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The Disposable PTCA Cardiovascular Surgery Balloon Inflation Device

The PTCA Cardiovascular Surgery Balloon Inflation Device is a core supporting instrument for Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Coronary Intervention (PCI). It is specially designed for precise inflation, pressure maintenance and deflation of balloon catheters. Adopting an ergonomic integrated structure, it is equipped with a high-precision pressure gauge and safety locking device to monitor and stably adjust internal balloon pressure in real time, so as to accurately complete vascular dilatation and stent apposition during operations. The device is fitted with a kink-resistant extension tube and standard Luer connector, compatible with mainstream coronary and peripheral vascular balloon catheters. As a disposable sterile device, it features simple one-hand operation for inflation and deflation, effectively reducing cross-infection risks. With high pressure control accuracy and comprehensive safety protection, it is widely used in minimally invasive cardiovascular interventional procedures in cardiology and interventional departments, and serves as an essential basic device in catheterization labs.

  • Intended Use :

    PCI
  • Standard Volume :

    20ml / 25ml / 30ml
  • Maximum Output Pressure :

    Standard: 30atm; High-pressure: 40atm
  • Shelf Life :

    3 years
  • Sterilization :

    EO
  • Usage Type :

    Single Use Only

Product Overview

Developed to meet clinical demands of cardiovascular interventional procedures, this PTCA Balloon Inflation device mainly consists of pump body, plunger rod, high-precision pressure gauge, safety locking valve, deflation button and kink-resistant extension tube. The pump body is made of medical high-strength transparent polypropylene, which is pressure-resistant and leak-proof, allowing direct observation of contrast medium or saline volume. The pressure gauge with fluorescent scales ensures clear reading even in dim operating environments. Its pressure range covers commonly used clinical values, adapting to conventional balloons, non-compliant balloons, drug-coated balloons and other types of interventional balloons. The ergonomic handle enables smooth and labor-saving pushing, pulling and rotating. The mechanical safety lock can fix the target pressure and prevent abnormal pressure fluctuation during operations. The flexible extension tube made of medical polymer features excellent kink resistance and tight sealing. Standard Luer connectors at both ends ensure stable connection and easy assembly. Available in standard and high-pressure models, the maximum output pressure reaches 30atm or 40atm, with volumes of 20ml, 25ml and 30ml for selection. Sterilized by ethylene oxide and designed for single use, it eliminates re-sterilization work, simplifies preoperative preparation and greatly improves surgical efficiency and clinical safety.


Key Highlights

  • Accurate Pressure Monitoring: The high-precision pressure gauge with fluorescent scales delivers intuitive reading and sensitive pressure feedback to ensure precise pressure regulation.
  • Ergonomic Design: The streamlined integrated handle supports one-hand operation for inflation, pressure maintenance and deflation, reducing fatigue during long procedures.
  • Multiple Safety Protection: Built-in pressure lock and one-click deflation button can fix preset pressure and release pressure rapidly in emergencies, preventing balloon rupture caused by overpressure.
  • Pressure Resistance & Leak-proof Performance: The high-strength medical pump body and sealed piston structure feature excellent pressure resistance and zero leakage, suitable for high-pressure dilatation procedures.
  • Kink-resistant Extension Tube: The matched flexible tube remains unobstructed under torsion and bending to avoid pressure transmission failure.
  • Wide Compatibility: Universal standard Luer connector is compatible with most domestic and overseas coronary and peripheral vascular balloon catheters.
  • Diversified Specifications: Multiple volumes and pressure grades are available to adapt to pre-dilatation, post-dilatation and stent apposition procedures.
  • Disposable Sterile Design: Individually sterile packaged to avoid cross-infection. No cleaning or re-sterilization is required, simplifying consumable management in catheterization labs.

Technical Specifications & Construction

The complete kit consists of outer sheath, tapered dilator, hemostatic valve, three-way stopcock, puncture needle and guide wire. Skin scalpel is optional for selected models. The shaft adopts three-layer composite structure with full distal hydrophilic coating. The entire shaft is equipped with radiopaque materials and platinum-iridium markers. Outer diameter is measured in French (Fr) with mainstream clinical sizes and multiple standard lengths. Sterilized by ethylene oxide, the device is individually packed in sterile pouch for single use.

Standard Volume 20ml / 25ml / 30ml
Maximum Output Pressure Standard: 30atm; High-pressure: 40atm
Safety Configuration Mechanical pressure lock valve + One-click rapid deflation button
Usage Single Use Only



Typical Clinical Applications

As a dedicated auxiliary device for cardiovascular intervention, this product is mainly used in cardiology, interventional departments and vascular surgery for minimally invasive procedures via radial or femoral artery approaches:

  • Balloon inflation and deflation for Percutaneous Transluminal Coronary Angioplasty (PTCA)
  • Pre-dilatation, post-dilatation and precise stent apposition during Percutaneous Coronary Intervention (PCI)
  • Balloon pressurization for interventional treatment of coronary chronic total occlusions (CTO)
  • Clinical application of special functional balloons including drug-coated balloons, non-compliant balloons and scoring balloons
  • Balloon angioplasty for peripheral arterial stenosis
  • Temporary pressure maintenance and repeated balloon inflation/deflation during operations
  • Auxiliary pressurization and pipeline pressure monitoring in various cardiovascular interventional procedures

Quality Assurance & Compliance

Patient safety and clinical efficacy are our top priorities. The PTCA Cardiovascular Surgery Balloon Inflation Device is manufactured in Class 10,000 standardized cleanrooms in strict accordance with the ISO 13485 medical device quality management system. Every batch undergoes rigorous tests including pressure resistance test, tightness test, pressure gauge accuracy calibration, tube kink resistance test, biocompatibility test and sterility test to ensure accurate pressure control, reliable sealing and smooth operation. The product has obtained multiple international authoritative certifications such as EU CE and US FDA, complying with global safety standards for interventional medical devices. Complete registration and compliance documents are available to meet market access requirements of hospitals, specialized clinics and medical device distributors worldwide.


Ordering Information

We supply a full range of PTCA balloon inflation devices to hospitals, interventional departments and medical device distributors worldwide. Combined-spec bulk orders are accepted. Custom tube lengths, dial markings and exclusive packaging solutions are available upon request, together with OEM/ODM services. Please contact our sales team for wholesale pricing, shipping terms, lead time and regional compliance certification documents.


Frequently Asked Questions (FAQ)

1. What is the maximum working pressure of this balloon inflation device?

This product has two models. The standard model provides a maximum output pressure of 30atm for conventional balloons and drug-coated balloons. The high-pressure model reaches 40atm, which is mainly used for non-compliant balloons and procedures for calcified lesions requiring high pressure.

 

2. Can this inflation device be re-sterilized and reused?

No. This is a single-use sterile medical device. Re-sterilization and reuse will cause aging of seals, reduced accuracy of pressure gauge and tube damage, leading to leakage, pressure out of control and cross-infection. Reuse is strictly prohibited to ensure patient safety and surgical accuracy.

 

3. Do you support global shipping and bulk orders?

Absolutely. We cooperate with professional international logistics providers to fulfill global B2B bulk orders. Custom tube lengths, product markings and packaging styles are available, along with complete compliance documents. Please inform us of your required specifications and quantity, and we will deliver a customized quote and estimated lead time.

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