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Balloon-Forming Innovations Improve Quality and Reduce Cost

October 19, 2012 4:17 pm | by David Yanes and Eric Mabry | Interface Catheter Solutions | Articles | Comments

Catheter balloons are an important device for a variety of cardiovascular treatments. However, their manufacture can be a complicated process that, if completed wrong, can lead to waste and excess costs. This article highlights a number of innovative technologies that are being offered to help balloon manufacturers ensure their products are defect-free the first time.

Applying Tech: Cardiovascular, Part II

October 18, 2012 3:27 pm | by John Beigel, Brian McPherson, Robert Hergenrother, Peter Gabriele, and Donald M. Garcia | Meder Electronic Inc., SurModics, Inc., Secant Medical, Inc. , Boyd Coatings Research, Inc. | Articles | Comments

It’s not the journey, it’s the destination. In the case of interventional cardiovascular devices, both the journey and the destination are vital. These devices need to navigate the tortuous pathways of the vasculature in order to access and treat complex distal lesions. Getting there isn’t always easy.

Applying Tech: Cardiovascular, Part I

October 18, 2012 3:12 pm | by Andrew Cannon, Richard M. Rots, Mark Geiger, John Schmitz, and Sascha Weiler | Hoowaki, LLC, Interface Catheter Solutions | Articles | Comments

When a manufacturer picks up a cardiovascular device, they literally hold someone’s life. There is no room for flaws in the quality of this product, or any other in the cardiovascular realm. These devices are shrinking, while becoming increasingly advanced—more intricate parts achieve more complex functions, within a surface area that leaves only enough space for perfection. So the case has never been greater for quality assurance. Conducting risk analysis through variation analysis software can satisfy it.

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Medtronic Announces Approval and Launch of Japan’s First MR-Conditional Pacemaker System

October 18, 2012 12:32 pm | by Medtronic | News | Comments

Medtronic, Inc. (NYSE: MDT), today announced the Japanese regulatory approval and launch of the Advisa DR MRI™ SureScan™ pacing system. The Advisa MRI system is the first and only MR-Conditional pacemaker available to patients in Japan, the world’s second largest market for medical devices.

AngioDynamics to Acquire Vortex Medical

October 8, 2012 4:28 pm | by GLOBE NEWSWIRE | News | Comments

AngioDynamics, a leading provider of innovative minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today it has entered into a definitive agreement to acquire all the outstanding capital stock of Vortex Medical Inc., a privately-held company focused on the development of innovative medical devices...

Slovenia's First Total Artificial Heart Patient Receives Heart Transplant

October 8, 2012 3:04 pm | by SynCardia Systems | News | Comments

SynCardia Systems, Inc., manufacturer of  the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that University Medical Center (UMC) Ljubljana has transplanted Slovenia's first patient to receive the SynCardia temporary Total Artificial Heart. The patient, 61-year-old Nikola Gašpic, received a matching donor heart on July 1...

Cook Medical Launches Zilver Vena Venous Self-Expanding Stent in Canada

October 8, 2012 2:48 pm | by Cook Medical | News | Comments

Following Health Canada approval, Cook Medical made the Zilver Vena Venous Self-Expanding Stent available to physicians across Canada at the 2012 Annual Meeting of the Canadian Society for Vascular Surgery. Designed to restore blood flow in obstructed iliofemoral veins, Zilver Vena provides physicians with a tool designed specifically for stenting obstructed iliofemoral veins.

Mediware Receives Updated FDA Clearance for Core Blood Products

October 4, 2012 4:07 pm | by GLOBE NEWSWIRE | News | Comments

Mediware Information Systems, Inc. (Nasdaq:MEDW) announced that the 2012 versions of the company's core blood management software products, including LifeTrak(R) and HCLL(R) Transfusion, have received updated 510(k) clearance by the US FDA. The software systems are used by more than 500 hospital and blood center facilities in the United States, Canada, Ireland, and Singapore...

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Analyst Insight: Investors Breathe Sigh of Relief: Boston Scientific Gets First-in-Class FDA Go-Ahead

October 3, 2012 11:17 am | by GlobalData | News | Comments

On September 28, 2012, the US Food and Drug Administration granted the Boston Scientific Corporation (BSX) regulatory approval for its first-in-class subcutaneous implantable defibrillator (S-ICD) system. This S-ICD system establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy.

Tangent Medical Receives FDA Clearance for the NovaCath Secure IV Catheter System

September 28, 2012 9:05 am | by Tangent Medical | News | Comments

Ann Arbor-based Tangent Medical, an innovator in IV therapy products, recently announced it has received FDA 510(k) clearance for the NovaCath™ Secure IV Catheter System, a product designed to set new standards in peripheral IV catheter design, functionality and performance.

Analyst Insight: Abbott’s Absorb is the New Face of the Stent Industry

September 27, 2012 9:29 am | by GlobalData | News | Comments

The world’s first drug-eluting bioabsorbable vascular scaffold has been launched and will revolutionize the stent industry. On September 25th, 2012, Abbott announced the launch of its drug-eluting bioabsorbable stent, Absorb, in Europe, the Middle East and parts of Asia Pacific and Latin America. Absorb, which received CE mark certification in 2011, is used to treat coronary artery disease.

Merit Medical Receives 510(k) Clearance to Market the Merit Laureate Hydrophilic Guide Wire

September 24, 2012 9:44 am | by GLOBE NEWSWIRE | News | Comments

Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received 510(k) clearance from the Food and Drug Administration to market the Merit Laureate(R) hydrophilic guide wire.

