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Cardiovascular interventional Pebax Semi Compliance Balloon Dilatation Catheter FDA

PTCA balloon catheter is mainly used to dilate patients' stenosis of coronary artery lesions and improve myocardial blood flow through minimally invasive interventional surgery (PCI).  It can also be used to deliver release stents to patients with coronary artery stenosis.
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Products introduction: 


Introducing our PTCA Balloon Dilatation Catheter, a specialized medical device designed for cardiovascular interventional procedures. This catheter is a cutting-edge solution engineered to meet the unique demands of these interventions, providing essential tools for medical professionals in the field of cardiology.


Designed with precision and advanced technology, our PTCA Balloon Dilatation Catheter ensures optimal performance in dilating stenotic vessels within the cardiovascular system. It's specifically crafted to assist healthcare practitioners in Percutaneous Transluminal Coronary Angioplasty (PTCA), a vital procedure for treating coronary artery diseases and enhancing blood flow.


With a focus on reliability and efficiency, our catheter boasts key features such as enhanced delivery performance, facilitated by a tapered core wire and advanced laser bonding technology. Additionally, the super-lubricity hydrophilic coating contributes to seamless catheter movement during the procedure.


The 3-wing balloon fluting design ensures a minimal balloon profile, easing the passage through stenotic regions, while the tip laser forming technology creates a small entrance, further optimizing crossability performance. The soft tapered tip adds to the catheter's trackability, allowing for precise navigation within the cardiovascular system with the use of a guidewire.


Rest assured, our PTCA Balloon Dilatation Catheter adheres to the highest quality standards and is backed by extensive clinical testing, making it a trusted tool for cardiovascular interventions worldwide. Choose our catheter for superior performance and reliability in delivering optimal outcomes for your patients.



Product Features:

1. Enhanced Delivery Precision:** The carefully designed tapered core wire ensures exceptional delivery precision, facilitating optimal placement within the target area.


2. Unparalleled Lubrication:** Our catheter features a super-lubricity hydrophilic coating, elevating delivery performance to superior levels, enabling smoother navigation through vascular pathways.


3. Streamlined Stenosis Crossing:** The innovative 3-wings balloon fluting design minimizes the balloon's profile, simplifying its passage through stenotic regions, leading to improved ease and efficiency.


4. Seamless Transition:** Employing advanced laser bonding technology, we ensure a seamless transition between the balloon and catheter, resulting in outstanding crossability, minimizing obstructions during the procedure.


5. **Precision Engineering:** The tip laser forming technology creates a balloon with a small entrance, enhancing crossability performance. Moreover, the soft tapered tip is meticulously designed to enhance catheter trackability when used with a guidewire.



What are the precautions when using PTCA balloon catheter expansion?  

1. Use PTCA balloon dilatation catheter prior to the "use life" specified on the package.  

2. Before angioplasty, check the integrity of the catheter to ensure that the size and shape of the PTCA balloon dilator catheter is appropriate for the specific procedure.  

3. Please check all products before use.  Do not use the package if it is opened or damaged, or if there is any indication that the product is damaged.  

4. PTCA balloon catheters should only be used by physicians trained in percutaneous endoplasty.  

5. Patients must use appropriate anticoagulants and coronary vasodilators throughout treatment.  Go through the formalities as needed.  Medication should be continued for a period of time until deemed appropriate by the doctor.  

6. Provide adequate support for the shaft segment while reinstalling the catheter on the guide wire.  


Balloon Compliance and Rated Burst Pressure:

P/atm D/mmTolerance of Compliance:±5%
6 (NP)810121416 (RBP)18
1.51.501.531.561.591.621.651.68
2.02.002.032.062.092.122.152.18
2.52.502.542.582.612.642.672.70
2.752.752.792.832.862.892.922.95
3.03.003.043.083.113.143.173.21
3.53.503.553.603.643.693.733.77
4.04.004.054.104.154.204.254.30

Size Matrix of PTCA Balloon Catheter:

L/mm
D/mm
10152025303540
1.5---
2.0--
2.5
2.75
3.0
3.5
4.0




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