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, d...
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 addressi...
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...
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 o...
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, ...
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 investiga...
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 n...
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

Study Supports Newest Indication for IL6R Blockade in Giant Cell Arteritis Study Supports Newest Indication for IL6R Blockade in Giant Cell Arteritis
New research confirms the association of a common variant in the gene that encodes the receptor for IL-6 with reduced risk for aortic aneurysm and supports the newest indication for IL6R blockade, giant cell arteritis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 17, 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 deliv...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Racing to treat an aortic aneurysm
Robert Palmer ’s passion is racing cars. But all that was interrupted by a difficult diagnosis. (Source: Yale Science and Health News)
Source: Yale Science and Health News - August 8, 2018 Category: Universities & Medical Training Source Type: news

Ciprofloxacin May Up Likelihood of Aortic Dissection, Rupture
FRIDAY, Aug. 3, 2018 -- In a mouse model of moderate, sporadic aortic aneurysm and dissection (AAD), ciprofloxacin increases susceptibility to aortic dissection and rupture, according to a study published online July 25 in JAMA Surgery. Scott A.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 3, 2018 Category: Pharmaceuticals 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

The dark side of antibiotic ciprofloxacin
(Baylor College of Medicine) Researchers have found that ciprofloxacin, a widely prescribed antibiotic, increases the risk of tears and rupture on the main artery of the body, the aorta, in a mouse model of human aortic aneurysms and dissections, a disease that carries high risk of death from aortic rupture. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 25, 2018 Category: International Medicine & Public Health 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 p...
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

Benefit May Not Outweigh Harm in AAA Screening Benefit May Not Outweigh Harm in AAA Screening
Swedish study finds screening for abdominal aortic aneurysm has no statistically significant effect on mortality, suggesting that other factors play a part in AAA incidence and death.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 27, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Opioids and OD; Test for Diabetes: It's PodMed Double T! (with audio)
(MedPage Today) -- This week's topics include the emotional consequences of gun violence, a single test to diagnose diabetes, use of medicines to help addiction after opioid overdose, and screening for abdominal aortic aneurysm (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - June 23, 2018 Category: Psychiatry 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

Routine Aortic Aneurysm Screening Questioned
(MedPage Today) -- No mortality benefit in recent years, according to Swedish registry (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 15, 2018 Category: Cardiology Source Type: news

Value of AAA screening drops as smoking declines
Mortality from abdominal aortic aneurysms (AAAs) has dropped sharply over the...Read more on AuntMinnie.comRelated Reading: POCUS helps medical students find more AAAs than surgeons USPSTF to take another look at AAA screening Current AAA screening strategies may miss the mark Vascular surgery society cautions use of US in AAA USPSTF finalizes AAA screening recommendations (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - June 15, 2018 Category: Radiology Source Type: news

Cardinal Health deals majority stake in NaviHealth to PE shop CD & R
Cardinal Health (NYSE:CAH) said this week it divested itself of its majority stake in NaviHealth to private equity firm Clayton, Dubilier & Rice, with Cardinal Health retaining the call right to reacquire the business. NaviHealth provides post-acute car programs to hospital systems, health planst, physician groups and healthcare providers as part of value-based care programs, Cardinal Health said. Through the deal, CD&R will obtain a 55% ownership stake in NaviHealth, while Dublin, Ohio-based Cardinal Health will retain an approximate 45% stake in the post-acute care focused business. “This new investmen...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Cardinal Health Source Type: news

Screen Does Not Cut Abdominal Aortic Aneurysm Mortality in Men
FRIDAY, June 15, 2018 -- Screening men for abdominal aortic aneurysm (AAA) does not reduce AAA-related mortality, according to a study published in the June 16 issue of The Lancet. Minna Johansson, M.D., from the University of Gothenburg in Sweden,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 15, 2018 Category: Pharmaceuticals Source Type: news

Screening for aortic aneurysms in older men questioned
(University of Gothenburg) Screening programs for aortic aneurysms in the abdomen is now being questioned in a study published in The Lancet. As the condition becomes less common, general ultrasound scans for 65-year-old men may do more harm than good, the researchers assert. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 15, 2018 Category: International Medicine & Public Health Source Type: news

FDA panel backs Cardinal Health ’ s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system. The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced endovascular aneurysm system for treating infrarenal abdominal aortic aneurysms, the Dublin, Ohio-based company said. The Incraft AAA system differs from other EVAR systems as it is intended to treat a wider range of patients, as many EVAR devices are limi...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Stent Grafts Vascular Cardinal Health 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

Puerto Rico Issues New Data on Hurricane Maria Deaths
SAN JUAN, Puerto Rico (AP) — Eight days after Hurricane Maria devastated Puerto Rico, Efrain Perez felt a pain in his chest. Doctors near his small town sent him to Puerto Rico's main hospital for emergency surgery for an aortic aneurysm. But when the ambulance pulled into the parking lot in the capital, San Juan, after a more than two-hour drive, a doctor ran out to stop it. "He said, 'Don't bring him in here, I can't care for him. I don't have power. I don't have water. I don't have an anesthesiologist,'" Perez's daughter, Nerybelle, recalled. The 95-year-old Perez died as the ambulance drove him back to ...
Source: JEMS: Journal of Emergency Medical Services News - June 12, 2018 Category: Emergency Medicine Authors: Danica Coto, Associated Press Tags: Major Incidents News Category Source Type: news

