BIOHEART-B Receives NMPA Approval for its Bioresorbable Drug-Eluting Stent System

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The company has announced that on June 29, 2029, its independently developed Bioheart® Bioresorbable Drug-Eluting Stent (BRS) received approval from the National Medical Products Administration (NMPA) of China.

The stent is indicated for treating patients with ischemic heart disease caused by native coronary artery lesions, aiming to improve coronary artery lumen diameter.

Detailed results from the pivotal trial for the Bioheart® BRS have been published in JACC: Cardiovascular Interventions (Volume 18, Issue 1, 2025).

The Bioheart® system is the group's proprietary BRS system, specifically designed for percutaneous coronary intervention (PCI) to treat coronary artery disease.

Bioheart® is engineered to be fully absorbed by the body over time, temporarily maintaining vessel patency, effectively reducing elastic recoil and acute occlusion, while preventing restenosis.

The antiproliferative drug eluted from the stent inhibits neointimal hyperplasia, functioning equivalently to a drug-eluting stent (DES).

As vascular healing progresses and the need for mechanical radial support diminishes, the stent is gradually absorbed.

Consequently, Bioheart® facilitates true anatomical and functional "vascular restoration," as opposed to the implantation of a permanent foreign object.

Once fully absorbed, no foreign material remains within the vessel, perfectly embodying the clinical concepts of "leaving nothing behind" and "intervention without implantation."

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