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 […]
FDA warns on two more Endologix stent grafts
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 […]
Medtronic wins FDA breakthrough nod for Valiant stent graft
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 […]
FDA OKs PQ Bypass trial of Torus peripheral stent graft
PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease. The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, […]
ESC Congress 2019: Biotronik beats Abbott at target lesion failure
Biotronik said yesterday that its Orsiro stent tops the Xience stents made by Abbott (NYSE:ABT) when it comes to target lesion failure, according to data from a clinical trial. The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced […]
Study: No mortality benefit from CABG at 10 years
A follow-up of surgical and medical treatment for congestive heart failure and coronary artery disease (STICH) showed that there’s no association between myocardial viability and the long-term mortality benefit of coronary artery bypass grafting (CABG) in patients with ischemic cardiomyopathy. The study, published yesterday in the New England Journal of Medicine, followed 601 patients with coronary […]
Endologix spikes plan for $25m offering
Endologix (NSDQ:ELGX) yesterday spiked its plan to sell as much as $25 million worth of its own stock, saying it has no intention of selling stock over the short term. The Irvine, Calif.-based company had tapped Piper Jaffray to offer more than 22.2 million shares at $6.45 apiece, with the proceeds earmarked for manufacturing, clinical trials, […]
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