Sam Brusco, Associate Editor02.12.21
Cerus Endovascular Ltd. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System.
Indicated for treatment of intracranial aneurysms, the Contour Neurovascular System is composed of fine mesh braid. It is a unique intrasaccular advancement because it targets the neck of the aneurysm, away from the vulnerable dome. Additionally, the system is self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices.
"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," Cerus Endovascular president Dr. Stephen Griffin told the press. "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."
"We look forward to working with U.S. regulatory authorities to expedite the availability of this innovative device that could provide an effective, minimally invasive treatment for bifurcated, intracranial aneurysms, a life-threatening condition," added Dr. Adels. "Under this program, the FDA will provide us with timely, interactive communication, priority review and FDA senior management engagement regarding the development of efficient and flexible clinical trial protocols, through to commercialization strategy and decisions."
Dr. Sam Milstein, Cerus' Chairman, said, "International sales of the Contour System continue to accelerate, as the medical communities abroad recognize the tangible benefits of this device. We look forward to having a similar impact in the U.S. market."
Indicated for treatment of intracranial aneurysms, the Contour Neurovascular System is composed of fine mesh braid. It is a unique intrasaccular advancement because it targets the neck of the aneurysm, away from the vulnerable dome. Additionally, the system is self-anchored for stability, re-sheathable for precise placement, and because it is deployed across the neck, sizing criteria are less restrictive than other commercially available intrasaccular devices.
"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," Cerus Endovascular president Dr. Stephen Griffin told the press. "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."
"We look forward to working with U.S. regulatory authorities to expedite the availability of this innovative device that could provide an effective, minimally invasive treatment for bifurcated, intracranial aneurysms, a life-threatening condition," added Dr. Adels. "Under this program, the FDA will provide us with timely, interactive communication, priority review and FDA senior management engagement regarding the development of efficient and flexible clinical trial protocols, through to commercialization strategy and decisions."
Dr. Sam Milstein, Cerus' Chairman, said, "International sales of the Contour System continue to accelerate, as the medical communities abroad recognize the tangible benefits of this device. We look forward to having a similar impact in the U.S. market."