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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

Medical News Today: Ascending aortic aneurysm: Symptoms, causes, and treatments
What are the causes and risk factors of an ascending aortic aneurysm? What are the different types, how is it diagnosed and can it be prevented? (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - September 27, 2017 Category: Consumer Health News Tags: Cardiovascular / Cardiology 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

Aortic Aneurysm Risk Is Smaller in Type 2 Diabetes Patients Aortic Aneurysm Risk Is Smaller in Type 2 Diabetes Patients
"While it's good that people with diabetes may get less" aortic aneurysm, they still need to lower blood pressure, control lipids, and stop smoking to prevent overall cardiovascular risk, an expert noted.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 20, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News 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

T2D Tied to Less Aortic Aneurysm Risk
(MedPage Today) -- Does diabetes somehow strengthen vessel wall? (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - September 13, 2017 Category: Urology & Nephrology 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

Is Aortic Aneurysm Hereditary?
Title: Is Aortic Aneurysm Hereditary?Category: Doctor's& Expert's views on SymptomsCreated: 8/28/2017 12:00:00 AMLast Editorial Review: 8/28/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - August 28, 2017 Category: Cardiology 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

New imaging tracer allows early assessment of abdominal aortic aneurysm risk
(Society of Nuclear Medicine) Yale University researchers have developed a way in which medical imaging with SPECT/CT could potentially be used to assess a patient's rupture risk for abdominal aortic aneurysm. Delaying surgical treatment can be life-threatening, and this new type of imaging could allow physicians to diagnose disease and better plan its management. The study is presented in the featured article of the August issue of The Journal of Nuclear Medicine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 1, 2017 Category: International Medicine & Public Health Source Type: news

Northwestern, University of Calgary win $3m grant for cardiac valve imaging project
Patients who are born with a bicuspid aortic valve have 2 flaps in their cardiac valve instead of 3 – and researchers from Northwestern University and the University of Calgary are planning a 5-year study to evaluate an imaging approach for preventing the complications of this genetic condition. With a $3.3 million grant from the National Institutes of Health, the team plans to use 4D-Flow MRI to visualize 3D blood flow in real time and analyze tissue to develop a personalized treatment for patients with BAV. “Not all BAV patients are the same, yet they are currently treated the same when it comes to timing and...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Imaging National Institutes of Health (NIH) Northwestern University universityofcalgary Source Type: news

Aortica raises $1m, looks for $4m more
Aortica has raised $1 million in a new round of mixed financing, according to an SEC filing posted this week. Money in the round comes from 11 unnamed investors, with the 1st sale recorded on June 13 this year. The company is looking for an additional $3 million in the round before closing it, according to the SEC filing. Aortica has not yet stated how it plans to spend funds raised in the round. In February, Aortica said that midterm data from a physician-sponsored investigational device exemption trial was “highly favorable.” In the trial, researchers are examining physician-modified endovascular grafts for t...
Source: Mass Device - June 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Aortica Source Type: news

Skin cell model advances study of genetic mutation linked to heart disease, stroke risk
(UT Southwestern Medical Center) Using a new skin cell model, researchers have overcome a barrier that previously prevented the study of living tissue from people at risk for early heart disease and stroke. This research could lead to a new understanding of disease progression in aortic aneurysm -- ballooning of the large artery in the chest that carries blood from the heart to the body. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 26, 2017 Category: International Medicine & Public Health Source Type: news

Endologix touts low rate of endoleaks, mortality in 2-year Nellix study results
Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities. Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and Cooper Health System at the Society of Vascular Surgery’s 2017 Vascular annual meeting this week. “The overall 2-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stent Grafts Vascular Endologix Source Type: news

Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. “Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR. In many patients, it is imperative that iliac artery ...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular W.L. Gore & Associates Source Type: news

7 medtech stories we missed this week: May 19, 2017
[Image from unsplash.com]From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of th...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Body Vision Medical Exactech Inc. Lombard Medical Technologies MedTech NxThera Inc. Rivanna Medical Visionsense XpandOrtho Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 18, 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. Medtronic owes spine doc inventor $24m for patent infringement Medtronic must fork over nearly $24 million to the physician inventor behind a group of patents covering a technique for treating spine defects. Dr. Mark Barry sued...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Source Type: news

Endologix dives on 2-year setback for Nellix stent graft
Endologix (NSDQ:ELGX) shares were off more than 30% this morning after the company yesterday revealed a 2-year setback for its Nellix stent graft for repairing abdominal aortic aneurysms. Irvine, Calif.-based Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when the federal safety watchdog asked for 2-year follow-up data from the EVAS-Forward investigational device exemption study. Endologix said yesterday that the confirmatory study will aim to cover t...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Wall Street Beat Endologix Source Type: news

