Kyphoplasty System Products

Your Professional Kyphoplasty System Products Supplier！

Jiangsu Changmei Medtech Co., Ltd. was founded in 2013 and specializes in the design, research, and production of all kinds of minimally invasive medical devices, with a particular focus on the kyphoplasty system products, dilation balloon catheter products, and endoscopic products, which are all CE certificated, we have a comprehensive strength from the original design, development to batch production.

Our Factory

We have a modern standard factory building of 6,800 square meters and a GMP standard 100,000-level clean workshop of 2,000 square meters. and also have good cooperation relationships with customers all over the world, including the member companies of Stryker and Medtronic.

Professional Team

Our team members have experience and background in different industries in enterprise processes and applications. We cultivate our team with professionalism and pursuit of perfection. Through nearly 10 years of effort, the kyphoplasty balloon catheter already accounts for 80% of the Chinese market.

Our Certificate

Our National Class II and Class III medical device production license;CE, ISO13485; Kyphoplasty System Products have obtained CE MDR Certificate and FDA Approval.

Quality Control

We possess well-established production lines for raw materials, components, and finished products, enabling strict control from the source to the final output. This integrated production model not only guarantees the high quality and stability of our products but also allows us to quickly respond to market demands and continuously innovate.

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Kyphoplasty System Products

Kyphoplasty system products are medical devices used in a minimally invasive procedure called kyphoplasty, which treats vertebral compression fractures (VCFs) by restoring vertebral body height and stabilizing the spine. These systems typically include specialized instruments for accessing the vertebra, inflating a balloon to create space, and injecting bone cement to stabilize the fracture.

Product Specification

We provide the following product introduce specifications

Model	Distance of Two	Channel ID	Overall Length	Maximum Volume	Constrained Burst	SizeType
Model	Radiopaque Makers	Channel ID	Overall Length	Maximum Volume	Pressure	SizeType
KB0210	10	≥3.65mm	315mm	4cc	≥400 PSI	8G
KB0115	15	≥3.65mm	315mm	4cc	≥400 PSI	8G
KB0120	20	≥3.65mm	315mm	6cc	≥400 PSI	8G
KB0210S1	10	≥3.10mm	280mm	3cc	≥400 PSI	11G
KB0115S1	15	≥3.10mm	280mm	4cc	≥400 PSI	11G
KB0120S1	20	≥3.10mm	280mm	6cc	≥400 PSI	11G

Common types

We provide the following product introduce

PKP Balloon Catheter

This device is mainly used in percutaneous kyphoplasty (pkp) operation to dilate vertebral body and form a cavum which is for injecting bone cement to recover and stabilize vertebral body.

PKP Tool Kit

This device is mainly used for bone percutaneous intervention and establishing working channel by medical institutions.Minimally invasive surgery can reduce tissue injury and blood loss.The operation is simple, fast,and the operation time greatly shortened.

PKP Balloon Inflation Device

This device is mainly used for hydraulic pressure on balloons to achieve the function of balloon dilation.Optimal head fluid channel design makes it convenient for venting.O-type plunger design makes for low frictional resistance and can pressure easily.

Vertebral Balloon Catheters

This device is mainly used in percutaneous kyphoplasty (pkp) operation to dilate vertebral body and form a cavum which is for injecting bone cement to recover and stabilize vertebral body.

Types of PKP Balloon Catheters

Single-Lumen vs. Double-Lumen Catheters

Single-lumen catheters have one channel for delivering fluids. Double-lumen catheters have two channels for different substances. This makes double-lumen catheters more flexible but harder to use.

Single-lumen catheters work best for simple procedures needing one fluid. They are easy to insert and have a lower infection risk.Double-lumen catheters are used for complex treatments needing multiple fluids. These are common in intensive care or advanced medical cases.

High-Pressure vs. Low-Pressure Balloon Catheters

High-pressure catheters are used when strong force is needed. They help fix severe bone problems or restore bone height. Studies like ISAR-CALC show they work well in tough cases.

Low-pressure catheters are safer for weak or fragile bones. They lower risks like balloon bursts or cement leaks. These catheters are easier to control and good for delicate fractures.

Applications Of Balloon Catheters In Medical Procedures

Fixing Spine Height

Balloon catheters help fix the height of crushed bones. When the balloon inflates, it lifts the bone back up. This helps fix posture and reduces pressure on nearby tissues.

Easing Pain from Broken Bones

These catheters make broken bones stable, which eases pain. Many patients feel better right after the procedure. This makes these tools very helpful for spine injuries.

Target Group

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.

OEM Medical Balloon

We specializes in the development and design of medical devices, with a particular focus on medical balloon research and production. We can provide integrated solutions of balloon and catheter related products as well as full-set production equipment according to customer requirements.

Material	PA, PEBAX, PU
Brand	Lubrizol, Arekma, Evonik
Production Environment	100 000 Class Clean Room
Main Equipments	2 Balloon Tube Extrusion line, 5 Balloon Neck Forming Machine, 12 Balloon Forming Machine, other equipments such as Balloon Welding Machine, Rediopaque Swaging Machine, Balloon Pleating Machine, Balloon High Pressure Seal Tester, Tip Forming Machine

Certifications

FAQ

Q: What is the capacity of the balloon in a catheter?

A: Larger balloons (30 cc – 60 cc) are generally used to facilitate drainage or provide hemostasis when necessary, especially in the postoperative period. The balloon of the catheter usually sits at the base of the bladder, obstructing the internal urethral orifice.

Q: What material is used for balloon catheters?

A: Nylons, PET, polyurethanes, and polyolefins (HDPE) are most often used in the manufacture of balloon catheters. One material property that is important in the application of balloons is compliance. Balloon compliance is the term used to describe the degree to which balloon's diameter changes as a function of pressure.

Q: What is the normal volume of a catheter balloon?

A: The balloon at the tip of the catheter, used to hold it in place inside the bladder, varies in size. Common Foley catheter balloon sizes include 5 ml, 10 ml, and 30 ml. The choice of balloon size depends on the duration of catheterization and patient needs.

Q: How many cc to inflate a catheter balloon?

A: Assure catheter balloon is positioned well-within the patient's bladder. Completely inflate 5cc balloon with the volume prescibed on the package using the entire 10cc of sterile water provided. Balloon should be inflated slowly with a gentle, constant force.

Q: What is the inflation device for balloon dilation?

A: Balloon Inflation Device BID1 Type. This medical balloon inflation device is used in PTCA operation to pressurize the balloon dilatation catheter, inflate and contract the balloon accurately, so as to achieve the purpose of dilating blood vessels or indwelling stents in blood vessels.

Q: What are inflation devices used for?

A: These devices are essential in various radiological interventions, such as angiography and angioplasty. Inflation devices are used to inflate balloons and catheters, allowing for precise positioning and optimal visualization of blood vessels during the procedure.

Q: What is the goal for medical contact to balloon inflation time for PCI?

A: 90 Minutes
Guidelines recommend that the interval between arrival at the hospital and intracoronary balloon inflation (door-to-balloon (D2B) time) during primary PCI should be 90 minutes or less. The earlier therapy is initiated, the better the outcome.

We're well-known as one of the leading kyphoplasty system products manufacturers and suppliers in China. Please feel free to buy customized kyphoplasty system products made in China here from our factory. Contact us for pricelist.