Endologix (NSDQ:ELGX) share prices opened up nearly 28% today after the stent graft maker’s preliminary third-quarter sales beat the consensus forecast and it raised the bottom of its top-line outlook for the rest of the year. Irvine, Calif-based Endologix said it expects to report sales of $34.3 million to $34.7 million for the three months ended […]
Stent Grafts
Gore tests stent graft for deadly heart condition
W. L. Gore & Associates announced the first implant of its ascending stent graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The surgery was part of Gore’s ARISE study, the first multicenter, early feasibility study approved by the FDA to investigate how […]
Gore touts regulatory wins for new balloon catheter
W.L. Gore & Assoc. said today that its molding & occlusion balloon won a trifecta of regulatory nods in the U.S., Japan and Europe. The Flagstaff, Ariz.-based company said the device is designed to deliver stent grafts or temporarily occlude large-diameter vessels during endovascular aortic repair procedures. In addition to 510(k) clearance from the FDA, […]
Endologix pushes Nellix release timeline to 2021
Endologix (NSDQ:ELGX) said it doesn’t expect to receive FDA premarket approval for its Nellix 3.5 endovascular sealing system until 2021. The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021. The forecast is […]
Gore touts first use of Tag conformable thoracic stent graft in Australia
W.L. Gore & Associates said yesterday that it launched its Gore Tag conformable thoracic stent graft with active control in Australia, touting that the first procedures with the device have been performed in the region. The first implant procedures with the device were performed by Dr. Ian Spark of Adelaide, Australia’s Flinders Medical Centre, Gore said. […]
FDA warns on leak risk with discontinued Endologix stent graft
The FDA yesterday warned of an increased risk of serious endoleaks with a discontinued stent graft once made by Endologix (NSDQ:ELGX). Last September the federal safety watchdog warned physicians about the risk of endoleaks with stent grafts used to wall off aneurysms in the abdominal aorta. The FDA said at the time that the warning was […]
FDA panel backs Cardinal Health’s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system. The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced […]
Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft
Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms. On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for […]
Endologix promotes COO to corner office, posts mixed Q1 results
Endologix (NSDQ:ELGX) promoted chief operating officer John Onopchenko to CEO just in time for him to take the lead on the company’s first-quarter financial results. Onopchenko served as the Irvine, Calif.-based company’s COO for the past seven months. He has spent 30 years in the medical device industry, including nearly a decade at Johnson & Johnson (NYSE:JNJ), […]
Terumo Aortic launches feasibility study of RelayBranch thoracic stent-graft
Terumo Aortic, which formed earlier this month from a merger between Terumo Corp. (TYO:4543) subsidiary Vascutek and Bolton Medical, said today it launched an early feasibility study of its RelayBranch thoracic stent-graft system. The Sunrise, Fla.-based company said that the first two patients in the study have been implanted with the device by Dr. Luis Sanchez and […]
MicroPort Scientific buys Lombard Medical out of bankruptcy
Lombard Medical Technologies (NSDQ:EVAR) said today that it was acquired out of bankruptcy by MicroPort Scientific (HK:00853), which hopes to get Lombard’s stent grafts on the market in China. MicroPort put $15 million into Lombard back in December 2016 in a deal that aimed to accelerate the commercialization of Lombard’s Aorfix and Altura stent grafts for treating abdominal […]