As per an announcement by Endologix, a California-based healthcare technology company, the breakthrough device designation was given by Food and Drugs Administration (FDA) to its ChEVAS (Chimney Endovascular Aneurysm Sealing) system for patients with abdominal aortic aneurysm (AAA). The ChEVAS system is an innovative endovascular AAA sealing remedy that uses the Nellix® 3.5 endograft in conjunction with parallel visceral stents to treat patients with juxtarenal, pararenal, and suprarenal AAA.

The ChEVAS ONE IDE (Investigational Device Exemption) clinical research, which has been approved to enroll around 120 patients across 50 locations worldwide, is evaluating the ChEVAS system.

James McKinsey, MD, the leading enroller for the ChEVAS One IDE study, said, “The aneurysm sac sealing technology featured in the ChEVAS system is designed to reduce endoleaks, including gutter endoleaks, that are reported after endovascular treatment of complex aneurysms. Our initial clinical results of this therapy have been promising in a challenging group of patients.”

Through the FDA Breakthrough Devices Program, patients are given the opportunity to get faster access to medical devices that may help them treat or diagnose life-threatening or irreversibly debilitating diseases or conditions more effectively. FDA prioritizes Breakthrough Devices for assessment, and the program allows for early involvement with FDA personnel in order to fasten up the review and approval process.

“The ChEVAS System represents an important therapy that provides an ‘off-the shelf’ treatment to an underserved patient population who have complex abdominal aortic aneurysms. We are delighted that the FDA has designated ChEVAS as a Breakthrough Device, as this will facilitate our ability to develop this technology and make it available to patients in an expedited fashion. The ChEVAS System joins the PQ Bypass DETOUR System as the two FDA designated Breakthrough Devices in our clinical investigational programs, which is reflective of our aspiration to provide innovative and disruptive technologies to address clinically relevant therapeutic gaps,” said Matt Thompson, MD, chief medical officer at Endologix. 

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Keywords

Disease Condition,Therapeutic Modality,Valvular Heart Disease,Interventional Cardiology,Aortic Stenosis,TINC_others

Source

https://www.cardiovascularbusiness.com/topics/vascular-endovascular/fda-grants-breakthrough-device-designation-new-aaa-sealing-system