UL and AAMI to Develop Interoperability Standards

September 18, 2012 3:14 pm | by Underwriters Laboratories | News | Comments

With the goal of improving patient safety and healthcare efficiency, AAMI and UL (Underwriters Laboratories) are joining forces to develop a suite of standards on medical device interoperability-one of the biggest challenges facing the modern healthcare community. The collaboration is a first for AAMI and UL, and comes at a time when many healthcare facilities and manufacturers are grappling...

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Maquet Study Results May Invalidate Industry Standard for Treating Cardiogenic Shock

August 30, 2012 3:46 pm | by GlobalData | News | Comments

Primary results from an ongoing trial conducted by Maquet Cardiovascular, a subsidiary of the Swedish Getinge Group, investigating the use of intra-aortic balloon pumps (IABP) as an adjuvant treatment for myocardial infarction (MI) complicated by cardiogenic shock have shown no difference in patient survival compared to standard care alone.

AngioDynamics Earns FDA Clearance for First Vascular Access Product With BioFlo Technology to Reduce Catheter-Related Thrombus

August 30, 2012 2:24 pm | by GLOBE NEWSWIRE | News | Comments

AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology...

TAVI restricted to very old or very sick patients

August 30, 2012 2:21 pm | by European Society of Cardiology | News | Comments

Cardiologists are restricting the use of transcatheter aortic valve implantation (TAVI) to very old or very sick patients at high surgical risk, according to research presented at the ESC Congress today. The first results of the Transcatheter Valve Treatment (TCVT) Sentinel Pilot Registry were presented by registry chairman Professor Carlo Di Mario.

Medtronic launches Resolute integrity coronary stent system in Japan

August 29, 2012 10:28 am | by Medtronic | News | Comments

Expanding global access to proven cardiovascular treatment options, Medtronic, Inc. (NYSE: MDT) announced today the launch of the Resolute Integrity™ Coronary Stent System in Japan, the world’s second largest market for medical devices. Indicated for the treatment of coronary artery disease, the Resolute Integrity drug-eluting stent offers a combination of superior deliverability...

ESC Acute Cardiovascular Care Association launched

August 29, 2012 10:17 am | by European Society of Cardiology | News | Comments

The Acute Cardiovascular Care Association (ACCA) of the European Society of Cardiology (ESC) was created today after a vote at the ESC Congress General Assembly. ACCA was previously the ESC Working Group on Acute Cardiac Care. Today it becomes one of six ESC Associations, whose presidents are invited to ESC Board meetings.

German aortic valve registry (GARY) aims to determine best valve disease treatment

August 29, 2012 10:10 am | by European Society of Cardiology | News | Comments

The German Aortic Valve Registry (GARY) was started in July 2010 and is the only registry so far to include both transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacements and repair. The intention is to deliver a complete picture of current and future practice of treating aortic valve disease and to deliver reliable data on the short and long-term outcome of different treatment strategies.

Women with acute heart failure have similar in-hospital mortality to men but are less treated

August 27, 2012 9:30 am | by European Society of Cardiology | News | Comments

Women with acute heart failure have similar in-hospital mortality to men but are less treated in the real world, according to results from the global ALARM-HF registry presented today at the ESC Congress 2012. The findings were presented by Dr John T. Parissis from Greece. Acute heart failure (AHF) is a frequent clinical situation with high short- and long-term mortality...

Drug eluting stents used less often in women than men

August 27, 2012 9:28 am | by European Society of Cardiology | News | Comments

Drug eluting stents (DES) are used less often in women treated with percutaneous coronary intervention (PCI) for coronary artery disease than men treated with PCI for the same condition, according to research presented today at the ESC Congress 2012. The findings from a country-wide Germany registry were presented by Dr Martin Russ.

Non-invasive fractional flow reserve in identification of flow-restricting arterial blockage patients suspected coronary artery disease

August 27, 2012 9:25 am | by European Society of Cardiology | News | Comments

The DeFACTO study - ESC press release - ESC Congress 2012 - Munich, Germany – 26 August 2012: Data presented today from the prospective Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO) study show that, when compared to standard coronary angiography (CT), the non-invasive assessment of fractional flow reserve by computed tomography...

Heart separation device improves 3 year outcomes in heart failure patients

August 27, 2012 9:22 am | by European Society of Cardiology | News | Comments

A novel non-invasive device which separates healthy and damaged heart muscle and restores ventricle function improves 3 year outcomes in patients with ischemic heart failure, according to research presented at the ESC Congress 2012. The findings were presented by Professor William T. Abraham at an ESC press conference on 25 August and by Dr Marco Costa at an ESC Congress scientific session on 27 August.

Continuous spinal cord stimulation improves heart function

August 27, 2012 9:21 am | by European Society of Cardiology | News | Comments

Spinal cord stimulation improves heart function and could become a novel treatment option for heart failure, according to research presented at the ESC Congress 2012 today by Professor Hung-Fat Tse from Hong Kong. Heart failure is a progressive weakening of the heart muscle. It is a chronic condition that occurs when the heart cannot pump blood to meet the body’s needs.

Future of Healthcare: Could robots replace surgeons?

August 24, 2012 9:12 am | by I-Micronews | News | Comments

Philips Healthcare has become the exclusive distributor of Corindus’ robotic-assisted CorPath 200 system, as on August 22, 2012, Philips announced its agreement with Corindus to distribute the interventional cardiology system in the US. Coronary artery disease (CAD) is the most common type of heart disease and is characterized by the buildup of plaque and narrowing of the coronary arteries. Over time, CAD weakens the heart muscle...

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