Good News | Matrix Medical’s Intracranial Laser Balloon Dilatation Catheter Earns FDA Breakthrough Device Designation

Matrix Medical Secures FDA Breakthrough Device Designation – Joins Global Top Tier in Neurointervention Innovation

Matrix Medical’s independently developed Intracranial Laser Balloon Dilatation Catheter has recently received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (a classification for breakthrough medical devices). This achievement signifies a major breakthrough for the company in the high-end neurointerventional device sector, and also marks that Matrix Medical has officially joined the ranks of globally leading innovative enterprises. As one of the most prestigious regulatory pathways worldwide, this designation reflects the FDA’s high recognition of the product’s innovative value, potential clinical benefits, and ability to address unmet clinical needs.

Widely regarded as the "ultimate authority" for cerebrovascular disease treatments globally, the FDA’s Breakthrough Device Designation is centered on the core criteria of "high innovation, high value, and high necessity" — a recognition widely endorsed across the entire medical device industry.

Targeting ICAS Clinical Pain Points: Opening a New Treatment Pathway

Intracranial Atherosclerotic Stenosis (ICAS) is a high-prevalence condition in China. While current medication-based management strategies benefit some patients, many still have limited response to medication. Existing interventional treatments also have limitations in improving outcomes, leaving patients with severe stenosis unable to achieve sufficient clinical benefits.

Matrix Medical’s Laser Balloon Dilatation Catheter focuses on intracranial atherosclerotic lesions. Through precise energy control and selective dilation, it is expected to overcome the limitations of traditional technologies, providing a more controllable and safer innovative treatment option for ICAS patients unresponsive to medication.

International Recognition for Technical Strength: China’s Original Innovation Rises Rapidly

Neurointervention – defined by complex anatomical structures and high operational difficulty – has long been the most challenging sub-sector in vascular intervention. Leveraging its original technical reserves in energy control, minimally invasive design, and systematic device innovation, Matrix Medical gained unanimous recognition from the FDA expert team. This makes it a representative case of Chinese enterprises achieving key milestones in the high-barrier neurointerventional sector.

This not only demonstrates the company’s solid R&D capabilities but also mirrors the accelerating rise of China’s original medical devices in the global innovation landscape.

Accelerated Global Layout: China’s Original Technology Debuts on the European Stage

The FDA Breakthrough Designation not only validates Matrix Medical’s technical strength but also infuses new momentum into its global expansion efforts. Recently, Matrix Medical made its debut at the MEDICA International Medical Device Exhibition in Düsseldorf, Germany, showcasing China’s original neurointerventional technologies on a world-class platform.

Through in-depth exchanges with channel partners, clinical experts, and industry institutions across multiple countries, the company is accelerating the building of a global cooperation network. This will drive its innovative technologies to enter international markets more efficiently, enabling China’s original solutions to benefit a broader global patient population more quickly.

Receive the latest updates from Matrix Medical in real time to understand product information.

Targeting ICAS Clinical Pain Points: Opening a New Treatment Pathway

International Recognition for Technical Strength: China’s Original Innovation Rises Rapidly

Accelerated Global Layout: China’s Original Technology Debuts on the European Stage

Ready to cooperate with us?