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
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 […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
Endologix wins CE Mark for Alto abdominal stent graft system
Endologix (NSDQ:ELGX) this week said it received CE mark approval for its Alto Abdominal Stent Graft System. “We are very excited to receive a CE Mark for the Alto system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI,” chief medical officer Matt Thompson said in a news release. […]
MedTech 100 roundup: Medtech stocks bump along
Medical device company stocks appear to be in a holding pattern as investors wait for new earnings reports. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — bumped along last week. It closed at 84.39, about where it had been at the start of the week. The Dow Jones […]
Endologix files for bankruptcy, will go private
Endologix (NSDQ:ELGX) announced today that it has filed for Chapter 11 bankruptcy protection and simultaneously agreed to be purchased by its largest creditor. That creditor, Deerfield Partners, will take the Irvine, Calif.-based abdominal aortic aneurysm (AAA) stent graft developer private. The bankruptcy filing and sale “provide the best path to address the financial challenges resulting from […]
Endologix recall of abdominal stent graft system is Class I
Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Endologix shares fall on missed Q1 projections
Endologix (NSDQ:ELGX) posted first-quarter results that missed the consensus forecast on Wall Street and cut its outlook for the rest of the year. The company — maker of endovascular stent-grafts for the treatment of abdominal aortic aneurysms (AAA) — reported losses of -$18.1 million, or -90¢ per share, on sales of $28.5 million for the three […]
