Endologix recalls Nellix stent graft, bans off-label use
Endologix (NSDQ:ELGX) said today that it’s halting the unrestricted sale of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol.
“We monitor the performance of the Nellix system through clinical trials, our complaint monitoring system, physician interaction and available publications,” CMO Dr. Matt Thompson said in prepared remarks. “Our independently adjudicated data from the EVAS1 IDE clinical trial indicates that the Nellix system has performed well when used consistent with the current indications. However, data ...
Source: Mass Device - January 4, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Recalls Regulatory/Compliance Stent Grafts Endologix Source Type: news
Aortica touts FDA clearance to use Medtronic ’ s Valiant Navion in AAA IDE study
Aortica said today that the FDA approved the use of Medtronic‘s (NYSE:MDT) Valiant Navion stent graft system alongside Aortica’s AortaFit in a physician sponsored IDE study.
The study, being run by principal investigator Dr. Benjamin Starnes at the University of Washington, will now use the Valiant Navion as a platform for fenestrated endovascular repair together with the AortaFit automated case planning software.
“I am excited to bring Medtronic’s Navion into this study. The device architecture incorporates many of the features we feel are important to simplifying fenestrated EVAR and addressing many ...
Source: Mass Device - December 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Vascular Aortica Medtronic Source Type: news
In Abdominal Aortic Aneurysm Repair, Curcumin Lacks Benefit
FRIDAY, Nov. 9, 2018 -- When used perioperatively in elective abdominal aortic aneurysm repair, curcumin has no beneficial effect, according to a study published in the Oct. 29 issue of CMAJ, the journal of the Canadian Medical Association.
Amit X.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 9, 2018 Category: Pharmaceuticals Source Type: news
Cardinal Health ’ s Cordis launches Mynx Control vascular closure system
Cardinal Health (NYSE:CAH) subsidiary Cordis said last Friday that it launched the Mynx Control vascular closure device intended for sealing 5-7 French femoral arterial access sites.
The newly launched system is intended to reduce time to hemostasis and ambulation after diagnostic or interventional procedures, the Dublin, Ohio-based company said. The system also includes a next-generation deployment system designed to improve predictable deployment.
“The notion of secure extravascular closure with nothing left behind is very appealing for a number of reasons. In addition to the clinical benefits of undisrupted fl...
Source: Mass Device - November 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Cardinal Health Cordis Corp. Source Type: news
No Benefit of Curcumin in Abdominal Aortic Aneurysm Repair No Benefit of Curcumin in Abdominal Aortic Aneurysm Repair
Perioperative oral curcumin does not prevent inflammation or complications in patients undergoing elective abdominal aortic aneurysm repair and may increase risk of postoperative kidney injury.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 1, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
Nick Foster obituary
My father, Nick Foster, who has died aged 61 after suffering a ruptured abdominal aortic aneurysm, was an agricultural engineer devoted to improving conditions for rural people in the developing world.He wanted to empower communities by encouraging participation and education, and established water-user groups that led to the sustainable management of irrigation schemes.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - October 15, 2018 Category: Science Authors: Patrick Foster-Devaney Tags: Agriculture Access to water Bangor University Source Type: news
FDA: Endologix recall of AFX stent graft is Class I
Endologix (NSDQ:ELGX) said late last week that the FDA classified its voluntary recall of AFX Endovascular abdominal aortic aneurysm stent graft systems as Class I.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Irvine, Calif.-based company said it issued its recall action in July, sending safety notices to healthcare professionals who use the system. The notice included updated information on comparative Type III endoleak rates associated with the device, as well ...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Recalls Regulatory/Compliance Vascular Endologix Source Type: news
Teleflex picks up Essential Medical and its Manta vascular closure device
Teleflex (NYSE:TFX) said yesterday that it acquired Essential Medical and its Manta vascular closure device for an unspecified amount.
Manta is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasties.
Exton, Pa.-based Essential won CE Mark approval in the European Union for Manta in July 2016 and is seeking pre-market approval from the FDA. The federal safety watchdog granted an investigational device exemptionÂ...
Source: Mass Device - October 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Vascular Wall Street Beat Essential Medical Devices Teleflex Source Type: news
Statins Improve Long-Term Survival After AAA Repair
THURSDAY, Sept. 20, 2018 -- Preoperative statin therapy is associated with higher long-term survival following abdominal aortic aneurysm (AAA) repair, according to a study published in the August issue of the Journal of Vascular Surgery.
Thomas F.X.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 20, 2018 Category: Pharmaceuticals Source Type: news
Gore ’s aneurysm device for tricky anatomies implanted in Europe
(Image courtesy of W.L. Gore & Associates)
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates.
The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length and patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic neck leng...
Source: Mass Device - September 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Implants Surgical W.L. Gore & Associates Source Type: news
Personal Genome Can Predict Abdominal Aortic Aneurysm Risk Personal Genome Can Predict Abdominal Aortic Aneurysm Risk
Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 12, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
Declining Sales Prompts Endologix to Hit the Strategic Reset Button
John Onopchenko has had his work cut out for him since being promoted to CEO of Endologix in May.
The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selling device for abdominal aortic aneurysms (AAA). This and other issues led CEO John McDermott to resign earlier this year.
"The leadership team and I have been working hard on reestablishing Endologix's credibility and reputation with our physicians and customers and building a culture of accountability, with the ultimate goal of delivering...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Total, Open Repairs Decline for Abdominal Aortic Aneurysms
TUESDAY, July 31, 2018 -- The number of open abdominal aortic aneurysm (AAA) repairs dropped by almost 80 percent during the last decade, according to a study published in the June issue of the Journal of Vascular Surgery.
Bjoern D. Suckow, M.D.,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 31, 2018 Category: Pharmaceuticals Source Type: news
Out with the Old, in with the ... Newish?
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It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company.
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Endologix has had its fair share of hurdles over the past couple of years, but it seems like things might finally be looking up for the Irvine, CA-based company.
In May, the company promoted John Onopchenko to the role of CEO. Prior to the promotion, Onopchenko was the company's chief operating officer, a position he took in October 2017.
"At that time, ...
Source: MDDI - July 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Benefit of Screening for Abdominal Aortic Aneurysm May Not Outweigh Harms Benefit of Screening for Abdominal Aortic Aneurysm May Not Outweigh Harms
Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - July 5, 2018 Category: Radiology Tags: Cardiology News Source Type: news
