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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.

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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...

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.

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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.

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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.

FDA Approves First Single-Lead ICD with Atrial Sensing

February 25, 2013 9:00 am | by The Associated Press | News | Comments

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--Feb 25, 2013--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the Food and Drug Administration (FDA) has granted final approval for the BIOTRONIK Lumax 740 DX System. This novel device is a first-in-class implantable cardiac...

LabCorp Launches Next Generation Sequencing Assay for Familial Cardiac Disease

February 25, 2013 8:45 am | by The Associated Press | News | Comments

BURLINGTON, N.C.--(BUSINESS WIRE)--Feb 25, 2013--Laboratory Corporation of America ® Holdings (LabCorp ® ) (NYSE: LH) today announced it has launched its clinical next generation sequencing assay, GeneSeq®: Cardio for genetic causes of familial cardiac disease. Familial cardiac diseases are...

CardioDx to Present at Cowen and Company 33rd Annual Healthcare Conference

February 25, 2013 8:30 am | by The Associated Press | News | Comments

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company will present at the Cowen and Company 33rd Annual Healthcare Conference on Monday, March 4, 2013 at 10:00 a.m. ET at the Boston Marriott Copley Place in Boston.

Biotronik Lands Euro Approval for MRI-Friendly Heart Implants

February 22, 2013 9:29 am | by Mass Device | News | Comments

German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants. The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world's smallest implantable cardioverter-defibrillators, according to Biotronik.

NMMC Physicians Implant State's First Vagal Nerve Stimulator for Heart Failure

February 21, 2013 3:39 pm | by The Associated Press | News | Comments

Doctors at North Mississippi Medical Center recently implanted the state's first vagal nerve stimulator as part of a clinical research study to treat heart failure through nerve stimulation in the neck. According to cardiac electrophysiologist Karl Crossen, M.D., and neurosurgeon Louis...

OrbusNeich Rides Patent Win Over Boston Scientific to Germany, Netherlands

February 21, 2013 12:24 pm | by Mass Device | News | Comments

OrbusNeich is taking a recent patent infringement win against Boston Scientific even further, filing lawsuits in both Germany and the Netherlands to allege patent infringement over stent technology. OrbusNeich claims Boston Scientific's Promus Element, Promus Element Plus, Taxus, and other stents are infringing on a pair of patents.

Covidien Closes Enrollment in Iliac Stent Studies

February 21, 2013 11:38 am | by Mass Device | News | Comments

Covidien said it closed enrollment in a pair of its Visibility and Durability iliac stent clinical studies. The prospective, multinational studies are designed to compare balloon stents with self-expanding stents in the iliac arteries for treating peripheral artery disease.

SynCardia Total Artificial Heart Patient with End-Stage Renal Failure Recovers Kidney Function after Two Months of Support

February 21, 2013 5:51 am | by Bio-Medicine.Org | News | Comments

TUCSON, Ariz. , Feb. 21, 2013 /- At only 20 years old, Tiernee Gonzalez has been battling two major diseases for most of her young life: heart failure and kidney failure. When she became the first patient at Cincinnati Children's Hospital Medical Center to receive the SynCardia temporary Total Artificial Heart on Nov. 9, her doctors hoped it would bring her one step closer...

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