Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system. The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a […]
Stent Grafts
Endologix CEO McDermott to step down; shares slide -10% on Q4 results | Personnel Moves for Feb. 22, 2018
Endologix (NSDQ:ELGX) CEO John McDermott is planning to step down once an appropriate replacement is found, the company said yesterday as it announced fourth-quarter results that handily topped earnings expectations but missed on the top line. “Despite the business challenges over the past couple of years, I am confident that Endologix has a bright future. Our […]
Strapped for cash, Lombard Medical defaults on loan
Strapped for cash, Lombard Medical Technologies (NSDQ:EVAR) said last week that it received a default notice from one of its lenders. The Didcot, U.K.-based stent graft maker said Oxford Finance sent the default letter Jan. 12, four days after meeting with Lombard to discuss its finances. To make matters worse, Lombard said it doesn’t have enough […]
PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study
PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease. The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 […]
Medtronic wins CE Mark for Endurant stent graft, HeliFX EndoAnchor combo
Medtronic (NYSE:MDT) this week won CE Mark approval in the European Union for combined treatment with its Endurant II or IIs stent graft and the Heli-FX EndoAnchor system in patients with short aortic anatomies. The combined treatment is now cleared with indications to that patients with aortic neck lengths down to 4mm with a less than […]
Regenerative vessel stent dev Cardiovate raises $1m
Early stage medical device developer Cardiovate has closed a $1 million seed round to help support research and development for a scaffold the company claims can help regenerate vascular tissue, according to an Xconomy report. The Texas-based company, formed in 2012 by a student and two University of Texas in San Antonio, is developing the […]
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 […]
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 […]
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 […]