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NxStage debuts 3 new home-dialysis products

November 22, 2013 2:39 pm | by Mass Device | News | Comments

NxStage Medical debuted 3 new products this week during the American Society of Nephrology's Annual Kidney Week 2013. The Lawrence, Mass-based medical device company trotted out its System One S, the next generation of NxStage's System...

CMS proposes cardiac rehab for patients with chronic heart disease

November 22, 2013 1:13 pm | by Mass Device | News | Comments

Medicare regulators issued a new Proposed Decision Memo, offering expanded coverage for cardiac rehabilitation services for certain patients with heart failure. The federal agency opened up its traditional public commenting period, soliciting...

Sorin wins CE Mark for stentless heart valve

November 22, 2013 8:56 am | by Mass Device | News | Comments

Sorin Group said it won CE Mark approval in the European Union for its Solo Smart heart valve, designed to replace the aortic valve without leaving a stent in place. Milan-based Sorin said the Solo Smart device is the next iteration of its Freedom...

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The Modern Algorithm For Management Of Massive And Submassive Pulmonary Embolism

November 21, 2013 10:30 am | by PR Newswire | News | Comments

Acute pulmonary embolism (PE) is a potentially life-threatening condition, reporting an overall mortality rate of 15% in the first three months after diagnosis. The literature describes a three-tier risk stratification scale (massive, submassive...

Early Data Show Potential for Investigational Bioengineered Vessel as Dialysis Graft

November 21, 2013 10:19 am | by Duke University Medical Center | News | Comments

An investigational, man-made blood vessel used in vascular grafts for kidney dialysis patients may potentially show encouraging early results among study patients in Poland, according to preliminary data reported Wednesday by a researcher at...

Researchers Engineer First-Ever Living 3D Human Arrhythmic Tissue

November 21, 2013 10:11 am | by Erin Vollick, University of Toronto | News | Comments

A foundational study published in top biomedical journal PNAS (Proceedings of the National Academy of Science) this week by researchers at the University of Toronto’s Institute of Biomaterials & Biomedical Engineering (IBBME) and the McEwen...

Smart Glasses Solution to Detect Patient Veins for Precise IV Placement

November 20, 2013 9:49 am | by Evena Medical | News | Comments

Evena Medical, a leader in the development of high-quality, high-definition imaging for fast, accurate and precise venous access, today announced the launch of its Eyes-On™ Glasses System, a one-of-a-kind point-of-care wearable unit which...

Boston Scientific Receives FDA Clearance And CE Mark Approval For Direxion Torqueable Microcatheter

November 19, 2013 6:02 pm | by PR Newswire | News | Comments

Further bolstering its market-leading portfolio of peripheral embolization technologies, Boston Scientific Corporation has received U.S. Food and Drug Administration clearance and CE Mark approval for its Direxion Torqueable Microcatheter...

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Cardiovascular Systems' public offering could garner $70M

November 19, 2013 3:36 pm | by Mass Device | News | Comments

Cardiovascular Systems announced this week an upcoming stock offering worth up to $70 million in net proceeds, according to an early estimate. The device maker has yet to issue share pricing or the date of the sale, but said in prospectus...

Gore Launches Early Cannulation Capable GORE® ACUSEAL Vascular Graft

November 19, 2013 2:25 pm | by Business Wire | News | Comments

W. L. Gore & Associates (Gore) today announced the launch of the GORE ACUSEAL Vascular Graft for vascular access. Designed for early cannulation within 24 hours after implantation, the GORE ACUSEAL Vascular Graft expands treatment options...

Breakthrough in Adult Heart Repair

November 19, 2013 12:04 pm | by The Company of Biologists | News | Comments

Researchers from the Baylor College of Medicine and the Texas Heart Institute have discovered a new way to dramatically improve heart repair. The future goal is to use this knowledge to combat human cardiovascular disease by improving repair...

Appeals court affirms $10M Medtronic loss in catheter patent case

November 19, 2013 11:00 am | by Mass Device | News | Comments

A federal appeals court dealt a blow to Medtronic yesterday when it upheld a lower court's decision to award $10 million to the physician inventor of a patent involving catheters. The U.S. Court of Appeals for the Federal Circuit affirmed an...

