Kyphoplasty System Products (CE MDR Certificate and FDA Approval)
Components of Kyphoplasty System Products:
Kyphoplasty Balloon Catheter: The device is mainly used in PKP operation to dilate vertebral body and form a cavity, which is for injecting bone cement to recover and stabilize vertebral body.
Kyphoplasty Tool Kit: The device is mainly used for bone percutaneous intervention and establishing working channel by medical institutions.
Balloon Inflator: The device is mainly used for hydraulic pressure on balloons to achieve the functure of balloon dilation.
Features:
Minimally invasive surgery can reduce tissue injury and blood loss;
The operation is simple, fast, and the operation time is greatly shortened;
Local anesthesia can be adopted to reduce the risk of surgery and postoperative complications;
The product can immediately relieve postoperative pain, effectively restore vertebral body height and correct spine kyphosis.
About the Balloon Kyphoplasty Procedure
Kyphoplasty is a minimally invasive procedure that stabilizes a fractured or compressed vertebra, reduces back pain, as well as restores height and spinal alignment. When a vertebra fractures, the usual rectangular shape of the bone becomes compressed and distorted, causing pain. These compression fractures, which may involve the collapse of one or more vertebrae in the spine, are a common symptom and result of osteoporosis. Osteoporosis is a disease that results in a loss of normal bone density, mass and strength, leading to a condition in which bones are increasingly porous or full of small holes and vulnerable to breaking. Vertebrae can also become weakened by cancer.
In Kyphoplasty, balloons are used to gently elevate the fractured vertebrae in an attempt to return it to the correct position. The balloon creates a void or a cavity that is then filled with a special cement to prevent further collapse. Kyphoplasty can be performed in patients who have severe pain requiring hospitalization or conditions that limit bed rest and medications.
Kyphoplasty is also performed on patients who:
Are too elderly or frail to tolerate open spinal surgery, or who have bones too weak for surgical spinal repair that have vertebral damage due to a malignant tumor
Are younger and have osteoporosis caused by long-term steroid treatment or a metabolic disorder
Kyphoplasty can increase the patient’s functional abilities, allow a return to the previous level of activity, and prevent further vertebral collapse. The procedure is usually successful at alleviating the pain caused by a compression fracture; many patients feel significant relief almost immediately. After just a few weeks, two-thirds of patients are able to lower their doses of pain medication significantly. Many patients become symptom-free. About 75 percent of patients regain lost mobility and become more active, which helps combat osteoporosis. After Kyphoplasty, patients who had been immobile can get out of bed, reducing their risk of pneumonia. Increased activity builds more muscle strength, further encouraging mobility. Usually, Kyphoplasty is a safe and effective procedure. No surgical incision is needed only a small nick in the skin that does not have to be stitched closed.
How to Prepare for Your Balloon Kyphoplasty Procedure:
A clinical evaluation including diagnostic imaging, blood tests, a physical exam, spine X-rays and a radioisotope bone scan or magnetic resonance (MR) imaging will be done to confirm the presence of a compression fracture that can be treated with kyphoplasty.
You should report to your doctor all medications that you are taking, including herbal supplements, and if you have any allergies, especially to anesthesia or to contrast materials (also known as “dye” or “X-ray dye”). Your physician may advise you to stop taking aspirin or a blood thinner for a specified period of time before your procedure
If you are diabetic, you should ask your doctor for instructions on taking your blood sugar medications.
In most cases, you may take your usual medications, especially blood pressure medications. These may be taken with some water in the morning before your procedure
You will need to have blood drawn and tested prior to the procedure to determine that your blood thinning medication has stopped working. If you are unable to stop taking this medication, a short inpatient stay for intravenous treatment with heparin may be required
During Your Balloon Kyphoplasty Procedure:
Image-guided minimally invasive procedures such as Kyphoplasty are most often performed by a specially trained interventional radiologist in an interventional radiology suite.
You will be admitted to the Same Day Surgery Unit and should plan to stay overnight
You will positioned lying face down for the procedure
You will connected to monitors that track your heart rate, blood pressure, and pulse during the procedure
A nurse will insert an intravenous (IV) line into a vein in your hand or arm so that sedat
