Jetfall® Medical Carbon Dioxide Angiographic Injector and Accessories Approved by NMPA

Release time:

2026-03-31 09:14

Source:

On March 24, 2026, the National Medical Products Administration (NMPA) announced on its official website the granting of a medical device registration certificate for the Medical Carbon Dioxide Angiographic Injector and Accessories—a Class III innovative medical device independently developed by AMT MEDICAL INC.

As the first Class III carbon dioxide angiographic injection device in China, the Jetfall® Medical Carbon Dioxide Angiographic Injector and Accessories integrate breakthrough patented technologies with a semi-automatic, non-electric, and portable design. By replacing conventional iodine-based contrast media with carbon dioxide, the device offers a safer and more effective angiographic solution for high-risk patient populations with contraindications to iodine-based contrast agents—such as those with iodine allergies, renal insufficiency, or hyperthyroidism. This innovative approach not only addresses the limitations of traditional contrast agents in specific patient groups but also significantly enhances the safety of angiographic procedures and patient comfort.

Real-world clinical data demonstrate that the carbon dioxide angiography technology employed by this product effectively eliminates the risk of contrast-induced nephropathy (CIN) associated with traditional iodine-based contrast media in patients with renal impairment. Results from multi-center clinical studies in China indicate that, among patients with a pre-angiography estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m², the incidence of contrast-induced nephropathy was 0%, and the incidence of serious adverse events was also 0%.

As the first innovative medical device approved by the NMPA in this field, the successful launch of Jetfall® has become a significant milestone in the field of peripheral vascular intervention in China. Initially, the product obtained CE-MDR certification in early 2025 and has now been approved and commercialized in more than 20 countries and regions worldwide, including the United States, the European Union, the United Kingdom, Brazil, Turkey, Israel, and the Middle East. This achievement highlights the global expansion of China’s medical innovation, providing a more advanced, safer, and more effective angiographic solution for patients with contraindications to iodine-based contrast media, both in China and around the world. Global angiography is now entering a new era: the “zero-iodine” era.

Medical Carbon Dioxide Angiographic Injector and Accessories,NMPA

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