Follow-Up Essential After Endovascular AAA Repair Follow-Up Essential After Endovascular AAA Repair
Compared to an open approach, endovascular repair (EVAR) of abdominal aortic aneurysm (AAA) offers early survival benefit but shows inferior late survival, according to UK researchers.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - October 31, 2016 Category: Radiology Tags: Neurology & Neurosurgery News Source Type: news
Gore wins Medicare add-on status for Excluder stent graft
W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis.
Set to go into effect Oct. 1, the change will allow facilities that use the device, in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, to be eligible for a new tech add-on payment of up to $5,250 per case. The payment will come in addition to the applicable base payment for the Medicare Severity Diagnosis-related group.
“Prior to the IBE, there were limited options for maintaining blood flow to the inter...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Stent Grafts Vascular Reimbursement W.L. Gore & Associates Source Type: news
Consuming fewer calories reduces the risk of abdominal aortic aneurysm, study suggests
Mice placed on a low-calorie diet are less likely to develop abdominal aortic aneurysms, according to a new stud. The paper suggests new ways to prevent the often fatal condition from occurring in humans. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - September 26, 2016 Category: Science Source Type: news
Does Adding Epidural to General Anesthesia Improve Survival in AAA Repair? Does Adding Epidural to General Anesthesia Improve Survival in AAA Repair?
Combining epidural and general anesthesia for abdominal aortic aneurysm repair is associated with improved survival and lower risk of complications, according to a recent study. But the associations may not hold up in the real world, other researchers suggest.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 19, 2016 Category: Surgery Tags: Emergency Medicine News Source Type: news
Essential Medical closes $14.9M Series B for vascular closure device
Essential Medical said today that it closed a $14.9 million Series B round to support the development and commercialization of its vascular closure devices.
The round was led by Amzak Health and joined by prior backer Royal DSM venture investment arm DSM Venturing, the Malvern, Pa.-based company said.
“We are thrilled that Amzak Health has the confidence in the novel Essential Medical technology and our team to lead this round of financing along with our original investors. The Amzak group will also provide additional expertise and experience to our board of directors as our company transitions to commercialization ...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Vascular Essential Medical Devices Source Type: news
Endologix touts 1st Ovation Alto stent graft implantations
Endologix (NSDQ:ELGX) last week announced that its Ovation Alto abdominal stent graft system has been used in its 1st 2 procedures to treat abdominal aortic anneurysms.
The procedures were performed at New Zealand’s Auckland City Hospital by Dr. Andrew Holden and Dr. Andrew Hill, the Irvine, Calif.-based company said.
“The 1st patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a wide range of a...
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Surgical Vascular Endologix Inc. Source Type: news
Drinking green tea to prevent artery explosion: Polyphenol intake reduces abdominal aneurysm expansion in rats
Green tea could prevent a deadly condition in the body ' s main artery. A team has found that abdominal aortic aneurysm -- a condition in which the main artery becomes overstretched and bloated -- developed less frequently in rats that drank green tea polyphenol, a major component of green tea. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 23, 2016 Category: Science Source Type: news
Lombard Medical exits U.S. market, shares jump
Lombard Medical Technologies (NSDQ:EVAR) said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft.
Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn.
Irvine, Calif.-based Lombard said it plans to focus exclusively on the European Union, Japan and other “key” international markets. The company in June won CE Mark approval in the European Union for the IntelliFlex device....
Source: Mass Device - August 23, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic MassDevice Earnings Roundup Stent Grafts Wall Street Beat Lombard Medical Technologies Source Type: news
Quality assurance report: observations and recommendations from the visit to Central England on 2 February 2016
Public Health England (PHE) - This document presents the executive summary of the quality assurance report to the NHS abdominal aortic aneurysm screening programme in Central England.Summary reportPHE publications (Source: The Kings Fund - Health Management Specialist Collection)
Source: The Kings Fund - Health Management Specialist Collection - August 16, 2016 Category: Health Management Authors: The King ' s Fund Information & Knowledge Service Tags: Quality of care and clinical outcomes Regulation, governance and accountability Source Type: news
InSeal Medical wins CE Mark for vascular closure device
InSeal Medical said today it won CE Mark approval in the European Union for its InClosure vascular closure device designed to close large bore arterial punctures.
The device is implanted percutaneously and requires no pre-procedure or sheath exchange and features a biodegradable membrane which is coupled to the vessel wall by a thin Nitinol frame, the Israel-based company said.
“The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR. Based on our growing experience, the InClosure VCD allows for a smoother and safer TAVR procedure without pre-pro...
Source: Mass Device - August 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance InSeal Medical Ltd. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 5, 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.
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5. Check-Cap partners with GE to dev indigestible X-ray screening capsule
Check-Cap said yesterday it inked a development and manufacturing validation deal with GE Healthcare for integrating X-ray source production and assembly in...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Endologix releases Q2, updates on Nellix discussions with FDA
Endologix (NSDQ:ELGX) on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is requesting additional information and may need an Advisory Committee Panel before it can obtain approval.
The company said that without a required panel, it is hopeful it will receive premarket approval from the FDA for the device in the 1st quarter of 2017. With a required panel, the company expects approval some time in the 3rd quarter of 2017.
“In July, we completed our 100-day PMA meeting with the FDA and remain confident...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Vascular Endologix Inc. Source Type: news
Duke again among top ranked U.S. hospitals
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Duke University Hospital in Durham, NC is once again ranked among the nation ’s best hospitals in U.S. News& World Report ’s 2016-2017 Best Hospitals Honor Roll.
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Debbe Geiger
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Duke University Hospital in Durham, NC is once again ranked among the nation ’s best hospitals in<a href="http://health.usnews.com/best-hos...
Source: dukehealth.org: Duke Health News - August 2, 2016 Category: Consumer Health News Authors: dg62 at duke.edu Source Type: news
Gore wins FDA nod for Tigris vascular stent
W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating peripheral artery disease.
The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, the Newark, Del.-based company said.
“At Gore, we pride ourselves in continuous evaluation of how our technologies can benefit patients. To design an uncovered stent that navigates and conforms to the complex anatomy of the artery, we leveraged our long history with endovascular devic...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Vascular W.L. Gore & Associates Source Type: news
UCLA Health hospitals rank No. 1 in California and Los Angeles, No. 5 in U.S.
UCLA Health hospitals in Westwood and Santa Monica were ranked No. 1 in both Los Angeles and California and No. 5 in the nation in U.S. News and World Report’s annual honor roll.
The state and local rankings evaluate hospitals’ quality in nine relatively common procedures and treatments: abdominal aortic aneurysm repair, aortic valve surgery, chronic obstructive pulmonary disease, colon cancer surgery, care for congestive heart failure, heart bypass surgery, hip replacement, knee replacement and lung cancer surgery.
“By any measure, UCLA Health delivers the highest quality care available,” said Johnese Spisso, pres...
Source: UCLA Newsroom: Health Sciences - August 2, 2016 Category: Universities & Medical Training Source Type: news
