Next-Generation Benchmark in Lower-Limb Stent Therapy: BioStealth™
Clinical Focus
LEAD and CLTI Affecting Over 200 Million People
Lower Extremity Artery Disease (LEAD) is a serious social issue affecting over 200 million people worldwide in our aging society. When this disease progresses to "Chronic Limb-Threatening Ischemia (CLTI)," accompanied by rest pain and non-healing ulcers, patients face an extremely high risk of lower limb amputation.
Treatment of arteriosclerosis in the BTK region is extremely difficult.
Currently, conventional PTA (balloon angioplasty) is the mainstream treatment for BTK, but reports indicate a restenosis rate of 73% within 3 months post-surgery, making the maintenance of long-term patency a significant issue.
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Challenges of DES (Drug-Eluting Stents): In small-diameter BTK vessels with slow blood flow, the permanent implantation of a stent as a "foreign body" carries risks of chronic inflammation and thrombus formation.
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Challenges of DCB (Drug-Coated Balloons): For cases with vascular dissection or severe calcification, balloon-only treatment lacking physical scaffolding makes it difficult to achieve both sufficient initial success and long-term patency.
A new answer to the history of stent therapy: BioStealth™.
A Paradigm Shift in Design Philosophy
From “Leave Nothing Behind” to “Leave the Right Thing Behind”
The history of endovascular stenting began in the 1990s with bare-metal stents (BMS) designed to mechanically maintain vessel patency.
Subsequent challenges—namely thrombosis and smooth muscle cell hyperplasia leading to in-stent restenosis—drove the evolution toward dual antiplatelet therapy (DAPT) and drug-eluting stents (DES).
More recently, particularly in the superficial femoral artery (SFA), the concept of “Leave Nothing Behind (LNB)” has gained popularity, with drug-coated balloons positioned as an ideal solution.
However, in lesions where mechanical support is essential, we believe the next step lies beyond LNB.
Providing physical scaffolding while remaining as biologically compatible as possible—
leaving behind only the “Right” thing, in the Right form.
This is the next-generation standard pursued by Global Vascular:
“Leave the Right Thing Behind.”
The Concept of Merging Biocompatibility and Physical Support brought by BioStealth™
We propose a new design philosophy that advances the concept of "Leave Nothing Behind" to "Leave the 'Right' thing behind." At the core of this is our proprietary biomaterial technology, BioStealth™.
Three Core Technologies of BioStealth™
BioGradia™ Technology
Pursuing both high antithrombogenicity and endothelial cell affinity through proprietary coating technology. By suppressing platelet and thrombus adhesion and promoting early endothelialization, this technology aims to maintain a healthy vessel lumen after stent implantation.
Designed to elute drugs over several months to suppress smooth muscle cell hyperproliferation in the acute phase. After the polymer gradually disappears, the outermost surface transitions to the diamond nano-coating, ensuring long-term biocompatibility.
Combines flexible conformability to the complex deformations unique to the lower limb region with sufficient radial force to support the vessel. The ultra-thin design aims to minimize impact on blood flow, contributing to the maintenance of ideal hemodynamics.
BioDiamond™ Technology Promoting antithrombogenicity and endothelialization via diamond nano-coating
BioGradia™ Technology Drug-eluting layer using bioresorbable polymer and Sirolimus
ThinForce™ Technology
ThinForce™ Technology A platform combining thin struts (120µm) and high radial force
BioDiamond™ Technology
Project
BioStealth™ Stent for BTK (Below-the-Knee)
Following fundamental and applied research continuing since the 2000s, we have completed proof of concept and detailed design. We completed major non-clinical studies in Japan and the US in 2024, and as of 2026, we are conducting clinical trials at medical institutions including Tokai University School of Medicine.
BioStealth™ Stent for SFA (Superficial Femoral Artery)
BioStealth™ Stent for BTK (Below-the-Knee)
Our BioStealth™ Stent
*The technologies and products described on this page are currently under development and have not received approval under the PMD Act in Japan. The content is based on development philosophy and research-stage data, and does not guarantee future clinical efficacy.