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

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

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

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 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

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

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

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

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

Endovascular Repair of Abdominal Aortic Aneurysm Endovascular Repair of Abdominal Aortic Aneurysm
How might endovascular aneurysm repair benefit patients with abdominal aortic aneurysm who are physically frail and ineligible for open repair?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 15, 2017 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

Endovascular Versus Open Repair of Abdominal Aortic Aneurysms Endovascular Versus Open Repair of Abdominal Aortic Aneurysms
Dr Lowenfels comments on a report, published in Surgery, that compares the two procedures for AAA. What have we learned to date?Medscape General Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 14, 2017 Category: Consumer Health News Tags: General Surgery Viewpoint Source Type: news

Endovascular Repair of Ruptured AAA Improves Midterm Survival Endovascular Repair of Ruptured AAA Improves Midterm Survival
Endovascular repair of ruptured abdominal aortic aneurysm was linked to reduced mortality at 3 years, improved early quality of life, and reduced costs compared with open surgery in the IMPROVE trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 20, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Metformin and Growth Rate of Abdominal Aortic Aneurysms Metformin and Growth Rate of Abdominal Aortic Aneurysms
Dr Lowenfels comments on a study that investigated whether metformin could significantly slow the growth rate of this very common disease.Medscape General Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 16, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery Viewpoint Source Type: news

Abdominal Aortic Aneurysm (Symptoms, Repair, Surgery, Survival Rate)
Title: Abdominal Aortic Aneurysm (Symptoms, Repair, Surgery, Survival Rate)Category: Diseases and ConditionsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 11/15/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - November 15, 2017 Category: Cardiology Source Type: news

Abdominal aortic aneurysm linked to dysregulated tryptophan metabolism, study finds
(Georgia State University) Researchers have found a link between dysregulated tryptophan metabolism and abdominal aortic aneurysm, a life-threatening vascular disease, according to a new study led by Georgia State University. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 13, 2017 Category: International Medicine & Public Health Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints ...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

This Device Has Been Around for 20 Years
It comes in different sizes and configurations now, but the Gore Excluder AAA Endoprosthesis, which seals off abdominal aneurysms from inside the aorta, hasn’t changed radically since it was introduced to the European market in 1997. The endovascular aneurysm repair (EVAR) device has been implanted in more than 300,000 patients diagnosed with an abdominal aortic aneurysm (AAA), according to its manufacturer, W.L. Gore & Associates. Before EVAR, patients with AAA had two options: major surgery to repair the aneurysm or crossed fingers. “The number of patients who were not candidates for surgery really drove ...
Source: MDDI - October 13, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Implants Design Source Type: news

Medtronic breaks ground on western China Innovation Center
Medtronic (NYSE:MDT) said today it has begun work on an Innovation Center in Chengdu, China, slated to open in 2020. The new Chengdu Innovation Center is being built at the Singapore-Sichuan Hi-Tech Innovation Park in the Sichuan Province and aims to provide clinical training and research platforms for medical workers in the region and neighboring regions. “Medtronic understands the critical role that rural physicians play in driving the healthcare availability and transformation. As such, we hope to support the growth and development of medical workers in China’s vast central and western regions, help the...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Medtronic Source Type: news

Medtronic wins expanded FDA nod for Endurant II stent graft
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies. Prior to receiving the clearance, patients with short infra-renal necks were classified as ineligible for endovascular aneurysm repair, the Fridley, Minn.-based company said. Medtronic estimates that 10-13% of AAA patients have AAA proximal neck anatomies of lower than or equal to 10mm. “Due to the complex and hostile proximal ao...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stents Vascular Medtronic Source Type: news

Endologix wins refined CE Mark indications for Nellix stent graft
Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use. The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical performance requirements. “We are very pleased with the clinical outcomes generated by the Nellix EndoVascular Aneurysm Sealing System utilizing the refined IFU. The Nellix CE Mark with the refined IFU provides patients and physicians in Europe ...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular Endologix Source Type: news

Lombard touts expected 50% cost reduction in restructuring effort
Lombard Medical Technologies (NSDQ:EVAR) said today it completed a restructuring of its business after implementing a plan to focus its sales efforts on the UK, Japan and China, as well as reducing operating and manufacturing costs as it seeks to breakeven with its cash flow. The UK-based company said that the restructuring is expected to result in a reudction of nearly $12 million in operating expenses next year when compared to last years expenditure levels, with costs reduced more than 50%. “During 2017, we have refocused sales and marketing activities in an effort to concentrate on our highest margin markets...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News lombardmedical MicroPort Scientific Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 14, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. How Boston Scientific is boosting medical device value Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data
Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair. The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease. Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials Distribution Research & Development Stents Vascular Endologix Source Type: news

Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial
Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system. The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy differences, including more angulated aortic necks and smaller aneurysms and iliac vessels. The analysis included 1,263 patients, with 133 female and 1,130 males. For women in the study, data indicated a 99.2% rate of successful delivery and eployment, only 0....
Source: Mass Device - September 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news

Canadian task force shifts gears on AAA screening
Ultrasound screening for abdominal aortic aneurysms (AAA) may see an uptick...Read more on AuntMinnie.comRelated Reading: USPSTF to take another look at AAA screening SPECT/CT tracer shows promise for AAA risk evaluation 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 - September 11, 2017 Category: Radiology Source Type: news

Does alcohol affect the risk of developing an abdominal aortic aneurysm?
(Wiley) In an analysis of published studies, lower levels of alcohol consumption were associated with a lower risk of abdominal aortic aneurysm until approximately 15 to 20 g/day, with an increasing risk thereafter. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - September 7, 2017 Category: International Medicine & Public Health Source Type: news

' Triple' Screening for AAA, PAD, High BP Reduces Mortality'Triple' Screening for AAA, PAD, High BP Reduces Mortality
Results of the VIVA trial show that a program of three screening tests--for abdominal aortic aneurysm, peripheral arterial disease, and hypertension--resulted in a significant reduction in all-cause mortality at 5 years.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 31, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Screening for vascular disease saves one life for every 169 patients assessed (VIVA)
(European Society of Cardiology) A novel screening program for vascular disease saves one life for every 169 men assessed, according to late-breaking results from the VIVA trial presented today in a Hot Line LBCT Session at ESC Congress and published in the Lancet. The combined screening for abdominal aortic aneurysm, peripheral artery disease, and hypertension gained more living years for lower costs than European cancer screening programs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 28, 2017 Category: International Medicine & Public Health Source Type: news

UCLA Health hospitals place No. 1 in Los Angeles, No. 7 nationally in prominent ranking
UCLA Health hospitals in Westwood and Santa Monica placed No. 1 in Los Angeles, No. 2 in California and No. 7 in the nation in the 2017 –18 U.S. News and World Report rankings.“UCLA Health is proud to be recognized for providing world-class treatment to patients from greater Los Angeles, across the state and around the globe,” said Johnese Spisso, president ofUCLA Health, CEO of UCLA Hospital System and associate vice chancellor of UCLA Health Sciences. “Our long-standing commitment to excellence ensures that our patients and their families receive the most compassionate, comprehensive care possible...
Source: UCLA Newsroom: Health Sciences - August 8, 2017 Category: Universities & Medical Training Source Type: news