Cardinal Health ’ s Cordis wins date with FDA panel for Incraft AAA stent graft
Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms. On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for the InCraft, which is currently under evaluation in the company’s Inspiration study. The Inspiration study has already met its primary safety and effectiveness endpoints, but reported a higher than anticipated ...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Cardinal Health Cordis Corp. Source Type: news

MicroPort Scientific buys Lombard Medical out of bankruptcy
Lombard Medical Technologies (NSDQ:EVAR) said today that it was acquired out of bankruptcy by MicroPort Scientific (HK:00853), which hopes to get Lombard’s stent grafts on the market in China. MicroPort put $15 million into Lombard back in December 2016 in a deal that aimed to accelerate the commercialization of Lombard’s Aorfix and Altura stent grafts for treating abdominal aortic aneurysms. Finalized in April 2017, the agreement called for MicroPort to make components for Aorfix and Altura at its facility in Shanghai and gave it exclusive marketing rights for Lombard products in China and Brazi...
Source: Mass Device - April 26, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Stent Grafts Wall Street Beat Lombard Medical MicroPort Scientific Source Type: news

Fruit fly study identifies new gene linked to aortic aneurysms
(Baylor College of Medicine) An interdisciplinary team of researchers has identified a new gene linked to human aortic aneurysms. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - April 24, 2018 Category: Biology Source Type: news

Terumo ’ s Vascutek, Bolton Medical merge to form Terumo Aortic
Terumo Corp. (TYO:4543) said today its Vascutek subsidiary and Bolton Medical have merged together to form a new company, Terumo Aortic. The newly combined company is expected to have a revenue of more than $200 million, and will employ more than 1,100 individuals worldwide, Tokyo-based Terumo said. Terumo Aortic will look to accelerate its position in treating aortic disease, the companies said, with primary research and manufacturing facilities in Glasgow, Scotland and Sunrise, Fla. The combined company’s portfolio will include surgical grafts for cardiothoracic, abdominal and peripheral applications...
Source: Mass Device - April 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Vascular Bolton Medical Terumo terumoaortic Source Type: news

Why you might think twice about wine with dinner
Having a single glass of wine with dinner every night could cut your life expectancy by about two years, according to an international study linking increased alcohol consumption with a higher risk of developing fatal diseases.   The research, published in the medical journal The Lancet, found that people who drank the equivalent of about six glasses of wine a week or more increased their risk of stroke, heart disease, heart failure, fatal hypertensive disease and fatal aortic aneurysm. The researchers… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 13, 2018 Category: Pharmaceuticals Authors: Anne Stych Source Type: news

Why you might think twice about wine with dinner
Having a single glass of wine with dinner every night could cut your life expectancy by about two years, according to an international study linking increased alcohol consumption with a higher risk of developing fatal diseases.   The research, published in the medical journal The Lancet, found that people who drank the equivalent of about six glasses of wine a week or more increased their risk of stroke, heart disease, heart failure, fatal hypertensive disease and fatal aortic aneurysm. The researchers… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 13, 2018 Category: Biotechnology Authors: Anne Stych 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

7 medtech stories we missed this week: March 23, 2018
[Image from unsplash.com]From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. As part of the agreement, Innovasource will be leading the evaluation of the AsepticSure system and compare it to existing cleaning practices in a number of facilities and settings. AsepticSure is desig...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Food & Drug Administration (FDA) Hospital Care Imaging Implants Patient Monitoring Regulatory/Compliance Respiratory advantismedicalimaging aziyobiologics Balt endospan Medizone MedTech Olympus Respiratory Motion 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

Endologix launches study of second-gen Nellix endovascular aneurysm sealing system
Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system. The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a number of markets around the world. The first patient in the company’s confirmatory IDE study was treated by Dr. Sajjad Hussain at St. Vincent Heart Center in Indiana. The EVAS2 trial is slated to enroll up to 90 patients and follow their progress o...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Wall Street Beat Endologix 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

Medtronic launches Abre stent iliofemoral venous outflow obstruction IDE study
Medtronic (NYSE:MDT) said today it launched an FDA investigational device exemption study of its Abre venous self-expanding stent system, looking to explore the use of the device in subjects with iliofemoral venous outflow obstruction. The first procedure in the study was performed last month by national principal investigator Dr. Erin Murphy of Charlotte, N.C.’s Sanger Heart & Vascular Institute, the Fridley, Minn.-based company said. “The launch of the Abre IDE Study marks the beginning of an important journey to establish new options for the treatment of deep venous disease. The first procedure...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Medtronic Source Type: news

Medtronic launches Endurant II, IIs ChEVAR real-world study
Medtronic (NYSE:MDT) said today it launched a study of its Endurant II and IIs stent graft systems, designed to treat abdominal aortic aneurysms, exploring the use of the device in ChEVAR procedures in real-world settings. The 150-patient, single-arm study is slated to enroll patients at 25 sites across Europe and Russia, with the first enrollments already underway at Munster, Germany’s St. Franziskus Hospital led by principal investigator Dr. Giovanni Torsello. “We are excited to initiate this study in a real-world population, which will build upon existing clinical evidence for the ChEVAR technique as a ...
Source: Mass Device - January 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news

Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study. The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee. “Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment. The angulation control in the new delivery system for the Gore Excluder Co...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular W.L. Gore & Associates Source Type: news