Balloon Forming Using Confluent Machines

Balloon forming is carried out using Confluent balloon forming machines, which employ precision blow molding in controlled molds. Heat and pressure are applied to extruded tubing to shape the balloon, followed by stretching to orient polymer chains and enhance strength, elasticity, and performance. This controlled process ensures uniform wall thickness, high dimensional accuracy, and reliable functional characteristics essential for stent delivery systems and catheters.

Bonding & Tipping Using Confluent Tube Welding Machines

Our Confluent tube welding machines enable precise bonding and tipping of catheters and balloons without adhesives. Balloons are fused directly to the outer and inner lumens, and the lumen is accurately welded to the hub tube. Special attention is given to the transition point weld, ensuring perfect alignment of the lumens, maintaining inner diameter, and guaranteeing smooth guidewire passage and fluid flow. This process ensures structural integrity, reliable performance, and consistent device quality.

Balloon Folding Using Folding Machines

Specialized balloon folding machines are used to precisely fold balloons for stent delivery systems and PTCA balloon Catheter. The balloon is partially collapsed using vacuum and mechanical compression to create a tri-fold configuration (three wings). It is then carefully wrapped around the catheter shaft, reducing the overall crossing profile and ensuring a compact, consistent, and reliable design for safe and effective delivery.

Stent Coating Process Using Spray Technology

Our stent coating process utilizes advanced spray technology to achieve precise and uniform application of polymer and drug layers on stents. This method ensures consistent coating thickness, excellent adhesion, and controlled drug release profiles.

Stent Crimping Using MSI Machines

We employ state-of-the-art MSI stent crimping machines to precisely mount stents onto balloon catheters. These systems ensure uniform radial compression, accurate positioning, and secure stent retention without damaging the balloon or coating. With programmable control of crimping force, diameter, and cycle steps, MSI technology provides superior repeatability and reliability. This enables us to achieve tight dimensional tolerances and consistent product performance, meeting the highest quality and regulatory standards.

Ethylene Oxide (ETO) sterilization

Ensuring complete microbial inactivation while preserving the functionality, material integrity, and performance of the sterilized medical devices. The process is compliant with ISO 11135:2014.

Medical-grade materials certified packaging validated as per ISO 11607-1 & ISO 11607-2

• Maintains sterility until point of use
• Puncture-resistant and durable
• Compatible with standard sterilization methods (ETO)
• Easy-peel opening for convenient handling
• protect device integrity during handling, storage, and transportation

At Vasmed Technologies, we ensure every catheter and stent meets the highest standards of safety, performance, and reliability. All tests are performed in accordance with ISO 10555, ISO 25539, and ISO 10993 standards

Catheter Testing

Our PTCA catheters undergo rigorous mechanical evaluations to ensure superior clinical performance:

• Tensile & Bond Strength – Confirms structural integrity under pull forces.
• Burst & Leak Pressure – Ensures lumen and balloon integrity under pressure.
• Flexibility & Kink Resistance – Verifies smooth navigation through tortuous anatomy.
• Pushability, Trackability & Torquability – Confirms precise control and delivery.
• Dimensional Accuracy & Flow – Ensures compatibility with guidewires and consistent fluid delivery.

Stent Testing

All stent systems are tested as per ISO 25539 for mechanical reliability:

• Stent Retention & Radial Force – Ensures secure mounting and vessel support.
• Foreshortening & Recoil – Verifies accurate expansion and dimensional stability.
• RBP & Flexibility Tests – Confirms safe balloon inflation and smooth delivery.
• Trackability & Crossability – Ensures ease of navigation through complex vessels.

Drug-Eluting Stent (DES) Testing

Our DES undergo comprehensive drug evaluations to ensure controlled and consistent therapeutic delivery:

• Drug Content & Assay – Validates correct dosage and purity.
• Drug Release (Elution) – Confirms sustained, predictable release under physiological conditions.

Shelf-Life Studies

Both Accelerated and Real-Time Aging studies (ASTM F1980, ISO 11607-1) verify long-term product safety and performance.

Biocompatibility

All Vasmed products are tested per ISO 10993 for biological safety, including:

• Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Genotoxicity, and Hemocompatibility.

These evaluations ensure full compatibility and patient safety during clinical use.

• High-Performance Liquid Chromatography (HPLC) used to verify drug content, coating uniformity, and release characteristics
• Hydrostatic Burst and Leak Testing (HBLT) confirms balloon strength, pressure resistance, and leak-free functionality
• In addition, packaging integrity, sterility assurance, and labelling accuracy are thoroughly verified, ensuring complete compliance with regulatory requirements and patient safety.