Sam Brusco, Associate Editor03.24.22
Cerus Endovascular obtained U.S. Food and Drug Administration (FDA) clearance for its 027 microcatheters in two lengths. The firm intends to submit for CE marking of both sizes under the new EU MDR later this year.
Limited market release is expected to begin in the second quarter of this year, with the 021 micro-catheters platform to follow shortly after.
"Our focus on continually meeting the demands of the clinical and physician communities, including interventional radiologists, with timely, value-added products, is evidenced by this latest FDA approval for the 027 micro-catheters, for which sales will commence shortly, both domestically and internationally," Dr. Stephen Griffin, president of Cerus Endovascular told the press.
Jeff Sarge, VP of R&D at Cerus Endovascular, noted, "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 neurovasculature," concluded Sarge.
The company is also expanding its Contour neurovascular system size offerings, which are currently in development (3, 18, and 22mm). Dr. Griffin said the larger sizes will be able to treat aneurysms 80% larger than current endo-saccular systems.
The company envisions a future with a more simplified endo-saccular approach to aneurysm treatment will be a “go-to” solution and reduce the need for parent artery stents and flow diverters in most procedures.
"The continued expansion of our portfolio and the increased market penetration are key elements of our ongoing commercialization strategy," stated Dr. Sam Milstein, chairman of Cerus Endovascular. "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."
Limited market release is expected to begin in the second quarter of this year, with the 021 micro-catheters platform to follow shortly after.
"Our focus on continually meeting the demands of the clinical and physician communities, including interventional radiologists, with timely, value-added products, is evidenced by this latest FDA approval for the 027 micro-catheters, for which sales will commence shortly, both domestically and internationally," Dr. Stephen Griffin, president of Cerus Endovascular told the press.
Jeff Sarge, VP of R&D at Cerus Endovascular, noted, "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 neurovasculature," concluded Sarge.
The company is also expanding its Contour neurovascular system size offerings, which are currently in development (3, 18, and 22mm). Dr. Griffin said the larger sizes will be able to treat aneurysms 80% larger than current endo-saccular systems.
The company envisions a future with a more simplified endo-saccular approach to aneurysm treatment will be a “go-to” solution and reduce the need for parent artery stents and flow diverters in most procedures.
"The continued expansion of our portfolio and the increased market penetration are key elements of our ongoing commercialization strategy," stated Dr. Sam Milstein, chairman of Cerus Endovascular. "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."