In addition to expanding its existing product portfolio of FDA approved 021 micro-catheter platform, the company has also announced that it is expanding the size offerings of its CE-marked Contour Neurovascular System platform to enable the treatment of aneurysms up to 18mm in diameter
FDA Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
US-based neuroradiology devices maker Cerus Endovascular has received the US Food and Drug Administration (FDA) 510(k) approval for its 027 micro-catheters.
The new micro-catheters will be offered in two lengths, expanding the company’s existing product portfolio of FDA approved 021 micro-catheter platform.
The company is planning for a limited release of the 027 micro-catheters in the US market from the second quarter of this year, with the 021 micro-catheters to follow subsequently.
It also intends to pursue CE mark approval for both sizes in this year, under the EU’s new Medical Devices Regulation (MDR) guidelines.
Cerus Endovascular R&D vice president Jeff Sarge said: “Our development work has demonstrated the superior characteristics of our micro-catheters, in comparison to currently commercially available devices and we look forward to their more broad-based usage.
“Importantly, the micro-catheters are not limited to supporting just the Cerus Endovascular Contour Neurovascular System and Neqstent family of products but can also be used by any other company devices which are compatible with 021 and 027 micro-catheters.
“Today’s therapeutic devices place more demands on a delivery system, and we have developed a micro-catheter platform designed to provide exceptional support and stability when delivering these devices within the neuro vasculature.”
Cerus offers CE marked products, Contour Neurovascular System and Neqstent Coil Assisted Flow Diverter, to treatable various intracranial aneurysms.
In addition to the FDA approval for its 027 micro-catheters, Cerus has announced that it is expanding the size offerings of its Contour Neurovascular System platform.
Comprising a fine mesh braid, the system is designed to be self-anchored for stability, re-sheathable for precise placement and targets the neck of the aneurysm.
The new additional sizes, 3mm, 18mm and 22mm, that are currently in development, would enable the treatment of aneurysms up to 18mm in diameter, said the company.
Upon approval, the larger sizes said to address an unmet clinical need for treating aneurysms 80% larger than current commercially available endo-saccular solutions.
Cerus Endovascular chairman Sam Milstein said: “The continued expansion of our portfolio and the increased market penetration are key elements of our ongoing commercialization strategy.
“The company’s commercial footprint now extends to over 330 clinical centers, worldwide, and will shortly be expanding further into Asia and launching in Central and South America. Enrollment in the Cerus Endovascular IDE trial in the United States continues as scheduled.”