Cerus Endovascular has provided an update on its lead development programmes, including the Contour Neurovascular System as well as the NEQSTENT Intra-Saccular Stent.
“The past few months have been transformational for our company, as we have moved aggressively to further advance our portfolio of clinically differentiated aneurysm treatments and begin the transition to a commercial-stage company with the roll-out of Contour Neurovascular System in CE marking countries,” says J Todd Derbin, founder, chairman and chief executive officer of Cerus Endovascular. “As we enter this new phase, we look forward to building upon the successful outcomes seen to date, and to planned discussions with the US Food & Drug Administration (FDA) and other regulatory agencies. We strongly believe that our innovative devices have the potential to revolutionise aneurysm treatment, and we are eager to make this technology more broadly available to patients in need.”
Contour Neurovascular System
Since announcing CE mark approval of the Contour Neurovascular System in June 2017, Cerus Endovascular has made steady and continued progress toward transforming into a commercial-stage company. To date, 25 sites in Europe have been confirmed for limited commercial release of the system on a direct sales basis. Additionally, the company has assembled a steering committee comprised of leading experts in the field of aneurysm treatment to assist in the screening of appropriate patient cases.
NEQSTENT Intra-Saccular Stent
Cerus Endovascular also announced a successful first-in-man implantation of the NEQSTENT Intra-Saccular Stent at Odense University Hospital in Denmark. Additional cases are planned. The company is in the process of finalising its regulatory submission to European authorities and is targeting CE Mark approval in the second quarter 2018.
According to the company, the NEQSTENT Intra-Saccular Stent is designed to treat a wide range of aneurysm morphologies including wide-neck, side-wall and bifurcation aneurysms. It is an adjunctive device providing stable aneurysm neck coverage for the placement of embolisation coils within the sac and long-term stable occlusion of the aneurysm.
Cerus Endovascular has successfully completed all required chronic toxicity, genotoxicity and carcinogenicity testing for both Contour and NEQSTENT in preparation for a pre-IDE meeting with FDA in the coming months.