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Endologix

The worst catheter-based device recalls of 2020

February 19, 2021 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Abbott Vascular, Applied Medical, Arrow International, Boston Scientific, Cook Medical, Endologix, LeMaitre Vascular, Medtronic, Teleflex, Vascular Solutions

Endologix wins CE Mark for Alto abdominal stent graft system

August 7, 2020 By Danielle Kirsh

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. […]

Filed Under: Regulatory/Compliance Tagged With: Endologix

MedTech 100 roundup: Medtech stocks bump along

July 13, 2020 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Endologix, Intersect ENT, MedTech 100 Index, Medtronic

Endologix files for bankruptcy, will go private

July 6, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Cardiovascular, Endoscopic, Featured, Stent Grafts, Vascular Tagged With: Endologix, FDA

Endologix recall of abdominal stent graft system is Class I

June 16, 2020 By Chris Newmarker

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 […]

Filed Under: Cardiovascular, Featured, Recalls, Regulatory/Compliance, Stents Tagged With: Endologix

Endologix shares fall on missed Q1 projections

May 12, 2020 By Danielle Kirsh

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 […]

Filed Under: Wall Street Beat Tagged With: Endologix

COVID-19 upends medtech’s financial outlook

April 7, 2020 By Sean Whooley

The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Contract Manufacturing, Diabetes, Diagnostics, Featured, Genomics/Molecular Diagnostics, Health Technology, Imaging, Implants, MassDevice Earnings Roundup, Patient Monitoring, Wall Street Beat Tagged With: Check-Cap, coronavirus, COVID-19, Cutera Inc., Endologix, Hologic, Iradimed Corp, Livongo, Myomo Inc, Natus Medical Inc., NovoCure, Penumbra Inc., Shockwave Medical, Silk Road Medical Inc., Zynex

Endologix wins FDA approval for abdominal stent graft system

March 16, 2020 By Danielle Kirsh

Endologix today said it received FDA approval for its Alto abdominal stent graft system. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]

Filed Under: Regulatory/Compliance, Stents Tagged With: Endologix

Endologix rises after posting improved Q3 earnings

November 7, 2019 By Sean Whooley

Endologix (NSDQ:ELGX) shares are up today on third-quarter results that improved from the same quarter last year and topped the consensus forecast. The Irvine, Calif.-based AFX stent graft developer posted losses of -$7.8 million, or -40¢ per share, on sales of 35.8 million for the three months ended Sept. 30, for a 23.2% bottom-line gain on […]

Filed Under: MassDevice Earnings Roundup, Stent Grafts, Wall Street Beat Tagged With: Endologix

Endologix defends AFX stent grafts after FDA warning

November 1, 2019 By Brad Perriello

Endologix (NSDQ:ELGX) moved to defend its AFX stent grafts after the FDA this week warned of the risk of endoleaks with the devices, which are used to treat abdominal aortic aneurysms. The FDA added the Irvine, Calif.-based company’s The AFX with Duraply and AFX2 to last year’s warning about the AFX with Strata device, citing data […]

Filed Under: Featured, Food & Drug Administration (FDA), Stent Grafts Tagged With: Endologix

FDA warns on two more Endologix stent grafts

October 28, 2019 By Sean Whooley

Updated on Oct. 29 with comments from Endologix. Endologix (NSDQ:ELGX) shares plummeted today after the FDA issued a warning for patients using the company’s AFX endovascular stent grafts for the treatment of abdominal aortic aneurysms. The AFX with Duraply and AFX2 were all mentioned by the FDA as stent grafts with a risk of endoleaks, along […]

Filed Under: Food & Drug Administration (FDA), Recalls, Stent Grafts Tagged With: Endologix, FDA

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