FDA: Fluoroquinolones Not Tied to Retinal Detachment, Aortic Aneurysm (FREE)
By the Editors Fluoroquinolones don't appear to cause retinal detachment or aortic aneurysm or dissection, the FDA said on Thursday as part of its ongoing safety review … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - May 12, 2017 Category: Primary Care Source Type: news

FDA: Fluoroquinolones Not Linked to Retinal Detachment FDA: Fluoroquinolones Not Linked to Retinal Detachment
Available evidence does not support reports that fluoroquinolone antibiotics may result in retinal detachment or aortic aneurysm or dissection, the FDA said.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 11, 2017 Category: Consumer Health News Tags: Ophthalmology News Alert Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 26, 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. Baxter sees shares lift on Street-beating Q1 earnings release Baxter shares have risen today after the medical device company topped expectations on Wall Street with its 1st quarter earnings results. The Deerfield, Ill.-based c...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 Charing Cross Symposium in London this week. “Medtronic aims to increase access to treatment for patients with aortic disease. This goal has been reinforced by our commitment to developing robust clinical programs – such as the Engage registry &ndas...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Endoscopic / Arthroscopic Stent Grafts Vascular Medtronic Source Type: news

Women Fare Poorly with Aortic Aneurysm
British study says their treatment, compared to men, needs drastic improvementSource: HealthDay Related MedlinePlus Pages: Aortic Aneurysm, Women's Health (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - April 26, 2017 Category: Consumer Health News Source Type: news

Women Fare Poorly With Aortic Aneurysm: Study
WEDNESDAY, April 26, 2017 -- Women with abdominal aortic aneurysms have far worse outcomes than men, and their treatment needs to be dramatically improved, British researchers report. An abdominal aortic aneurysm occurs when there is weakening and... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2017 Category: Journals (General) Source Type: news

Women Fare Poorly With Aortic Aneurysm: Study
Title: Women Fare Poorly With Aortic Aneurysm: StudyCategory: Health NewsCreated: 4/26/2017 12:00:00 AMLast Editorial Review: 4/26/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - April 26, 2017 Category: Cardiology Source Type: news

Women with aortic aneurysms fare much worse than men, new study finds
(Imperial College London) Mortality rates for women undergoing surgery for abdominal aortic aneurysms are nearly twice those for men, a new study has found. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - April 25, 2017 Category: Global & Universal Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 5, 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. Trumpcare’s prospects dim, but not too dim to hit stent graft makers The push on Capitol Hill to revive Trumpcare stalled yesterday, but not before the chatter out of Washington instigated a slide for stent graft makers&r...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Trumpcare ’ s prospects dim, but not too dim to hit stent graft makers
The push on Capitol Hill to revive Trumpcare stalled yesterday, but not before the chatter out of Washington instigated a slide for stent graft makers’ stocks. The Affordable Care Act covers a 1-time screening for abdominal aortic aneurysms in men who smoke or smoked in the past, listing the test as an “essential health benefit.” The GOP’s healthcare reform proposal would do away with the AAA screening coverage, shifting the cost of the test to patients, which could in turn affect AAA repair procedure volumes. Investors reacted by pushing share prices down yesterday on Wall Street for Lombard M...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Healthcare Reform Stent Grafts Wall Street Beat C.R. Bard Capitol Hill Endologix Lombard Medical Technologies Source Type: news

7 medtech stories we missed this week: March 31, 2017
[Image from unsplash.com]This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are 7 medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted PCI procedures were performed for the first time in Asia using the CorPath GRX system. The procedures were performed at Fu Wai Hospital. This is the first time the system has been used outside of the U.S. CorPath GRX enhances the precision and workflow of the...
Source: Mass Device - March 31, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Clinical Trials Food & Drug Administration (FDA) Robot-Assisted Surgery Robotics Stent Grafts Amniox Bodycad Corindus Endologix MedTech NeoSurgical NeoTract Providence Medical Tissuetech Source Type: news

Moderate drinking may reduce heart disease risk
Conclusion This study paints a more complicated picture than the "Pint a day keeps the doctor away" story proffered by The Sun. It seems to confirm the findings of other studies, which have shown that non-drinkers tend to have a higher risk of cardiovascular diseases than people who drink moderately. It suggests that some cardiovascular diseases (mainly those directly affecting the heart) seem to have a stronger link to a possible protective effect from alcohol than other vascular diseases, such as mini-strokes and bleeding in the brain. However, this can't be concluded with certainty due to the study design. We ...
Source: NHS News Feed - March 23, 2017 Category: Consumer Health News Tags: Heart/lungs Food/diet Lifestyle/exercise Source Type: news

