Changmei Medtech

Kyphoplasty System Products

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.        


  • 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.

Kyphoplasty System Products List (8G)

No. Name Model Qty.
1 Kyphoplasty Balloon Catheter KB0210/KB0115/KB0120 1
2 Balloon Inflator BI-20A-10 1
3 Kyphoplasty Tool Kit KT-00-01/KT-00-02/KT-00-03/KT-00-04 1


Kyphoplasty Tool Kit List (8G)

No. Name Model KT-00-01 KT-00-02 KT-00-03 KT-00-04
1 Puncture device KT-01-01 2 2 1 1
2 Puncture & Expandor device KT-02-01 1 / 1 /
3 Expandor device KT-03-01 2 2 1 1
4 Bone drill KT-05-01 1 1 1 1
5 Guide wire KT-06-01 2 3 1 1
6 Bone cement filling device KT-04-01 6 6 3 3


Kyphoplasty System Products List (11G)

No. Name Model Qty.
1 Kyphoplasty Balloon Catheter KB0210S/KB0115S/KB0120S 1
2 Balloon Inflator BI-20A-10 1
3 Kyphoplasty Tool Kit KT-00-05/KT-00-06 1


Kyphoplasty Tool Kit List (11G)

No. Name Model KT-00-05 KT-00-06
1 Puncture & Expandor device KT-07-01 2 1
2 Bone cement filling device KT-08-01 6 1
3 Bone drill KT-09-01 1 1

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 sedative medication can be given intravenously
  • You may also receive general anesthesia
  • You may be given an antibiotic to help prevent infection
  • The area where the hollow needle will be inserted will be shaved, sterilized and covered with a surgical drape
  • A local anesthetic will be injected into the muscles near the site of the fracture
  • A very small nick is made in the skin at the site
  • Using X-ray guidance, a hollow needle called a trocar is passed through the spinal muscles until its tip is precisely positioned within the fractured vertebra. Once the needle is in the proper location, a balloon is inflated to raise the vertebra, orthopedic cement is injected into this cavity. Medical-grade cement hardens quickly, within 20 minutes
  • A CT-scan may be performed at the end of the procedure to check the distribution of the cement
  • You will remain in the recovery room for approximately an hour following the procedure
  • This procedure is usually completed within two hours. The procedure will take longer if more than one site is being treated

After Your Balloon Kyphoplasty Procedure:
Bed rest is recommended for the first 24 hours following Kyphoplasty, though you may get up to use the bathroom. Increase your activity gradually, walking will help build muscles and will become easier. For two or three days afterward, you may feel a bit sore at the point of the needle insertion. You can use an icepack to relieve any discomfort but be sure to protect your skin from the ice with a cloth and ice the area for only 15 minutes per hour. Your band-aid should remain in place for 2 days.

  • Do not bend during the first week
  • Do not participate in Physical Therapy for one month
  • Do not lift greater than 15 pounds for one month
  • You may shower the day after the procedure, but be careful
  • Do not take a bath for 5 days
  • Do not enter a Jacuzzi for 10 days

Potential Complications:
Any procedure where the skin is penetrated carries a risk of infection. The chance of infection requiring antibiotic treatment appears to be less than 1 in 1,000. A small amount of orthopedic cement can leak out of the vertebral body. This does not usually cause a serious problem, unless the leakage moves into a potentially dangerous location such as the spinal canal. Other possible complications include infection, bleeding, increased back pain and neurological symptoms such as numbness and tingling. Paralysis is extremely rare. Sometimes the procedure causes another fracture in the spine or ribs.

Read 42962 times Last modified on Thursday, 16 May 2024 12:53