The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Stent Grafts
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
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 […]
LeMaitre Vascular acquires Artegraft
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 […]
15 heart devices that could boost their manufacturers’ sales
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 […]
Ascyrus Medical raises $5.2m
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 […]
Gore announces some Excluder problems in Europe
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 […]
CryoLife wins CE Mark for E-nya thoracic stent graft
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 […]
Endologix rises after posting improved Q3 earnings
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 […]
Endologix defends AFX stent grafts after FDA warning
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 […]
Japan approves Medtronic’s Valiant Navion stent graft
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 […]
