Innovative Chinese Medtech Firm CH Biomedical Achieves Historic Milestone with First U.S. Implant of BrioVAD® in INNOVATE Clinical Trial

Nov 30, 2024 17:37 CST Updated 17:37

BrioHealth Solutions

Ventricular Assist Device Developer and Manufacturer

Recently

BrioHealth Solutions Announces Its Self-Developed

Fully Magnetically Levitated Left Ventricular Assist DeviceBrioVAD^®

At Emory University Hospital in the United States

Completed the INNOVATE Clinical TrialFirst CasePatient Enrollment

This milestone marks BrioHealth Solutions

Major Breakthrough Achieved in Global Heart Failure Treatment

This also demonstrates China's international competitiveness in the field of artificial hearts.

Dr. Chen Chen, founder of BrioHealth Solutions, stated: "We are launching the INNOVATE clinical trial with extraordinary excitement. After a long journey of continuous innovation, refinement, and quality optimization, we have empoweredBrioVAD^®Life." Despite advancements in the field of ventricular assist devices, there remains an urgent need to enhance device performance and patient outcomes. BrioHealth Solutions is committed to addressing this shortfall. The immense enthusiasm of participating centers in advancing late-stage heart failure treatment through this trial brings us great reassurance."

BrioHealth Solutions was established in 2008 in Suzhou Industrial Park. After more than a decade of original innovation, it successfully developed the new-generation ultra-small full magnetic levitation artificial heart, CiFu.^®VAD (Model: CH-VAD), becoming China'sThe FirstThe full magnetic levitation implantable left ventricular assist device with complete independent intellectual property rights approved for marketing by the National Medical Products Administration (NMPA).

Currently, more than 350 patients in China have received treatment with CH-VAD, demonstrating excellent clinical outcomes.BrioVAD^®Equipped with the same implantable blood pump as CH-VAD, and through multiple technological innovations, it has achieved portability of external components and an overall improvement in system performance.

BrioVAD^®The system is a durable VAD capable of providing full-flow support, composed of an implantable blood pump and external components, designed to offer long-term support for heart failure patients. Compared with the only durable VAD currently approved by the U.S. FDA,BrioVAD^®The blood pump adopts an innovative discrete magnetic levitation design, achieving a perfect combination of a smaller pump body and a large impeller, which helps reduce surgical trauma. Additionally,BrioVAD^®Also adopts an innovative percutaneous cable design; the thinner and softer percutaneous cable helps reduce the associated risk of infection.

BrioVAD^®The unique magnetic levitation structure and large-diameter impeller of the blood pump also provide a foundation for optimizing the internal flow path of the pump. Advanced flow path design helps improve the device's hemocompatibility and hemodynamic performance, thereby reducing the risk of severe complications.

BrioVAD^®The external components of the system feature several unique designs, allowing patients to wear only two components daily, which helps enhance user experience and improve patients' quality of life.

The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multicenter, non-inferiority study that will conduct a randomized controlled comparison directly with the only fully magnetically levitated artificial heart previously approved by the FDA, aiming to comprehensively evaluateBrioVAD^®Effectiveness and Safety in Treating Refractory Heart Failure. The launch of this trial is of great significance for promoting innovation and development in the global ventricular assist device field.

Francis D. Pagani, M.D., Ph.D., the Otto Gago Professor of Cardiac Surgery at the University of Michigan Medical School and the lead investigator of this study, stated: "Treatment options for patients with advanced heart failure are limited, and currently, there is only one LVAD available for use in the United States. Despite advancements in treatment, patients with LVADs still experience various complications. The INNOVATE trial will validateBrioVAD^®"Whether the system can further help reduce complications and improve the quality of life for patients with advanced heart failure."

Mani Daneshman, MD, Andrew J. McKelvey Distinguished Professor at Emory University School of Medicine and Director of the Emory Heart and Lung Transplant and Mechanical Circulatory Support Program, stated, "The launch of the INNOVATE trial is an important milestone in expanding treatment options for patients with advanced heart failure, and we are very much looking forward to seeingBrioVAD^®"How the system benefits these patients."

WithBrioVAD^®Smooth Launch of Clinical Trials in the United States

BrioHealth Solutions not only pioneered

China's Artificial Heart Industry Paves the Way for U.S. Clinical Trials

Also established a milestone in the field of international heart failure treatment.

BrioHealth Solutions Poised to Reshape the Global Artificial Heart Industry Landscape

▲ Source of the article: BrioHealth Solutions

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