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Medtronic Announces CE Mark and European Launch of Attain Performa Portfolio of Quadripolar Leads

March 5, 2013 10:06 am | by The Associated Press | News | Comments

Medtronic announced it has received a CE Mark and will begin the European launch of the Attain Performa portfolio of quadripolar leads. Paired with Medtronic Viva/Brava Quad cardiac resynchronization therapy defibrillators, Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies...

CircuLite® Receives Conditional IDE Approval for SYNERGY® Circulatory Support System Feasibility Trial

March 5, 2013 9:00 am | by The Associated Press | News | Comments

CircuLite®, Inc. today announced that it has received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the SYNERGY® Circulatory Support System, a minimally-invasive device designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.

Peripheral Artery Disease: Mercator MedSystems Wins CE Mark for Catheter Systems

March 4, 2013 12:12 pm | by Mass Device | News | Comments

Mercator MedSystems touted European regulatory approvals for a pair of micro-infusion catheters for the treatment of peripheral artery disease. The San Leandro, Calif.-based medical device company received CE Mark approval in the European Union to market its Cricket and Bullfrog catheters, which are designed to inject therapeutic agents safely through blood vessel walls into deep tissues.

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Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference

March 4, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn., & SAN FRANCISCO--(BUSINESS WIRE)--Mar 4, 2013--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present data from its ORBIT II study of coronary artery disease at the 2013 American College of Cardiology (ACC) conference in San Francisco, Mar. 9–11, 2013. This marks the...

Medtronic Approved to Update Resolute Integrity Stent’s CE Mark Labeling on Dual Antiplatelet Therapy

March 4, 2013 10:27 am | by Medtronic | News | Comments

Of relevance to the clinical practice of interventional cardiology, Medtronic announced that it has received regulatory approval to update the CE mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy, the shortest minimum duration referenced on the label for any device of its kind.

Asian Portable Heart Monitor Demand Drives Expansion of Global Diagnostic Cardiology Device Market

March 4, 2013 10:08 am | by IMS Research | News | Comments

Pumped up by rising demand in Asia for portable heart monitors, the global market for diagnostic cardiology devices is set to expand by 12 percent from 2011 to 2016, according a new report from IMS Research, now part of IHS. Worldwide market revenue for diagnostic cardiology devices is projected to rise to $882 million in 2016, up from $786 million in 2011.

Capital BlueCross Announces Designation of IPG as their Implantable Device Benefit Management Partner

March 4, 2013 8:00 am | by The Associated Press | News | Comments

ATLANTA--(BUSINESS WIRE)--Mar 4, 2013--Capital BlueCross and IPG, the leading nationwide provider of implantable Device Benefit Management™ (DBM) solutions, are pleased to announce an exclusive agreement to provide a comprehensive DBM program to participating facilities in Capital BlueCross’...

FDA Warns Doc on CoreValve Heart Implant Trial Record-Keeping Issues

March 1, 2013 1:51 pm | by Mass Device | News | Comments

Hard on the heels of a regulatory win in Europe for one of its heart implants, Medtronic got some bad news from the FDA regarding another. Yesterday Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for its next-generation Engager transcatheter aortic valve implant.

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Consumer Information on: VASCADE Vascular Closure System (VCS) - P120016

March 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The VASCADE Vascular Closure System (VCS) is designed to close a puncture site in the major artery of the thigh (femoral artery). The system is comprised of a delivery device and a collagen patch. Over time, the collagen patch breaks down and is...

Study: Boston Scientific's Watchman Heart Implant Bests Warfarin

February 28, 2013 3:32 pm | by Mass Device | News | Comments

The Watchman heart implant made by Boston Scientific improved quality-of-life measures more than warfarin in atrial fibrillation patients after 1 year, according to a study in the Journal of the American College of Cardiology. The more than 700-patient Protect AF trial produced QOL scores that were ahead of warfarin for the study's primary efficacy endpoint.

TAVI: Medtronic Lands European Win for Next-Gen Engager Heart Valve

February 28, 2013 11:44 am | by Mass Device | News | Comments

Medical device giant Medtronic won European regulatory approval for its Engager transcatheter aortic valve implantation system, the company announced today. The CE Mark indication includes approval for transapical delivery of the valve in treatment of patients with aortic stenosis who are too sick to undergo traditional surgery.

CardioKinetix Closes $23M Tranche in $48M Series E Round

February 28, 2013 11:09 am | by Mass Device | News | Comments

CardioKinetix said it's raised $48 million in its Series E round with the closure of a 2nd tranche worth $23 million and plans to use the proceeds to further its Parachute ventricular partitioning device, which is in a pivotal trial. The Menlo Park, Calif.-based company touts the Parachute as the 1st device designed to partition healthy tissue from heart muscle damaged during a heart attack.

