cerusendovascular Archives - Medical Design Sourcing

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 …

Cerus Endovascular neurovascular system wins FDA breakthrough device designation

Cerus Endovascular today said it has received FDA breakthrough device designation for its Contour Neurovascular System.

The Contour Neurovascular System is designed to treat intracranial aneurysms. It is made of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It can be self-anchored for stability, is re-sheathable for precise placement and the sizing criteria are less restrictive because of its deployment across the neck.

“Today’s news marks another significant milestone in our company’s evolution and is the direct result of the commitment and strength of our scientific team, led by Dr. Lori Adels, Chief Compliance Officer,” president Stephen Griffin said in a news release. “We anticipate initiating our U.S. clinical trial, under an Investigational Device Exemption, soon and will work aggressively to bring our already CE Mark-approved Contour technology to the U.S. market.”

The FDA iss…

Cerus Endovascular and Balt partnered to deliver Contour Neurovascular System in Germany

Cerus Endovascular and Balt this week announced a strategic distribution agreement to provide AB Medica with the exclusive rights to market and sell the Countour Neurovascular System and the Neqstent Coil Assisted Flow Diverter devices.

The distribution agreement is currently limited to Germany. The financial details of the deal were not disclosed.

“Our partnership with Balt, an internationally-recognized pioneer in the neurovascular sector, reflects the strength of our innovative product line and will provide significantly increased awareness and more rapid penetration of both the Contour Neurovascular System and the Neqstent device within Germany, the largest market within the European Union (EU),” president of Cerus Endovascular Stephen Griffin said in a news release. “Physicians in Germany have indicated their desire for greater access to our products and have, therefore, been very supportive of our decision to partner locally with AB Medi…