Qiming Medical -B (02500) announced that the company's independently developed transcatheter pulmonary valve replacement (TPV...) was successfully implanted in the first patient in the United States PROTEUS IDE clinical trial of the VenusP-Valve system. This marks a significant milestone in the international clinical development of VenusP-Valve, following its European CE MDR certification in April 2022. The launch of this clinical trial indicates that VenusP-Valve is expected to become the first China-manufactured artificial heart valve system to be approved globally, and is able to compete with Europe and the United States. This fully demonstrates the research and clinical development capabilities of China's innovative medical devices.
Qiming Medical -B (02500) announced that the company's independently developed transcatheter pulmonary valve replacement (TPVR) system VenusP-Valve's United States PROTEUS IDE clinical trial has officially launched and the first patient has been successfully implanted. This marks a significant milestone in the international clinical development of VenusP-Valve, following its European CE MDR certification in April 2022. The start of this clinical trial means that VenusP-Valve is expected to become the first China-manufactured artificial heart valve system to be approved globally, and is able to compete with Europe and the United States. It fully demonstrates the research and clinical development capabilities of China's innovative medical devices.
The VenusP-Valve PROTEUS clinical trial is a prospective, multicenter, non-randomized, intervention study conducted on patients with autologous right ventricular outflow tract (RVOT) obstruction accompanied by moderate to severe pulmonary artery regurgitation. The study will include 60 subjects, and the study data will support registration applications to the US FDA and Japanese PMDA at the same time. This study, which was approved by the US Centers for Medicare and Medicaid Services (CMS) in December 2023, makes VenusP-Valve eligible for reimbursement under CMS related medical insurance plans during clinical trials. This encourages patients to actively participate in clinical trials and promotes the progress of clinical research.
Since the first clinical operation in 2013, VenusP-Valve has been in clinical use for 11 years. Currently, VenusP-Valve has been included in the medical insurance of countries such as Germany and France, and has been registered for sale in more than 50 mainstream countries such as China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia. It continues to be implanted in medical institutions newly covered by medical insurance. As the first self-expanding TPVR product approved for sale in China and Europe, VenusP-Valve has significant clinical value. Its unique double-bell mouth design, bare stent design at the outflow end to ensure branch blood flow, stable multi-site anchoring characteristics, simple release, and no need to place a fixed stent before implantation. It has multiple valve size specifications and a broad range of applications, and can meet the needs of more than 85% of large-pulmonary-artery valve patients in clinical practice.
The key clinical launch of VenusP-Valve in the United States is an important step for the company in the global key market. The board of directors looks forward to VenusP-Valve completing patient enrollment and obtaining clinical follow-up results as soon as possible, supporting its approval for sale in the US market, and providing better innovative treatment options for patients and doctors worldwide.
As the first TPVR product approved for sale in China and Europe, VenusP-Valve has significant clinical value. Its unique double-bell mouth design, bare stent design at the outflow end to ensure branch blood flow, stable multi-site anchoring characteristics, simple release, and no need to place a fixed stent before implantation. It has multiple valve size specifications and a broad range of applications, and can meet the needs of more than 85% of large-pulmonary-artery valve patients in clinical practice.
The three-year follow-up data for VenusP-Valve in Europe showed that among 81 patients who underwent TPVR surgery, the surgical success rate was 100%, the all-cause mortality rate and re-intervention rate were both 0, right ventricular function was significantly improved, and only 1 patient had severe pulmonary valve regurgitation.
The key clinical launch of VenusP-Valve in the United States is an important step for the company in the global key market. The board of directors looks forward to VenusP-Valve completing patient enrollment and obtaining clinical follow-up results as soon as possible, supporting its approval for sale in the US market, and providing better innovative treatment options for patients and doctors worldwide.