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BriefMEDTECH

Fully Biodegradable Vascular Stent ScaffoldPro Completes 500 Clinical Implants: Metal Stent Era May Be Ending

MicroPort Medical's fully biodegradable vascular stent ScaffoldPro completed its 500th clinical implant. Made of polylactic acid material, the stent completely degrades into water and carbon dioxide within 2 years, restoring natural vessel pulsation. Clinical follow-up shows restenosis rates comparable to metal drug-eluting stents.

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MicroPort Medical announced on May 14 that its independently developed fully biodegradable vascular stent ScaffoldPro has completed its 500th clinical implant. Made of polylactic acid (PLLA) material with antiproliferative drug coating, the stent gradually degrades into water and carbon dioxide within 2 years after coronary artery implantation, ultimately being fully absorbed by the body.

Traditional metal drug-eluting stents (DES) permanently remain in blood vessels once implanted, restricting natural vessel pulsation and requiring patients to take long-term antiplatelet medication. ScaffoldPro's design philosophy is to "retire" after supporting vessel healing, allowing blood vessels to resume normal physiological function.

In 18-month follow-up data, ScaffoldPro's target lesion restenosis rate was 4.8%, at the same level as mainstream metal drug-eluting stents (4-6%). MicroPort coronary R&D vice president Luo Qiyi said: "ScaffoldPro proves that fully biodegradable stents can match metal stents in clinical effectiveness. The next step is long-term followview data and larger-scale clinical trials."

The product has received NMPA innovative medical device special approval channel qualification in China, with market approval expected in the first half of 2029.