Stents May Not Help Treat Clogged Kidney Arteries

November 19, 2013 10:01 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

New research raises serious questions about a very common medical procedure — placing a stent to prop open a narrowed kidney artery. A study found that people treated with these stents plus various heart drugs fared no better than people treated...

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Unexpectedly strong ICD sales for Medtronic buoy Boston Scientific

November 19, 2013 9:59 am | by Mass Device | News | Comments

Medtronic posted stronger-than-expected U.S. sales growth for its implantable cardioverter defibrillators, buoying shares of ICD rival Boston Scientific. Medtronic's U.S. ICD sales grew 3.9% during its fiscal 2014 2nd quarter ended Oct. 25, rising...

AtriCure Receives FDA Approval for Investigational Study to Evaluate Stroke Prevention in Atrial Fibrillation

November 19, 2013 8:00 am | by Business Wire | News | Comments

AtriCure, a leading developer of solutions to treat atrial fibrillation, today announced the Food and Drug Administration’s approval to begin enrollment in a clinical study of AtriCure’s AtriClip Left Atrial Appendage Exclusion System. The study will...

Vascular Solutions signs 'cooperation agreement' to get ITGI's stent on the U.S. market

November 18, 2013 1:29 pm | by Mass Device | News | Comments

Stent makers Vascular Solutions (NSDQ:VASC) and ITGI Medical Ltd. (TASE:ITGI) joined forces this week in pursuit of regulatory and commercial progress for ITGI's Aneugraft Dx coronary covered stent. Under the terms of the agreement Vascular...

Trial Shows Significant Delay in Atrial Fibrillation Disease Progression with Medtronic-Exclusive Pacing Features

November 18, 2013 12:09 pm | by Medtronic | News | Comments

New research shows that Medtronic Inc. pacemakers with enhanced pacing features have the ability to slow the progression of atrial fibrillation (AF) in patients with bradycardia, or a slow heartbeat. Presented as a late breaking clinical trial...

GE Healthcare Receives Approval for Its Own Manufacturing of Optison

November 18, 2013 9:00 am | by Business Wire | News | Comments

GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to allow the company to manufacture Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) in-house. Optison is...

Paragonix Technologies Inc., Announces Filing of a Second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

November 18, 2013 6:00 am | by Business Wire | News | Comments

Paragonix Technologies, Inc. today announced that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport...

FDA Issues Stern Warning on Medtronic Devices

November 16, 2013 7:19 pm | by David Koenig - AP Business Writer | News | Comments

Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery...

Heart Treatment Device, Cancer Test Take Top Prizes in Inventors Contest

November 15, 2013 11:55 am | by Johns Hopkins University | News | Comments

A Johns Hopkins undergraduate biomedical engineering student team that devised a two-part system to improve the way life-saving shocks are delivered to hearts earned first-prize in the undergraduate division of a national Collegiate Inventors...

The PrestoPatch Delivers Safer Shocks to the Heart

November 15, 2013 11:54 am | by PrestoPatch | Videos | Comments

In the United States alone, cardiac arrhythmias, or irregular heartbeats, afflict over 14 million people each year causing over 450,000 deaths. The standard of care for arrhythmias is to deliver electrical shocks to the heart via patch electrodes...

First Commercial Implants of Boston Scientific’s Lotus Valve System in Europe

November 15, 2013 11:26 am | by PR Newswire | News | Comments

Marking a major step forward in the evolution of Transcatheter Aortic Valve Implantation technology, the first two commercial implants of the Boston Scientific Lotus Valve System have taken place in a German hospital. Prof. Dr. med. Gerhard Schuler...

Consumer Information on: MitraClip Clip Delivery System

November 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

  This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications...  

Researchers Organize Programmed Nanoparticles into Highly Complex Nanostructures

November 14, 2013 3:17 pm | by Gutenberg Research College at Mainz University | News | Comments

Animal and plant cells are prominent examples of how nature constructs ever-larger units in a targeted, preprogrammed manner using molecules as building blocks. In nanotechnology, scientists mimic this ‘bottom-up’ technique by using the ability...

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