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
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
FDA Warns of Aortic Aneurysm Risk With Fluoroquinolones FDA Warns of Aortic Aneurysm Risk With Fluoroquinolones
The agency is advising healthcare providers avoid prescribing the powerful antibiotics in certain patients, citing nearly twice the risk of aortic aneurysm.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 20, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
Certain antibiotics may cause aortic aneurysm, FDA warns
The US Food and Drug Administration warned on Thursday that the benefits of fluoroquinolone antibiotics do not outweigh the risks -- which include aortic aneurysm -- for certain patients, according to the latest research. The research is based on reports of patient problems and on studies published between 2015 and 2018. (Source: CNN.com - Health)
Source: CNN.com - Health - December 20, 2018 Category: Consumer Health News Source Type: news
FDA Warns on Aortic Aneurysms With Fluoroquinolones
(MedPage Today) -- Adds to already long list of issues with popular antibiotic class (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 20, 2018 Category: American Health 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
Medtronic wins CE Mark for Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today it received CE Mark in the European union for its Valiant Navion thoracic stent graft system intended for use in minimally invasive procedures to repair lesions in the descending aorta.
The Fridley, Minn.-based company said that the device is cleared for use in treating thoracic aortic aneurysms, blunt traumatic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and type B aortic dissections.
The Valiant Navion is a low-profile version of the company’s Valiant Captivia thoracic stent system, and features both CoveredSeal and FreeFlo stent configurations. Medtronic ...
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance Stent Grafts Vascular 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
FDA approves Medtronic ’ s Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta.
The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections.
Medtronic said that the newly cleared Valiant Navion stent will enable patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs, and will open pe...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance Stent Grafts Stents Vascular Medtronic Source Type: news
Endologix Broadens Recall to All AFX Endovascular AAA Systems Endologix Broadens Recall to All AFX Endovascular AAA Systems
The company is recalling all AFX endovascular aortic aneurysm systems after continued problems with type III endoleaks. The FDA has now classified the recall as class I, the most serious designation.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 16, 2018 Category: Consumer Health News Tags: Cardiology News Alert 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
