EndoGastric Solutions said today that a Center for Medicare & Medicaid Services administrator granted reimbursement coverage for its EsophyX device for treating gastroesophageal reflux. National Government Services extended coverage for transoral incisionless fundoplication using the EsophyX device to some 9.3 million patients in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont and Wisconsin effective Dec. […]
Endoscopic
FDA expands indication for Attune Medical’s Enso esophageal temperature management device
Attune Medical said today that it won an expanded indication from the FDA for its Enso esophageal temperature management device. Formerly known as Advanced Cooling Therapy, Chicago-based Attune said the new indication covers extended duration of use for up to 72 hours. The triple lumen system is designed to be inserted into the esophagus, with two lumens […]
CryoLife inks $225m deal for German graft maker Jotec
CryoLife Inc. (NYSE:CRY) said yesterday that it agreed to a cash-and-stock deal worth $225 million to acquire German stent graft and surgical graft maker Jotec. The deal calls for Cryolife to pay $168.8 million in cash and the remaining $56.25 million in CRY shares, financed by a $225 million term loan and a $30 million […]
FDA approves new trial for Nellix stent graft from Endologix
Endologix (NSDQ:ELGX) said today that it won an investigational device exemption from the FDA for a clinical trial of its star-crossed Nellix stent graft, after the federal safety watchdog earlier this year asked for two-year follow-up data on the device. CEO John McDermott said the IDE approval sets the stage for a possible pre-market approval in […]
FDA warns on endoleaks with stent grafts
The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta. The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent […]
GID touts study showing EndoBarrier as good as gastric plication
New data from the Institute for Clinical and Experimental Medications found that gastric plication and GI Dynamics’ EndoBarrier device therapy showed similar outcomes for patients with type 2 diabetes and obesity. “On a basic science and mechanistic basis, both treatments (GP and EndoBarrier) substantially improved metabolic parameters and were associated with reduction in systemic inflammation […]
Endologix wins refined CE Mark indications for Nellix stent graft
Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use. The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical […]
Cantel Medical closes $61m BHT buyout
Cantel Medical (NYSE:CMN) said today that it closed its $60.8 million acquisition of German endoscope reprocessor BHT Hygienetechnik Holding. Gersthofen, Germany-based BHT, which employs about 100 people, put up sales of abut $24.5 million last year, according to Little Falls, N.J.-based Cantel. “Establishing leadership in our international markets is a key component of our strategy and this […]
Gore touts reduced portal hypertension, complications in Viatorr Tips trial
W.L. Gore & Associates today released preliminary data from a trial of its Viatorr Tips endoprosthesis with controlled expansion, touting reduced portal hypertension treatment complications when compared to the company’s legacy Tips device and bare metal stents. Data from the study was presented at The International Liver Congress 2017 in Amsterdam, the Flagstaff, Ariz.-based company […]
Nanotech derived from amniotic stem cells could help treat brain cancer
Creative Medical Technology Holdings (OTC:CELZ) touted its exosome technology today, reporting that it demonstrated an ability to regenerate healthy brain cells while selectively halting the growth of glioma brain cancer cells in a preclinical model. The company’s exosomes are vesicles harvested from amniotic stem cell technology, which it licensed from the University of California San Diego in an […]
Olympus ekes partial win in $7m verdict over tainted ‘scope
Olympus (TYO:7733) reportedly eked out a partial win yesterday, despite losing a nearly $7 million verdict over the tainted endoscopes implicated in a “superbug” outbreak at a Seattle medical center in which 18 patients died. Theresa Bigler sued the hospital and Olympus in March 2015; in a twist, Virginia Mason joined Bigler’s suit against Olympus, claiming that the […]