Endologix faces shareholder suit over Nellix snafu
Endologix (NSDQ:ELGX) is facing a lawsuit from stockholders alleging the company miscommunicated and failed to disclose issues related to its Nellix EVAS stent graft designed for treating abdominal aortic aneurysms. The shareholders filed the suit in the US District Court for the Central District of California, representing individuals who purchased shares between Aug. 2, 2016 and Nov. 16, 2016, according to an SEC filing. The suing shareholders allege that the company made “materially false and misleading statements and failed to disclose material adverse facts about its business, operational and financial perf...
Source: Mass Device - March 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Legal News Endologix Inc. Source Type: news

MicroPort, undaunted by price caps, enters India ’ s stent market
MicroPort has entered the Indian market only days after the country’s National Pharmaceutical Pricing Authority imposed a price cap on coronary stents. The Shanghai-based company said its Firehawk Rapamycin target eluting coronary stent system was successfully used in a procedure in Mumbai earlier in the month, marking the 1st time the device saw use in the country. The procedure was performed at H. J. Doshi Ghatkopar Hindu Sabha Hospital in Mumbai, by Dr. Anil Potdar, according to a press release. The company touted the Indian market as having the 3rd largest amount of PCI cases in the world, and promised future exp...
Source: Mass Device - February 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Stents MicroPort Scientific Source Type: news

Endologix wins CE Mark reinstatement for AFX, AFX2, touts 3-year post market Ovation study
This study confirms the ability of the Ovation platform to successfully treat a broad array of patient anatomies with a high rate of treatment success and freedom from secondary intervention through mid-term follow-up. We are pleased to have revealed these impressive results at our scientific symposium this year,” study principal investigator Dr. Dierk Scheinert said in a prepared statement. “The addition of these European results continue to validate the excellent clinical results and durability of the ultra-low profile Ovation platform, further confirming the recently announced 5-year Ovation IDE study r...
Source: Mass Device - January 25, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Regulatory/Compliance Vascular Endologix Inc. Source Type: news

Endologix cuts outlook for 2017
Endologix is reportedly lowering its revenue growth outlook to flat- to low-single digits. The company has previously said it expects mid-single digit growth for 2017. The Irvine, Calif.-based company’s management commented on Endologix’s outlook at the 35th JP Morgan Healthcare Conference, according to a report from Leerink. The company has not made a formal statement regarding its guidance for 2017. The analyst wrote that Endologix is probably going to see further downward estimate revisions, especially given the regulatory and quality issues that came to light in December last year. The compan...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Vascular Wall Street Beat Endologix Inc. Source Type: news

Lombard wins Japanese clearance for IntelliFlex LP delivery device for Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its Intelliflex low profile delivery system for the Aorfix endovascular stent graft. The Oxfordshire, England-based company said it will initiate a commercial launch of the device in Japan once it receives reimbursement approval, expected some time next month. Currently, Medico’s Hirata has exclusive distribution rights to the Aorfix. “We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8% over the last two years. Now with t...
Source: Mass Device - January 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Lombard Medical Technologies Source Type: news

MassDevice.com +5 | The top 5 medtech stories for December 28, 2016
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. Precision Spine wins FDA 510(k) for AccuFit lateral plate system Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability. The Parsippany, N.J.-based com...
Source: Mass Device - December 28, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Endologix puts hold on AFX shipments over manufacturing issues
Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices. The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company. The hold came only weeks after Endologix had the CE Mark approval for the AFX system suspended over reports of type III endoleaks associated with a previous-gen version of the device. The Irvine, Calif.-based company expects the temporary hold to be lifted for some sizes “in the near future,&r...
Source: Mass Device - December 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance Vascular Endologix Inc. Source Type: news

China ’ s Microport puts $15m into Lombard Medical
Lombard Medical Technologies (NSDQ:EVAR) said today that China’s MicroPort Orthopedics invested $15 million as part of a partnership deal between the 2 companies. Through the partnership, Lombard will seek to accelerate commercialization of its Arofix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese market. As part of the deal, Microport and Lombard said they entered a component supply manufacturing deal, with Microport manufacturing comp...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Mergers & Acquisitions Stent Grafts Vascular Lombard Medical Technologies MicroPort Scientific Source Type: news

MassDevice.com +5 | The top 5 medtech stories for December 13, 2016
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. Defymed partners with Semma Therapeutics on bio-artificial pancreas French biotech developer Defymed said today it inked a collaborative deal with American biotech company Semma Therapeutics to support the continued development...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news