Hengsheng Medical's Next-Gen Self-Perfusing Drug-Coated Balloon Receives NMPA Acceptance

December 7, 2021,HENG SHENG MEDICAL's self-developed next-generation "self-perfusion drug-coated balloon" (DCAB) has officially received the acceptance notice from the National Medical Products Administration., will provide doctors and patients with better treatment solutions for coronary heart disease!

HENG SHENG MEDICAL Self-Infusion Drug-Coated Balloon

The concept of "intervention without implantation" has gained deep popularity, making drug-coated balloons a focal point of attention in the industry. However, existing conventional drug balloons can block blood flow for 30-60 seconds during the drug release process. Against this backdrop, HENG SHENG MEDICAL has adhered to independent innovation and developed a new generation of self-perfusion drug-coated balloons.

Compared with ordinary drug balloons on the market,New Generation Self-Perfusion Drug-Coated Balloon Ensures Normal Blood Flow During Surgical ExpansionNot only does it improve the patient's tolerance to surgery, but it also greatly reduces the incidence of adverse events, allowing the surgeon to use it with confidence and the patient to use it with peace of mind.

Early drug-coated balloons were developed to treat peripheral diseases, and these balloons need to be inflated for at least 180 seconds (3 minutes). According to pharmacokinetic explanations, 3 minutes of contact time is the optimal duration for drug release and can effectively repair vascular wall damage within this time.

When drug-coated balloons are used in coronary vessels, according to the "Chinese Expert Consensus on the Clinical Application of Drug-Coated Balloons": the diameter of the drug balloon should match the vessel diameter (reference diameter ratio of 0.8-1.0); it is recommended to maintain wall apposition expansion for 30-60 seconds; when expanding the drug balloon, use a nominal pressure of 7-8 atm.

When drug-coated balloons are used in coronary arteries, the vessel wall apposition time has decreased from 180 seconds to 30-60 seconds. This is because coronary arteries cannot withstand prolonged ischemia, which can lead to severe adverse events. This is also the reason why drug-coated balloons cannot be used in many coronary artery lesions.

HENG SHENG MEDICAL's New Generation Self-Infusion Drug-Coated Balloon Expands Indications (Dual Indications: Restenosis, Bifurcation Lesions), Expansion Process Does Not Interrupt Blood Flow,During human clinical trials, the dilation time can reach up to 5 minutes and is generally applicable., significantly increased the absorption ratio of vascular drugs and reduced vascular elastic recoil.

Common drug-coated balloons use dispersants to enhance drug adhesion during the drug spraying process, but this approach can reduce balloon deliverability and may cause severe allergic reactions in patients during the procedure.

HENG SHENG MEDICAL Self-Infusion Drug-Coated BalloonWithout using any dispersantsBy using the crystalline and amorphous forms of paclitaxel in multiple alternating spray coatings, it ensures the effective dose of paclitaxel reaches 3 μg/mm² while achieving precise controlled release, eliminating allergic reactions and enhancing balloon deliverability.

HENG SHENG MEDICAL, as a professional enterprise engaged in the research and production of cardiovascular interventional devices, is committed to innovation. It has pioneered the integration of next-generation self-perfusion technology with drug-coated balloons, opening a new chapter in the interventional treatment of coronary heart disease.