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
Medtronic touts 3-year Heli-FX EndoAnchor registry study data
Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies.
Results from the trial were presented by co-principal investigator Dr. William Jordan of the Emory University School of Medicine at the 45th Annual Symposium of Vascular and Endovascular Issues in New York, the Fridley, Minn.-based company said.
“Hostile aortic necks are frequently seen in clinical practice and h...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular Medtronic Source Type: news
Vivasure Medical launches PerQseal closure system in the EU
Ireland-based Vivasure Medical said today it launched its PerQseal closure device intended for large-bore transcatheter procedures.
The newly launched device is intended for novel transcatheter endovascular procedures including transcatheter aortic valve replacements, thoracic endovascular aneurysm repairs and endovascular abdominal aneurysm repairs, which require large-bore femoral artery access. The system consists of an intravascular patch to seal the vessel from the inside.
Vivasure Medical touted the PerQseal as the first sutureless, fully absorbable synthetic implant for large bore arterial punctures.
“Closing...
Source: Mass Device - November 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Vivasure 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
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
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
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?
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.
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
FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts FDA Issues Leak Safety Alert for Endologix AAA Repair Grafts
Regulators say the company ' s AFX endovascular graft system with Strata material -- used for abdominal aortic aneurysm repair -- is at greater risk for type III endoleaks compared with other devices for the same indication.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 19, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
FDA Panel Backs Aortic Aneurysm Repair Device
(MedPage Today) -- Incraft stent graft system safe and effective, committee members say (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 13, 2018 Category: American Health Source Type: news
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients.
The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy.
“With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news
After Many Missteps, Endologix Makes Progress on Nellix
Endologix just took a big step forward on what has been a long and winding road to FDA approval of its Nellix endovascular aneurysm sealing (EVAS) system. The Irvine, CA-based company said the first patient was treated in its EVAS2 confirmatory clinical study of the device.
The Nellix System was developed as an alternative treatment to traditional endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA). The system is designed to seal an entire aneurysm.
Endologix originally planned to have FDA approval of the Nellix system by the end of 2016, but the company hit a speed bump about midway through that yea...
Source: MDDI - March 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Regulatory and Compliance Source Type: news
Study compares countries' mortality rates after aneurysm surgery
(Wiley) There is substantial international variation in mortality rates after treatment for abdominal aortic aneurysm, or enlargement of the aorta. A BJS (British Journal of Surgery) study that compared 10-year data from England and Sweden found that mortality rates were initially better in Sweden but improved over time alongside greater use of a minimally invasive procedure called endovascular aneurysm repair in England. Now there is no difference between postoperative mortality rates after aneurysm repair in England and Sweden. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 22, 2018 Category: International Medicine & Public Health Source Type: news
