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Stent Grafts

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

LeMaitre Vascular acquires Artegraft

June 23, 2020 By Sean Whooley

LeMaitre Vascular (NSDQ:LMAT) announced that it acquired the business and assets of Artegraft in a deal worth $90 million. Under the terms of the acquisition, LeMaitre will pay $72.5 million in cash at closing, with $65 million for Artegraft, plus $7.5 million in escrow to be released on Dec. 31, 2021. There is an additional $17.5 […]

Filed Under: Business/Financial News, Endoscopic, Mergers & Acquisitions, Stent Grafts, Vascular Tagged With: Artegraft, LeMaitre Vascular Inc.

15 heart devices that could boost their manufacturers’ sales

May 22, 2020 By Nancy Crotti

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Food & Drug Administration (FDA), Hospital Care, Implants, Regulatory/Compliance, Replacement Heart Valves, Stent Grafts, Stents, Structural Heart, Wall Street Beat Tagged With: Abbott, Aris CV, Cardiofocus, cardiovalve, CE Mark, CryoLife, endospan, FDA, Medtronic, Terumo Aortic, V-Wave

Ascyrus Medical raises $5.2m

January 31, 2020 By Sean Whooley

Aortic dissection stent graft maker Ascyrus Medical announced that it sold nearly $5.2 million in an equity offering. The Boca Raton, Fla.–based company has no equity left to be sold in the offering, having collected approximately $5.18 million from six different investors. The minimum investment accepted was $39,997. Ascyrus Medical did not disclose the issuer […]

Filed Under: Business/Financial News, Endoscopic, Funding Roundup, Stent Grafts Tagged With: ascyrusmedical

Gore announces some Excluder problems in Europe

January 17, 2020 By Sean Whooley

W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch. Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore […]

Filed Under: Cardiovascular, Endoscopic, Featured, Recalls, Regulatory/Compliance, Stent Grafts, Vascular Tagged With: W.L. Gore & Associates

CryoLife wins CE Mark for E-nya thoracic stent graft

December 6, 2019 By Sean Whooley

CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for its E-nya thoracic stent graft system for minimally invasive procedures intended to repair lesions of the descending thoracic aorta, including thoracic aortic aneurysms and dissections. In December 2017, CryoLife completed the $225 million acquisition of German stent graft and surgical graft maker Jotec. Kennesaw, Ga.-based […]

Filed Under: Endoscopic, Featured, Regulatory/Compliance, Stent Grafts Tagged With: CryoLife

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

Japan approves Medtronic’s Valiant Navion stent graft

October 31, 2019 By Sean Whooley

Medtronic (NYSE:MDT) said today that it received Shonin approval and launched its Valiant Navion thoracic stent graft system in Japan for the minimally invasive repair of thoracic descending aortic aneurysms and Type B aortic dissections. The Fridley, Minn.-based company said it is the third major geographical launch of the Valiant Navion system after it won FDA […]

Filed Under: Regulatory/Compliance, Stent Grafts, Vascular Tagged With: Medtronic

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

Medtronic wins FDA breakthrough nod for Valiant stent graft

October 8, 2019 By Sean Whooley

Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its Valiant TAAA stent graft for treating thoracoabdominal aortic aneurysms. The newest Valiant graft is designed for minimally invasive repair of TAAA, a complex condition that causes a bulging of the aorta. The standard of care is open surgery, which is associated […]

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

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