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Industry Insights · Artificial Heart & Circulatory Support

China's artificial hearts: implantable + percutaneous, and how materials gatekeep

Heart failure is the end stage of cardiovascular disease — over 64M patients globally, 15M+ in China, 1.7M+ end-stage — while heart transplants number only ~1,000 a year, a vast donor gap. Ventricular assist devices (VADs) mechanically assist or replace the heart's pumping and are stretching from single end-stage therapy to full-course coverage. From a materials view serving medical devices, we care most about the floor: how materials gatekeep blood contact and long-term implantation.

2026-07-09BIO Industry Insights

China VAD landscape: implantable + percutaneous, full-course coverage, hemocompatibility
Artificial hearts span long-term end-stage support (implantable) to acute/high-risk short-term support (percutaneous), covering the full heart-failure course. Blood contact and long-term implantation are the core of materials-and-biocompatibility gatekeeping. Illustrative.
In short: China's artificial hearts are moving to an implantable-plus-percutaneous model. On the implantable side, five products are approved in China (four domestic: Core Medical, Tongxin, Aerospace Taixin, Yongrenxin, plus Abbott's HeartMate III); the percutaneous side was long empty until Core Medical's CorVad®4.0 became the first domestically approved percutaneous product in December 2025. Its implantable Corheart®6 pump is ~90 g and 34 mm, among the world's smallest and lightest, with >50% domestic share. The two are complementary, not competitive: implantable handles long-term end-stage support, while percutaneous covers short-term support for high-risk PCI and acute cardiogenic shock. In materials terms a VAD is a long-term blood-contact device, demanding rigorous hemocompatibility and anti-thrombus/hemolysis surface and flow-path design — and long-term clinical data remains the key challenge for domestic makers.

Why the field rose: the heart-failure imperative

The core tension in end-stage heart failure is that donors fall far short — only ~1,000 transplants a year against millions of end-stage patients. VADs mechanically assist or replace the heart's pumping as a core way to extend life, and have reached third-generation full-maglev technology, cutting blood damage and complications. That hard demand is the underlying reason the field took off.

The landscape: an implantable + percutaneous dual track

The two product types cover different stages of heart failure, complementary rather than substitutes:

  • Implantable (e.g. Corheart®6, 90 g/34 mm): long-term end-stage support/replacement; five products approved in China, with Core Medical taking share fast on miniaturisation;
  • Percutaneous (e.g. CorVad®4.0): transfemoral minimally invasive placement for short-term circulatory support in high-risk PCI and acute cardiogenic shock; Core Medical won the first domestic approval in December 2025, versus a global market previously led by J&J's Impella, leaving wide room for domestic substitution.

Materials view: gatekeeping long-term blood contact

The artificial heart is among the most demanding Class III devices for reliability and hemocompatibility: in long-term contact with blood, anti-thrombus and anti-hemolysis surfaces and flow paths, and long-term material stability, bear directly on safety. The industry's challenges concentrate here too — accumulating long-term clinical data, commercialisation and profitability pressure (leading players posted cumulative losses of several hundred million RMB over 2023–2025), payment and insurance coverage, and clinician/patient education. For material supply, the more long-term and blood-contacting the use, the more it demands biocompatibility data, lot traceability and complete documentation. BIO's role is to make the medical-grade materials line solid: selectable, documented, traceable.

The BIO angle

What matters in artificial hearts is not only how small the pump is, but reliability and biocompatibility under long-term blood contact. Materials, surfaces and documentation are the link that turns innovation into clinical safety — which is why BIO tracks materials for long-term implants.

FAQ

What is a VAD?

A ventricular assist device mechanically assists or replaces the heart's pumping; it is a core way to extend life in end-stage heart failure amid donor shortage, and has reached third-generation full-maglev technology.

What is the difference between implantable and percutaneous?

Implantable handles long-term end-stage support/replacement (e.g. Corheart®6); percutaneous is placed via the vasculature for short-term support in high-risk procedures and acute cardiogenic shock (e.g. CorVad®4.0), covering different stages of heart failure.

Why are materials so critical?

Artificial hearts contact blood long-term; anti-thrombus/hemolysis surfaces and flow paths, plus long-term material stability, bear directly on safety, making long-term clinical data and biocompatibility documentation the key challenge.

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Note: an original analysis compiled from public industry information; figures and conclusions per official/original sources. Not investment advice.

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