Penumbra, Inc. has received CE Mark approval in Europe for THUNDERBOLT, its computer assisted vacuum thrombectomy (CAVT) technology for the treatment of acute ischaemic stroke. The milestone follows recent clearance from the U.S. Food and Drug Administration (FDA), supporting the company's plans to expand the technology globally.

THUNDERBOLT is designed to improve clot removal during stroke treatment. Powered by the Penumbra ENGINE platform, the system uses modulated aspiration technology to detect, weaken and fully remove blood clots at the site of vessel blockage.

The company stated that THUNDERBOLT is the first and only CAVT device approved for stroke treatment in both Europe and the United States. The technology expands Penumbra’s neurovascular thrombectomy portfolio and builds on more than two decades of research and development.

Stroke remains one of the leading causes of death worldwide, and incomplete clot removal can increase the risk of disability, complications and mortality. Penumbra believes the new technology could help improve treatment efficiency and patient outcomes by enhancing clot extraction during thrombectomy procedures.

The company also highlighted that THUNDERBOLT has the potential to reduce procedure times, which may contribute to improved patient safety and streamlined clinical workflows.

THUNDERBOLT will be supplied with selected catheters from Penumbra’s RED product family, including RED 62, RED 68, RED 72 SILVER LABEL and RED 72 SILVER LABEL with SENDit technology.

The European approval represents an important step in the broader adoption of computer assisted vacuum thrombectomy technology for acute ischaemic stroke treatment and strengthens Penumbra’s position in both vascular and neurovascular care.

 

Source: prnewswire.com

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