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 […]
FDA clears GI Scientific’s duodenoscope ScopeSeal
GI Scientific said today that the FDA cleared its ScopeSeal duodenoscope protective device for protecting the distal end of a duodenoscope from contamination during endoscopic retrogade cholangio-pancreatography procedures. ScopeSeal is a single-use device designed to seal the infection-prone distal end of a duodenoscope by attaching to the end and reducing biomatter soiling during use. It […]
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, […]
EndoGastric Solutions touts GERD treatment study
EndoGastric Solutions yesterday touted the results of a study that showed its EsophyX device was effective at treating certain hiatal hernia patients who have gastroesophageal reflux disease (GERD). The study concluded that and transoral incisionless fundoplication (TIF) using EsophyX is an effective treatment for patients with a hiatal hernia (HH) that is larger than 2 […]
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 […]
Sony to deal $760m stake back to Olympus
Sony (TYO:6758) will reportedly sell its 5% stake in Olympus (TYO:7733) back to the company for nearly $760 million. The deal for Sony’s 68.9-million-share stake is worth ¥80.4 billion, or about $756.7 million, Reuters reported. Hedge fund Third Point, run by activist investor Daniel Loeb, had called for Sony to divest its Olympus shares, although a Sony […]
FDA pushes duodenscope makers, users away from reprocessed devices
The FDA yesterday recommended that healthcare providers move away from a type of infection-prone duodenoscope in favor of devices that can better be sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.” In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as […]
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 […]
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