FDA clears Cerus Endovascular 027 microcatheters

Cerus Endovascular this week announced the FDA 510(k) clearance of its 027 microcatheters.

Fremont, California-based Cerus Endocascular’s new microcatheters are available in two lengths and the company expects to submit for CE mark approval under the EU new medical devices regulation later this year.

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FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study

Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System.

Fremont, Calif.–based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. Its creators made it of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome.

It’s possible to self-anchor the system for stability. It’s re-sheathable for precise placement, and the sizing criteria are less restrictive because of its deployment across the neck. It received FDA breakthrough device designation in February of this year.

According to a news release, the study is designed to produce a data set that will support the safety and efficacy of the Contour Neurovascular System for the endovascular embolization of wide-necked, bifurcated, saccular intracranial aneurysms. Cerus intends to submit results in a premarket approval application to the FDA.

“We …

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Cerus Endovascular wins CE mark for microcatheter

Cerus Endovascular today said it received CE mark approval for its CerusEndo MC 021 microcatheter.

The microcatheter is designed to allow physicians to access torturous neurovasculature and deliver therapeutic device to intended targets.

“We remain committed to meeting the ever-increasing needs of the interventional neuroradiologist community, and with that in mind, our team has clearly identified a range of increased performance demands required of a go-to intracranial access microcatheter,” president Stephen Griffin said in a news release. “As a result, we have expanded our key 021 platform so that it can deliver a wider range of devices than it was originally designed for including stents, braided flow diverters and stentrievers, for treatment of both hemorrhagic and ischemic strokes. In particular, the 021 ensures predictable stability and control when delivering larger and braided devices through the device lumen.”

Microcathe…

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