IFU Multilingual version PTCA balloon dilatation catheter.pdf

Demax Gusta PTCA Balloon Dilatation Catheter Has Received EU MDR Approval

Demax's independently developed and manufactured Gusta series balloon has recently received the CE certificate, in accordance with the European Union's Medical Device Regulation (MDR). This achievement comes after a thorough auditing process and signifies that the Gusta series balloon has successfully met all the necessary requirements, granting it access to the global market.

Demax is delighted to confirm the success of its Transitional Plan from MDD to MDR CE certification thus allowing its customers to maintain products availability.

Gusta PTCA Balloon Dilatation Catheter

Excellent crossability

1.Tapered head-end design,Small lesion entry profile

Tightly wrapped with guide wire to avoid fish-mouth phenomenon while ensuring traceability and crossability

2.Shorter tip length

Better ability to cross stenotic lesions

3.Embedded platinum-iridium alloy marker to reduce outer diameter loss

Improved crossability and precise positioning

Good pushability

1.Self-developed super smooth hydrophilic coating (invention patent)

Provides long-lasting lubrication for tracking and traversing lesions

2.Smooth guidewire exchange port with a smaller outer diameter 

For easier delivery and reduced intravascular resistance

3.Metal support shaft (hypotube) that tapers toward the distal end

Balancing support and flexibility to ensure the effective transfer of pushing force while avoiding bending

4.Ultra-thin proximal rod with a 1.9F outside diameter 

PTFE smooth coating，effectively reduces frictional resistance to the tube lumen

Gusta balloons have been recognized by many surgeons for their flexibility and passability in clinical applications. Surgeons expressed that Gusta balloons has performed well in procedures such as jailed balloon technique and balloon-stent kissing technique, and can be used when dealing with a variety of complex lesions such as CTO.

Since 2004, with the vision of producing high-quality medical devices, Demax has been committed to the R&D, production and sales of coronary artery intervention, neurointerventions and percutaneous peripheral interventions. Demax spans more than 90 countries and regions worldwide.

Now, Demax Gusta series balloons have won the highly challenging EU MDR certification, which proves Demax's excellent R&D and manufacturing capabilities and rigorous quality control system, and suggests that the safety and efficacy of Demax Gusta series balloons are internationally recognized and have the ability to be broadly internationalized.

In the future, we will take this as an opportunity to further develop and innovate, to bring more high-quality products to more countries, contributing to the global medical industry with higher standards, and benefiting more people's health.

We would like to take this opportunity to thank the interventional cardiologists, all the teams of caregivers and our distributors who trust Demax ,congratulations again and thanks to all Demax employees.