Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use. The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical […]
Endologix
Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data
Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair. The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization […]
Endologix touts data from AFX, AFX 2 aortic stent graft trial
Endologix (NSDQ:ELGX) touted data today from its Leopard clinical trial, which compared Endologix’s AFX and AFX2 endografts to other commercially available bifurcated aortic endografts. The trial, which launched in 2015, has since enrolled 458 patients. The study’s primary endpoint is freedom from aneurysm-related complications, including aneurysm rupture, conversion to open repair and endoleaks. Freedom from ARC […]
NuVasive taps new CFO | Personnel Moves – August 15, 2017
NuVasive Inc. (NSDQ:NUVA) said today that it tapped Rajesh Asarpota to be its new CFO effective Sept. 1, replacing Quentin Blackford, who jumped ship last month for the top finance spot at Dexcom Inc. (NSDQ:DXCM). San Diego-based NuVasive said Asarpota began his career at GE Healthcare (NYSE:GE)before moving to Life Technologies (NSDQ:LIFE), Questcor Pharmaceuticals and “private equity-backed healthcare […]
Endologix shares tumble on Q2 miss
Shares in Endologix (NSDQ:ELGX) fell over 10% today after the medical device maker missed expectations on Wall Street with its 2nd quarter earnings results. The Irvine, Calif.-based company posted losses of $16.3 million, or 20¢ per share, on sales of $48.6 million for the 3 months ended June 30, seeing losses shrink 75.6% while sales shrunk […]
Endologix touts low rate of endoleaks, mortality in 2-year Nellix study results
Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities. Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and […]
Endologix touts 30-day data from study of Ovation stent graft in women
Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to […]
Endologix dives on 2-year setback for Nellix stent graft
Endologix (NSDQ:ELGX) shares were off more than 30% this morning after the company yesterday revealed a 2-year setback for its Nellix stent graft for repairing abdominal aortic aneurysms. Irvine, Calif.-based Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when […]
Endologix inks $170m credit facility with Deerfield
Endologix (NSDQ:ELGX) said this week it inked a credit facility worth up to $170 million with Deerfield Management. Money in the facility will be provided through a $120 million 6-year secured term loan and a $50 million 3-year secured asset-based revolving line of credit, the Irvine, Calif.-based company said. Under the loan facility, Deerfield will provide […]
Trumpcare’s prospects dim, but not too dim to hit stent graft makers
The push on Capitol Hill to revive Trumpcare stalled yesterday, but not before the chatter out of Washington instigated a slide for stent graft makers’ stocks. The Affordable Care Act covers a 1-time screening for abdominal aortic aneurysms in men who smoke or smoked in the past, listing the test as an “essential health benefit.” The […]
7 medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are 7 medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press […]