Endologix announced today that the first patients underwent a procedure using its Detour system since it received FDA approval. The FDA approved Detour for use in percutaneous transmural arterial bypass (PTAB) to treat peripheral arterial disease (PAD) last month. This initial procedure marks the official start of the company’s targeted market release of Detour in […]
Endologix
2-year data supports Endologix Detour system for treating PAD
About a week after garnering FDA approval, Endologix announced positive 24-month data for its Detour system for treating PAD. Irvine, California–Endologix picked up premarket approval on June 7 for its Detour system to treat long, complex superficial femoropopliteal lesions. The DETOUR2 study evaluated the system’s performance in percutaneous transmural arterial bypass (PTAB). This approach aims […]
FDA approves new Endologix peripheral arterial disease treatment
Endologix recently announced it received FDA approval for its Detour system to treat long, complex superficial femoropopliteal lesions. Company officials describe the Detour system as a breakthrough in the treatment of peripheral arterial disease (PAD), which the CDC estimates affected roughly 6.5 million Americans over 40. The present recommended therapy is open surgical bypass, an […]
Endologix wins CE mark for abdominal aortic aneurysm system
Endologix announced today that it received CE mark approval for its AFX2 endovascular abdominal aortic aneurysm (AAA) system. Irvine, California-based Endologix designed the AFX2 system with unique sealing technology that preserves native bifurcation to provide durable outcomes and personalized repair for AAA patients. “CE Mark certification under the new [EU MDR] requirements is a high-bar […]
Endologix reports positive results from percutaneous bypass trial
Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications. Irvine, California-based Endologix’s Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of long-segment femoropopliteal disease. Get the full story […]
Matthew Thompson promoted to corner office at Endologix
Dr. Matthew Thompson, who has served as chief medical officer at Endologix since 2016, has been promoted to CEO of the vascular disease treatments company. Richard Mott, who has been serving as interim CEO, will return to his role as executive chair of the company’s board of directors, Endologix announced November 10. On top of […]
Endologix wins FDA breakthrough nod for aneurysm sealing system
Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas). Irvine, Calif.–based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according […]
Endologix launches Alto abdominal stent graft in Canada
Endologix (NSDQ:ELGX) today said it launched its Alto abdominal stent graft in Canada following its recent Health Canada approval. The Alto abdominal stent graft system is a polymer-based therapy for abdominal aortic aneurysm (AAA) patients. It uses a low-profile delivery system with a conformable sealing ring that molds in-situ to the patient’s specific aortic neck anatomy. […]
DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?
In this week’s DeviceTalks Weekly Podcast, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics. Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of […]
Endologix acquires PQ Bypass
Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount. PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass — providing a large lumen, endograft bypass to treat abdominal aortic aneurysm. FDA has designated Detour as a breakthrough device. The Detour System has the company’s […]
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
