Sex Disparity in Abdominal Aortic Aneurysm Repair Outcomes Sex Disparity in Abdominal Aortic Aneurysm Repair Outcomes
Do sex-related differences exist in mortality after repair of ruptured abdominal aortic aneurysm? Is the timeliness of repair a factor?Annals of Surgery (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 25, 2019 Category: Surgery Tags: General Surgery Journal Article Source Type: news
Endologix Takes a Step Forward with Nellix IDE
Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney Endovascular Aneurysm Sealing System for the endovascular treatment of complex abdominal aortic aneurysms (AAA).
The system is an endovascular abdominal aortic aneurysm therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxta-renal, para-renal, and suprarenal AAA. The application of endovascular aneurysm sealing for patients with complex aneurysms will offer innovativ...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news
USPSTF Recommends Screening Older Men Who Smoked for AAA
On June 18, the U.S. Preventive Services Task Force posted a draft recommendation statement on screening for abdominal aortic aneurysm in asymptomatic patients. Men ages 65-75 who smoke or used to smoke benefit most from screening; the task force recommends one-time screening with ultrasonography in this group. (Source: AAFP News)
Source: AAFP News - July 8, 2019 Category: Primary Care Source Type: news
USPSTF Addresses Screening for Abdominal Aortic Aneurysm
TUESDAY, June 18, 2019 -- The U.S. Preventive Services Task Force (USPSTF) recommendations on screening for abdominal aortic aneurysm (AAA) vary with sex, age, smoking status, and family history. These recommendations form the basis of a draft... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 18, 2019 Category: Pharmaceuticals Source Type: news
GMED Reinstates CE Mark for Endologix Nellix System
Endologix reported a huge regulatory win this week.
The Irvine, CA-based company said its CE mark for the Nellix EndoVascular Aneurysm Sealing System has been reinstated, allowing the device to return to the European market. In January, Endologix initiated a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The company decided to limit the device to use under clinical protocol with pre-screened patients that adhere to the current indications. The company's CE mark for the Nellix system was subsequently suspended. Endologix said the reinstateme...
Source: MDDI - June 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Long-Term Survival Similar for Endovascular, Open AAA Repair
WEDNESDAY, May 29, 2019 -- For patients with asymptomatic abdominal aortic aneurysm, long-term overall survival is similar with either endovascular repair or open repair, according to a study published in the May 30 issue of the New England Journal... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 29, 2019 Category: Pharmaceuticals Source Type: news
Adult Health Screening
This report summarises evidence on the management of four screening programmes in England: bowel cancer, breast cancer, cervical cancer and abdominal aortic aneurysm. The report finds that the Department of Health and Social Care, NHS England and Public Health England are not doing enough to make sure that everyone who is eligible to take part in screening is doing so, and do not know if everyone who should be invited for screening has been (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 13, 2019 Category: Consumer Health News Source Type: news
Virtual reality engages patients more than CT, booklets
Patients with an abdominal aortic aneurysm were more engaged and had a better...Read more on AuntMinnie.comRelated Reading:
4 practical applications of VR, AR in radiology
SIR: Virtual reality beats fluoroscopy for catheter placement
VR, AR elevate radiologists' value in future of medicine
Virtual reality may help plan, guide glioma resection
VR software may increase MRI segmentation efficiency (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 25, 2019 Category: Radiology Source Type: news
Endologix readies for 1-for-10 reverse split
Endologix (NSDQ:ELGX) said yesterday that its board of directors set the ratio for its reverse stock split at 1-for-10.
Beginning today, Endologix’s common stock will trade on the Nasdaq Global Select market on a reverse stock split-adjusted basis, the Irvine, Calif.-based company reported.
Following the reverse split, there will be roughly 10.3 million shares of issued and outstanding common stock, according to Endologix. The company’s stock will continue to trade under the ‘ELGX’ ticker.
In February, Endologix posted fourth-quarter and full-year results that missed sales and earnings estimates on...
Source: Mass Device - March 6, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Stent Grafts Wall Street Beat Endologix Source Type: news
Endologix misses the mark with Q4, 2018 numbers
The objectives we accomplished during the second half of 2018 align with those we laid out during our second-quarter earnings call as part of our strategic reset. As we enter 2019, our single biggest lever will be a consistent and unwavering application of individual and company-wide accountability. We will lean heavily on this lever throughout the year as the critical enabler of consistent delivery on our commitments to patients, customers, investors and other stakeholders. We are determined to sustain the momentum generated over the last two quarters as we continue to take steps to improve the company’s operational...
Source: Mass Device - February 27, 2019 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Stent Grafts Wall Street Beat Endologix Source Type: news
How Endologix Is Winning Customers Back One Procedure at a Time
Endologix might not be out of the woods yet, but the company does appear to be moving in the right direction.
"We are shifting from a defensive position to an offensive position," CEOÂ John Onopchenko said during the company's fourth-quarter earnings call on Monday, as transcribed by Seeking Alpha.
The company reported sequential sales growth of its Ovation system in the fourth quarter, which management said gives them confidence that the platform will return Endologix to growth in the second half of 2019.
But to fully appreciate that projection, investors have to look back at where the Irvine, CA-based company ...
Source: MDDI - February 26, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Why 20% of men ignore the test that'll stop them dropping dead?
Abdominal aortic aneurysm, or AAA, is a swelling of the body’s biggest blood vessel, the aorta, which runs directly from the heart to the lower body. If it bursts, 8 out of 10 victims die. (Source: the Mail online | Health)
Source: the Mail online | Health - February 10, 2019 Category: Consumer Health News Source Type: news
Why 20% of men ignore the test that'll stop them dropping dead?
Abdominal aortic aneurysm, or AAA, is a swelling of the body ’s biggest blood vessel, the aorta, which runs directly from the heart to the lower body. If it bursts, 8 out of 10 victims die. (Source: the Mail online | Health)
Source: the Mail online | Health - February 10, 2019 Category: Consumer Health News Source Type: news
Endologix ’s CE Mark for Nellix is Suspended
It looks like more bad news for Endologix. The Irvine, CA-based company said its CE Mark for the Nellix EndoVascular Aneurysm Sealing System has been suspended by its Notified Body, GMED. Endologix first received approval in Europe for the device in 2013.
The Nellix system was developed as an alternative treatment to traditional endovascular aneurysm repair for an abdominal aortic aneurysm. The system is designed to seal an entire aneurysm.
“The notification from GMED is a regulatory action and is not in response to any new information beyond our recent FSN,†Dr. Matt Thomps...
Source: MDDI - January 25, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
Endologix Voluntarily Recalls Nellix
Endologix said it was initiating a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications.
Endologix said it was taking these steps in order to ensure optimal outcomes for patients. This decision is one of several actions taken by Endologix following a new management mandate in August 2018 to ensure the most appropriate use of each of its devices and is in alignment with a recent publication by the European...
Source: MDDI - January 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