Survival from Sudden Cardiac Arrest More Than Doubles with ZOLL CPR Feedback Technology and Resuscitation Training

February 28, 2013 10:18 am | by The Associated Press | News | Comments

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that a publication released in the reported that survival from one of the leading causes of death in the United States, out-of-hospital cardiac arrest, more than doubled when emergency medical providers utilized ZOLL defibrillators as part of a focused effort...

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CardioKinetix Completes $48 Million in Series E Financing for Catheter-Based Heart Failure Therapy

February 28, 2013 7:00 am | by The Associated Press | News | Comments

MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 28, 2013--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced today that it has completed the $23 million second-tranche of its Series E financing, bringing the total financing round to $48...

Sorin Group Closes Further Investment in Enopace Biomedical

February 28, 2013 3:30 am | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 28, 2013--Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today its additional minority investment and an option-to-buy in Enopace Biomedical, an early-stage company...

Premier Healthcare Alliance Doles Out Four New Contracts

February 27, 2013 3:09 pm | by Mass Device | News | Comments

Group purchasing organization Premier Healthcare Alliance awarded 4 new contracts for regional anesthesia, surgical instruments, operating room lights and brooms and instrument containers to a bevy of medical device companies. All of the new deals became available to acute care and continuum care Premier members Feb. 1.

John Muir Health Pilots Early Warning System For Heart Attack Patients

February 27, 2013 12:58 pm | by The Associated Press | News | Comments

WALNUT CREEK, Calif.--(BUSINESS WIRE)--Feb 27, 2013--Reducing the time it takes heart attack patients to receive treatment significantly increases their chances of survival and minimizes long-term damage to the heart and brain. John Muir Health’s Clinical Research Center recently began a clinical...

CellAegis Devices Announces Clinical Program to Use the Company's Noninvasive autoRICT Device for Chronic Remote Ischemic Conditioning (CRIC) following Acute Myocardial Infarction (AMI)

February 27, 2013 7:31 am | by The Associated Press | News | Comments

CellAegis Devices, Inc., announced today that it has received an Investigational Testing Approval (ITA) from Health Canada that allows the initiation of clinical testing in Canada of the Company's autoRICT Device for Chronic Remote Ischemic Conditioning (CRIC).  In a Canadian Institutes of...

STENTYS to Present Final Results From 1,000 Heart Attack Patient Study at ACC.13

February 26, 2013 11:35 am | by The Associated Press | News | Comments

STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing ® Stent to treat acute myocardial infarction, announced today that results for the primary endpoint in the APPOSITION III study (MACE at one year on 1,000 STEMI patients) will be presented during ACC.13, the American College of Cardiology’s Scientific Session & Expo.

HD Medical, Inc. Hosts Launch Celebration for Newly Formed US Business Unit at ACC.13

February 26, 2013 11:28 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Feb 26, 2013--At the American College of Cardiology’s 62nd Annual Scientific Session & Expo, ACC.13, HD Medical, Inc. will hold “Heart & Sound” an ACC.13 Industry Event celebrating the formation of HD Medical in the US. Come rejoice with us and enjoy good...

Medtronic Gains First FDA Approval to Conduct Early Feasibility Medical Device Study

February 26, 2013 10:06 am | by The Associated Press | News | Comments

Medtronic, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever FDA approval of an investigational device exemption (IDE) following the new draft FDA guidance for early feasibility studies.

Study: 1 in 10 Recalled St. Jude Medical Riata Lead Coatings Fail Within Six Years

February 25, 2013 2:43 pm | by Mass Device | News | Comments

Danish researchers reported this week that their latest studies of St. Jude Medical's recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years. The study included 298 Danish patients, representing "virtually every living patient in Denmark who received Riata defibrillator leads," according to Heartwire.

Saint Luke's Mid America Heart Institute Clinical Trial To Investigate Effectiveness Of Cardiac Surgery Device

February 25, 2013 11:45 am | by PR Newswire | News | Comments

Clinical trial to determine if chest closure device leads to better bone healing following cardiac surgery KANSAS CITY, Mo., Feb. 25, 2013 /PRNewswire-USNewswire/ -- Patients undergoing open heart procedures such as coronary artery bypass or valve surgery may be...

CSI Presents Three-Year Orbit I Coronary Data at CRT 2013

February 25, 2013 11:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn. & WASHINGTON--(BUSINESS WIRE)--Feb 25, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT)...

FDA Approves Longer Lengths of Medtronic's Resolute Integrity Stent

February 25, 2013 9:06 am | by The Associated Press | News | Comments

Expanding the applicability of its marquee product for the interventional treatment of coronary artery disease in the United States, Medtronic, Inc. announced today that the FDA has approved the 34 mm and 38 mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm, and 4.0mm with an indication for patients with diabetes.

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