Huihe Healthcare's Vispearl®, the World's First Fully Radiopaque Drug-Eluting Microsphere, Receives NMPA Approval
H&H Healthcare
R&D and Producer of Interventional Medical Devices for Heart Disease
March 25, 2024, HuiHe HealthcareVispearl®World's First Full-Size Visible Drug-Eluting Microsphere, obtaining the marketing approval from the National Medical Products Administration (NMPA) of China (Registration Certificate for Medical Devices20243130560）。
HuiHe HealthcareVispearl®YesGlobal FirstFull-size visible drug-loaded microspheres, showcasing the R&D potential of China's medical industry, also marks another solid step forward for the "Healthy China 2030" plan.。Vispearl®Will bring the best treatment options for tumor intervention through highly competitive pricing and excellent quality.
Vispearl®Visible Drug-Loaded Microspheres Are Suitable for Embolization Therapy of Hypervascular Solid Organ Malignant Tumors.
In recent years, with the gradual深入人心 of the concept of fine embolization, the usage of small-caliber and ultra-small-caliber embolic agents has been increasing. However, in clinical practice, the only embolic agent that can meet this caliber requirement is the traditional Lipiodol emulsion, which also has various problems such as poor stability, insufficient embolic density, not being a permanent embolic agent, and serious postoperative adverse reactions. Meanwhile, the commonly used microsphere embolic agents currently cannot meet the requirements for peripheral embolization.
In order to better address the aforementioned clinical pain points, HuiHe Healthcare has developed Vispearl.®Visible Drug-Loaded Microspheres. These microspheres are based on traditional drug-loaded microspheres, throughPatented Iodine-Containing Contrast Molecule (Triiodobenzoic Acid) with Critical Phase Interface Cross-Linking Process, producing this globally unique full-size visible drug-loaded microsphere. At the same timeSolved the pain points of traditional microspheres being too large for peripheral embolization and non-imaging post-operation.These optimizations enable the concept of precise embolization to better benefit a wide range of patients.
HuiHe Healthcare will launch a trial program for visible microspheres soon. Interested doctors can contact us via the backend to discuss the specific trial process.
Director of the Interventional Department at Zhongshan Hospital, Fudan University,Professor, Ph.D. studentMentor
Deputy Director of the National Clinical Research Center for Radiology and Treatment
Vispearl®Chief Investigator of Visible Microspheres
Warm congratulations to Vispearl®Visible Drug-Loaded Microspheres Officially Launched!
The smallest specification of this microsphere is 40 microns, meeting our clinical need for distal "precise embolization." The advancements in embolic agents and microcatheters have allowed our generation of interventional physicians to experience a rapid evolution in TACE technology, and precise embolization can significantly reduce the impact on normal tissues.As we all know, there are no safe embolic agents, only embolic agents that are used safely.Embolization agents with a particle size of 40μm can further ensure the efficacy and bring our TACE treatment for liver cancer to a new level.
Manager of HuiHe Healthcare Biochemical R&D Department
State Key Laboratory of Molecular Engineering of Polymers, Department of Chemistry, Fudan University, Postdoctoral Station
Very honored Vispearl®Recognized by the National Medical Products Administration and numerous experts!
Vispearl®It is the abbreviation of Visible Pearl, a visible drug-loaded microsphere with completely independent intellectual property rights and domestically首创 in China.
A high-quality pearl takes at least three years to form; it has been over three years since I led the team to develop Vispearl®. We firmly believe that this "jewel" of HuiHe Healthcare can bring more certainty and better outcomes for doctors and patients. To develop more user-friendly and cost-effective medical devices, our efforts have never ceased.
Professor Gaojun Teng
Academician of the Chinese Academy of Sciences,Professor, Ph.D.,Ph.D. Supervisor,
President of Zhongda Hospital, Southeast University, and Director of the Intervention Center.
First of all, warm congratulations on the first visible drug-loaded microsphere Vispearl in China®Officially Launched!
TACE therapy is a recommended treatment in the guidelines for liver cancer. We are in an era of technological explosion, and interventional treatment for liver cancer has undergone several generations of technological changes. From the earliest arterial infusion chemotherapy, to the use of lipiodol embolization, and later to drug-eluting beads embolization and radioactive microsphere embolization.Today, we are very pleased to welcome the arrival of the visible drug-loaded microspheres, marking the transition of liver cancer embolization treatment into the visible stage. This will greatly enhance the safety and effectiveness of TACE treatment. I am very much looking forward to Vispearl.®Performance in all aspects after listing.
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question@hh-healthcare.com
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