Product

Helios Sirolimus-eluting Coronary Stent With Biodegradable Polymer Technology

Effect time

Titanium-oxide coating

• Rutile structure: a long-term stable presence on the surface of the stent.
• Hemocompatibility: antithrombotic effect – reduces platelet and fibrinogen adhesion and activation.
• Tissue compatibility: inhibits inflammatory response, restores endothelial cell structure and function, and reduces metal ion release.

Titanium-oxide coating: 10-30nm.

PLGA: Thickness of lumen side 9-13μm, Thickness of wall side 15-19μm.

Co/Cr STRUT: Thickness 80μm.

Sirolimus: 135μg/cm².

Good biocompatibility makes perfect vascular endothelialization

Titanium-oxide coated stent animal experiment report

Scanning of electron microscopy

Two weeks after stent implantation, most of the titanium-oxide coated stent was basically covered by endothelium, while a large area of the non-titanium-oxide coated stent was not.

At 12 weeks of stent implantation, the endothelial cells on the titanium-oxide coated stent were elongated with a smooth surface, and regularly arranged along the long axis of the cells. The shape of the endothelial cells on the non-coated stent was oval with a large number of bumps on the surface, indicating that the endothelial cells on the stent with coating matured quickly and completed endothelial coverage and endothelial maturation rapidly.

Non-titanium-oxide coated stent

Tianium-oxide coated stent

The HOPE study

• Randomized controlled, multicenter prospective clinical study.
• 303 patients enrolled in 11 medical centers in China.

• First randomized controlled study of coronary stents in China.
• In terms of safety and efficacy, the Helios stent is not inferior to the control group.

Technology & Innovation

• Drug eluting stent in cobalt-chromium alloy with titanium-oxide coating.
• With completely independent intellectual property rights, we transfer the National Basic Research Program (973 program) ” The anti-coagulation and activation coating modification project for medical titanium alloy surface ” into industrial implementation, with more than 7 patent technologies in one single product.
• Application of the titanium-oxide coating in the cardiovascular field.
• First randomized controlled, multicenter prospective clinical study in China – the HOPE study.

SPECIFICATION