Cerus Endovascular’s 027 Microcatheter Cleared by FDA

March 23, 2022—Cerus Endovascular Ltd., a developer of neuroradiological devices for endosaccular treatment of intracranial aneurysms, announced that it has received FDA 510(k) clearance for its 027 microcatheters, which are available in two lengths. The company’s product portfolio also includes the FDA-cleared 021 microcatheter platform.

Cerus Endovascular expects to begin a limited market release of the 027 microcatheters in the United States in the second quarter of 2022, which will be followed by the release of the 021 microcatheter platform.

Later this year, the company expects to submit both sizes for CE Mark approval under the European Union’s new Medical Devices Regulation.

The microcatheters support Cerus Endovascular’s Contour neurovascular system and Neqstent family of products. They can also be used to support any other company’s devices that are compatible with 0.021- and 0.027-inch microcatheters.

Additionally, Cerus Endovascular announced that it is expanding the size offerings of its Contour neurovascular system platform. The newer additional sizes that are currently in development include 3, 18, and 22 mm, which will allow for the treatment of aneurysms up to 18 mm in diameter.

According to the company, the Contour device is composed of a fine-mesh braid that targets the neck of the aneurysm, away from the vulnerable dome. The system is designed to be self anchored for stability and resheathable for precise placement. It is deployed across the neck, making sizing criteria less restrictive.

The Contour neurovascular system has received European CE Mark approval. It is an investigational device in the United States and is not available for sale. Neqstent has CE Mark approval and is not available for sale or use in the United States, advised Cerus Endovascular.