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Hypertension: ReCor Launches Post-Market Study of Next-Gen Paradise System

February 15, 2013 12:26 pm | by Mass Device | News | Comments

California medical device startup ReCor Medical launched a post-market study of its next-generation Paradise renal denervation system in treatment of patients with resistant high blood pressure. The 50-patient study has already enrolled patients at a participating facility in the Netherlands with the Paradise device.

St. Jude Looks Beyond Blood Pressure for Benefits of Renal Denervation

February 15, 2013 12:06 pm | by Mass Device | News | Comments

St. Jude Medical is aiming to take its renal denervation therapy a step further, looking for signs that the minimally invasive treatment improves health beyond lowering high blood pressure in patients with uncontrolled hypertension. The company's new Enlightnment trial is looking for long-term effects of renal denervation therapy...

St. Jude Medical Initiates Landmark Study of Renal Denervation for Reduction of Heart Attack, Stroke and Death

February 15, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 15, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood...

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BIOTRONIK Ilesto 7 ICD/CRT-D Series With ProMRI(R) Technology Gains CE Approval

February 15, 2013 4:00 am | by The Associated Press | News | Comments

BIOTRONIK, the leading manufacturer of cardiovascular medical technology that is celebrating its 50th anniversary in 2013, announced today that the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE...

Meeting Announcement: March 20, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

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

On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device.

Bard to Present at Citi 2013 Global Healthcare Conference

February 14, 2013 4:21 pm | by The Associated Press | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--Feb 14, 2013--C. R. Bard, Inc. (NYSE: BCR) today announced that it will present at the Citi 2013 Global Healthcare Conference in New York City on February 27, 2013. Timothy M. Ring, chairman and chief executive officer, will discuss the Company in a presentation...

Tigre Becomes First Heart Safe City in Argentina by Implementing ZOLL AED Plus

February 13, 2013 2:59 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 13, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the city of Tigre in the Province of Buenos Aires, has installed ZOLL AED Plus ® units in public areas throughout this popular tourist...

Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System

February 13, 2013 9:06 am | by The Associated Press | News | Comments

Second-generation MR-Conditional Pacemaker Combines Advanced Pacing Technology with MRI Access MINNEAPOLIS - February 13, 2013 - Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT), today announced the...

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Sherrie Glasser-Mayrsohn: Physical Therapy Performed in Intensive Care Units Improves Patient Outcomes

February 12, 2013 6:24 am | by Bio-Medicine.Org | News | Comments

NEW YORK , Feb. 12, 2013 /PRNewswire-iReach/ -- Science Daily has recently released an article that explains the value of physical therapy when performed in the intensive care unit (ICU). While the use of physical therapy at such an early stage in a patient's recovery has not always been accepted, the article asserts that researchers from Johns Hopkins have revealed that the ability to reduce...

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

February 12, 2013 6:00 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 12, 2013--Paragonix Technologies, Inc. today announced that it has received clearance for its Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System 1 (CTS). The...

Class I Medical Device Recall: St. Jude Medical, AMPLATZER TorqVue FX Delivery System

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

On January 17, 2013, St. Jude Medical sent an “Urgent Medical Device Recall Notice” to their customers. The letter advised customers to stop using the device and remove it from their inventory. St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.

Michael Berman Joins InspireMD Board

February 11, 2013 8:01 am | by The Associated Press | News | Comments

InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPRD) announced that Michael Berman joined its board of directors. Mr. Berman previously served as a Senior Vice President of Boston Scientific Corp., Group President of its cardiology businesses, and a member of the Executive Committee. ...

Zoll Lands FDA Clearance for Automated External Defibrillator

February 8, 2013 3:27 pm | by Mass Device | News | Comments

Zoll Medical wins 510(k) clearance for its AED Plus CPR-assist technology. Asahi Kasei (TYO:3407) subsidiary Zoll Medical won 510(k) clearance from the FDA for its fully-automated AED Plus device, which improves on the former semi-automatic model. The new automated external defibrillator allows emergency responders to pre-program a shock instead of pushing the "shock" button.

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Supreme Court Denies Retractable Technologies in Patent War with BD

February 8, 2013 3:08 pm | by Mass Device | News | Comments

The Supremes last month refused to hear an appeal of a lower court's decision to overturn part of Retractable's win over BD, which the Little Elm, Texas-based medical device company sued in June 2007, claiming that Becton's Integra syringes infringe patents covering its competing VanishPoint devices.

Data from St. Jude Medical RESPECT Trial for PFO Closure Highlighted at International Stroke Conference 2013

February 8, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu. The RESPECT...

Two-Year Clinical Study Supports Safety and Efficacy of Covidien Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Two-Year Clinical Study Supports Safety and Efficacy of Covidien Solitaire™ FR Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Researchers Find a Genetic Marker for Aortic Valve Disease

February 7, 2013 2:13 pm | by Mass Device | News | Comments

A research consortium tracks down a genetic variant that doubles the risk of buildup in the aortic valve that can cause heart failure, stroke and sudden cardiac death. A team of researchers have pinpointed a gene that may be responsible for double a patient's risk of calcium buildup in the aortic valve, a condition linked with heart failure, stroke and sudden cardiac death. The finding may lead to new research and therapies, which are very limited for patients with narrowing, or stenosis, of the aortic valve.

Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration

February 7, 2013 1:22 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin U.S. distribution of the new fully...

Sorin Group Announces Preliminary Results for 2012

February 7, 2013 12:06 pm | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 7, 2013--At a meeting held today and chaired by Rosario Bifulco, the Sorin S.p.A. (MIL:SRN) Board of Directors analyzed the results for the fourth quarter 2012 and the preliminary unaudited consolidated results for the year of 2012. The final draft of the financial...

Biosensors Collaborates with Terumo to Promote NoboriT in Japan

February 7, 2013 10:05 am | by The Associated Press | News | Comments

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, has announced a collaboration with Terumo Corporation to promote the NoboriT drug-eluting stent (DES) system at specific specialist cardiology centers in Japan.

Cardiva Medical, Inc. Announces FDA Approval for VASCADE Vascular Closure System

February 7, 2013 9:40 am | by PRNewswire | News | Comments

Cardiva Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression...

Abiomed CEO Shrugs off Impact of DoJ Probe, FDA Call

February 6, 2013 4:41 pm | by Mass Device | News | Comments

A U.S. Justice Dept. investigation and the FDA's decision to require pre-market approval for Abiomed's Impella heart pump leave CEO Michael Minogue unfazed. Cardiologists aren't paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.

European patient registry in venous thromboembolism (VTE) enrols first patient

February 6, 2013 11:29 am | by PR Newswire | News | Comments

MUNICH, February 6, 2013 /PRNewswire/ -- The registry plans to gather data from more than 4,000 patients with VTE across seven European countries, providing insights into the clinical management of a disease that is a leading cause of morbidity and mortality[1] Daiichi Sankyo...

Merit Medical Partners With Verite Mobile Tools and Strategies to Create an Innovative Medical Device Conversion App

February 6, 2013 9:00 am | by The Associated Press | Merit Medical Systems, Inc. | News | Comments

Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, and Vérité, a digital communications agency, announced the release of a cutting-edge iPhone App, Merit Convert, available on...

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