many of the complications that result from open surgery. In some instances, general anesthesia is advised with a short hospital stay.910 For many patients, vertebral augmentation results in enhanced procedural efficiency and is covered by Medicare and most private insurers.2345678
Symptoms and causes
Contact your physician if you’re exhibiting any of these symptoms:
- Acute back pain
- Subacute back pain
- Intense midline pain
- Referred or band-like radiating pain (not to the legs)
- Unresponsive to medical therapy
Or are part of a risk group listed here:
- History of Osteoporotic fracture(s)
- Low weight
- Steroid use
- Lack of exercise
- Calcium/vitamin D deficiency
Often, vertebral compression fractures (VCFs) are followed by sharp back pain and may lead to chronic pain, kyphosis or dowager’s hump, loss of height and declining health. This progression is often referred to as the downward spiral. Since one fracture can lead to another, it is important that VCFs be diagnosed and treated early.
Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
Procedure animations and testimonials
iVAS Procedure with Cortoss Animation
Procedure animation videoView Now
iVAS Procedure with Cortoss Animation (2:02)
Part Number: 1000-001-318 Rev A
The iVAS inflatable balloon system meets your needs for procedure customization and accuracy based on fracture anatomy and presentation. Featuring a stiff distal catheter for easy insertion into a flexible proximal catheter, iVAS has the features you'd expect for treatment of VCFs. iVAS measures up to your expectations and your expertise.
Stiff distal balloon catheter provides rigidity for smooth insertion.
Flexible proximal catheter allows for easy maneuverability.
The radiopaque markers on the balloon catheter help facilitate accurate visualization and placement of the balloon.
Access Cannula / Stylet
The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement.
Graduation markings on the access cannula assist in measuring needle depth.
From iVAS to our mixer and delivery systems, cements, and needles, our unprecedented portfolio of products lets you customize your treatment approach. Stryker Interventional Spine's innovative solutions are designed to work together seamlessly for ease of use and increased control, helping to provide enhanced procedural efficiency.
The information provided by Stryker Interventional Spine is not meant to be a substitute for professional medical advice. Please consult your physician to discuss any questions you may have regarding your medical condition and the most appropriate treatment option for you.
Needle is guided into fractured vertebrausing fluoroscopy
Hand drill is inserted into the anterior third of the vertebral body to create a pathway
Balloon catheter is inserted into the fractured vertebra
The balloon is inflated, compacting the trabeculae and creating a cavity
Once the balloon is deflated and withdrawn, the cavity is filled with bone cement or bioactive resin
Stabilized vertebral body
Before your procedure
A doctor will do a physical exam and order x-rays and/or other imaging tests such as an MRI, CT, or bone scan. These tests help to determine the location of the fractured vertebra, how recently it occurred, and whether or not vertebral augmentation is the most appropriate treatment. If the patient is pregnant, please tell the doctor before undergoing a vertebral augmentation.
During your procedure
Generally, vertebral augmentation is performed while the patient is awake but sedated. The patient's back is numbed by a local anesthetic. Using x-ray guidance, a balloon is inserted into the fractured vertebra through a small incision. The balloon is then inflated, creating a void or cavity. Once the void is established, the balloon is deflated and removed. The void is then filled with bone cement to stabilize the fracture. As it hardens, the cement forms an internal cast that holds the vertebra in place. The incision is covered with a bandage. During balloon inflation and removal, complications may occur. These include embolism of fat, thrombus, or other materials; retropulsed vertebral fragments; pneumothorax; or pedicle fracture.
After your procedure
After the procedure, the patient will lie on their back for a short period of time while the cement continues to harden. Vital signs will be monitored. Typically, patients are able to go home within a few hours of treatment. If the patient has any signs of wound infection, bleeding, or hematoma, they should contact their healthcare provider immediately.
1000-025-491 Rev A