Endologix shares dive on FDA request for more Nellix data
Endologix (NSDQ:ELGX) shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms.
Irvine, Calif.-based Endologix said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of 2017, pushes potential pre-market approval from the FDA back to the 2nd quarter of 2018, Endologix said.
Investors reacted by pushing ELGX shares down -24.5% to $7.43 apiece today in mid-morning trading.
“We’re disappointe...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Wall Street Beat Endologix Inc. Source Type: news
Abdominal Aneurysm Risk Drops When Smokers Quit
And the longer it is since you had a cigarette, the lower your odds of trouble, study suggests
Source: HealthDay
Related MedlinePlus Pages: Aortic Aneurysm, Smoking (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - November 11, 2016 Category: Consumer Health News Source Type: news
Abdominal Aneurysm Risk Drops When Smokers Quit
FRIDAY, Nov. 11, 2016 -- Smokers have an elevated risk of dangerous aneurysms in the body ' s largest artery, but quitting can cut those odds, a new study confirms.
Experts have long known that smoking raises the risk of abdominal aortic aneurysm --... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 11, 2016 Category: Journals (General) Source Type: news
Follow-Up Essential After Endovascular AAA Repair Follow-Up Essential After Endovascular AAA Repair
Compared to an open approach, endovascular repair (EVAR) of abdominal aortic aneurysm (AAA) offers early survival benefit but shows inferior late survival, according to UK researchers.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - October 31, 2016 Category: Radiology Tags: Neurology & Neurosurgery News Source Type: news
Gore wins Medicare add-on status for Excluder stent graft
W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis.
Set to go into effect Oct. 1, the change will allow facilities that use the device, in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, to be eligible for a new tech add-on payment of up to $5,250 per case. The payment will come in addition to the applicable base payment for the Medicare Severity Diagnosis-related group.
“Prior to the IBE, there were limited options for maintaining blood flow to the inter...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Stent Grafts Vascular Reimbursement W.L. Gore & Associates Source Type: news
Consuming fewer calories reduces the risk of abdominal aortic aneurysm, study suggests
Mice placed on a low-calorie diet are less likely to develop abdominal aortic aneurysms, according to a new stud. The paper suggests new ways to prevent the often fatal condition from occurring in humans. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - September 26, 2016 Category: Science Source Type: news
Does Adding Epidural to General Anesthesia Improve Survival in AAA Repair? Does Adding Epidural to General Anesthesia Improve Survival in AAA Repair?
Combining epidural and general anesthesia for abdominal aortic aneurysm repair is associated with improved survival and lower risk of complications, according to a recent study. But the associations may not hold up in the real world, other researchers suggest.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 19, 2016 Category: Surgery Tags: Emergency Medicine News Source Type: news
Essential Medical closes $14.9M Series B for vascular closure device
Essential Medical said today that it closed a $14.9 million Series B round to support the development and commercialization of its vascular closure devices.
The round was led by Amzak Health and joined by prior backer Royal DSM venture investment arm DSM Venturing, the Malvern, Pa.-based company said.
“We are thrilled that Amzak Health has the confidence in the novel Essential Medical technology and our team to lead this round of financing along with our original investors. The Amzak group will also provide additional expertise and experience to our board of directors as our company transitions to commercialization ...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Vascular Essential Medical Devices Source Type: news
Research note: Predicting a deadly heart condition that runs in families
In 2015, Yale researchers developed a strategy for detecting silent but deadly aortic aneurysms — areas of enlargement in arteries — that appear to run in families. Now, professor of surgery John A. Elefteriades and his colleagues report that life-threatening tears in the aorta, or dissections, that result from aneurysms tend to occur in family members at roughly the same age. (Source: Yale Science and Health News)
Source: Yale Science and Health News - August 25, 2016 Category: Universities & Medical Training Tags: Yale News Source Type: news
Serious Heart Problem a Family Matter
If a relative has had an aortic dissection, you could too, study says
Source: HealthDay
Related MedlinePlus Pages: Aortic Aneurysm, Family History (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - August 25, 2016 Category: Consumer Health News Source Type: news
Endologix touts 1st Ovation Alto stent graft implantations
Endologix (NSDQ:ELGX) last week announced that its Ovation Alto abdominal stent graft system has been used in its 1st 2 procedures to treat abdominal aortic anneurysms.
The procedures were performed at New Zealand’s Auckland City Hospital by Dr. Andrew Holden and Dr. Andrew Hill, the Irvine, Calif.-based company said.
“The 1st patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a wide range of a...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Surgical Vascular Endologix Inc. Source Type: news
Drinking green tea to prevent artery explosion: Polyphenol intake reduces abdominal aneurysm expansion in rats
Green tea could prevent a deadly condition in the body ' s main artery. A team has found that abdominal aortic aneurysm -- a condition in which the main artery becomes overstretched and bloated -- developed less frequently in rats that drank green tea polyphenol, a major component of green tea. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 23, 2016 Category: Science Source Type: news
Lombard Medical exits U.S. market, shares jump
Lombard Medical Technologies (NSDQ:EVAR) said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft.
Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn.
Irvine, Calif.-based Lombard said it plans to focus exclusively on the European Union, Japan and other “key” international markets. The company in June won CE Mark approval in the European Union for the IntelliFlex device....
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic MassDevice Earnings Roundup Stent Grafts Wall Street Beat Lombard Medical Technologies Source Type: news
Quality assurance report: observations and recommendations from the visit to Central England on 2 February 2016
Public Health England (PHE) - This document presents the executive summary of the quality assurance report to the NHS abdominal aortic aneurysm screening programme in Central England.Summary reportPHE publications (Source: The Kings Fund - Health Management Specialist Collection)
Source: The Kings Fund - Health Management Specialist Collection - August 16, 2016 Category: Health Management Authors: The King ' s Fund Information & Knowledge Service Tags: Quality of care and clinical outcomes Regulation, governance and accountability Source Type: news
Discovery's Edge: New Stents for Complex Aortic Aneurysms
175,000 deaths are reported each year around the world, due to aortic aneurysms. When the largest blood vessel in the body, the aorta, dilates like an overstretched balloon it can be life-threatening. Mayo Clinic vascular surgeon Gustavo Oderich, M.D., and his team are helping to develop new stents for complex aortic aneurysms and recently used [...] (Source: Mayo Clinic Research News)
Source: Mayo Clinic Research News - August 8, 2016 Category: Research Source Type: news
