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Consumer Information on: Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) - P110013S005

March 22, 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 to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.  

Analyst: FDA OK Unlikely for Abbott Heart Device

March 21, 2013 1:09 pm | by The Associated Press | News | Comments

A medical device industry analyst says Abbott Laboratories is unlikely to win approval anytime soon for its device used to repair heart valve problems, following a tepid endorsement by government experts. A Food and Drug Administration panel of heart experts voted 5-3 on Wednesday that the...

Intermountain Medical Center Uses SynCardia Total Artificial Heart to Bridge 31-Year-Old Father to a Heart Transplant

March 21, 2013 11:24 am | by SynCardia Systems | News | Comments

SynCardia Systems announced today that Andrew Weaver, a 31-year-old husband and father of one who arrived at Intermountain Medical Center in Salt Lake City in grave condition, has been successfully bridged to a heart transplant with the SynCardia temporary Total Artificial Heart and discharged home.

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FDA Advisory Committee Votes Favorably on Abbott's Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who Are Too High Risk for Surgery

March 20, 2013 7:44 pm | by PR Newswire | News | Comments

ABBOTT PARK, Ill., March 20, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of...

FDA Panel Votes 5-3 that Benefits of Abbott's MitraClip Heart Implant Outweigh the Risks

March 20, 2013 6:55 pm | by Mass Device | News | Comments

The FDA's Circulatory System Devices Panel voted today to make its recommendation regarding Abbott's (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.

Results of St. Jude Medical's RESPECT Trial Published in The New England Journal of Medicine

March 20, 2013 5:08 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 20, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced publication of results from its landmark RESPECT trial in The New England Journal of Medicine. The study results show that device closure using the AMPLATZER™ PFO...

Sorin Group Receives Conditional FDA Approval to Conduct RESPOND CRT Clinical Trial Using Innovative Heart Failure Management Technology

March 20, 2013 10:00 am | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Mar 20, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device...

Newly Published Data Indicates St. Jude Medical Trifecta Heart Valve Closely Resembles the Hemodynamic Performance of a Natural, Healthy Heart Valve

March 19, 2013 4:15 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 19, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that its Trifecta ™ biological pericardial aortic valve has demonstrated positive results in a new study published online in The Journal of Thoracic and Cardiovascular...

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DC Devices lands $10.7M equity funding in support of transcatheter cardiac shunt

March 19, 2013 2:50 pm | by Mass Device | News | Comments

Massachusetts-based medical device startup DC Devices closed a $10.7 million funding round in support of its minimally invasive treatment for heart failure. DC Devices "seeks to become the leading medical device company for the treatment of congestive heart failure," according to its page on the website of venture capital firm General Catalyst.

Douglas Harrington, MD Addresses Select Group of Physicians Regarding Latest Advances in Cardiovascular Risk Assessment

March 19, 2013 2:44 pm | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 19, 2013--Aviir Inc., a biotechnology company dedicated to enhanced detection and prevention of cardiovascular disease through innovative diagnostic tests, announced that Douglas Harrington, MD, Clinical Professor of Pathology at USC and Aviir, Inc. CEO,...

Topera Medical Raises $25 Million

March 18, 2013 3:08 pm | by Mass Device | News | Comments

Medical device start-up Topera Medical closed a $25 million funding round, according to federal Securities & Exchange Commission filings. The San Diego, Calif.-based startup, which came out of stealth mode at the Heart Rhythm Society meeting last year, has FDA 510(k) clearance for its RhythmView 3D mapping system.

Syncardia Nabs Two Humanitarian Use Device Wins for Its Smaller Artificial Heart

March 18, 2013 2:12 pm | by Mass Device | News | Comments

SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device. The new HUD designations apply to use with children, smaller women and other people with small stature.

Looking Back on a Pretty Sedate ACC

March 18, 2013 9:29 am | by Mass Device | News | Comments

A review of the actionable news that came out of last week's American College of Cardiology conference in San Francisco, including mixed feelings about Boston Scientific's Watchman stroke prevention device and incremental findings for renal denervation.

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InspireMD Wins CE Mark for MGuard Blood Clot Stent

March 15, 2013 1:56 pm | by Mass Device | News | Comments

InspireMD said it won a nod from European regulators for its MGuard embolic protection stent, designed to prevent strokes after carotid artery stenting procedures. The company said the MGuard device is wrapped with its MicroNet mesh to prevent embolisms – blood clots – from occurring during and after the placement of a carotid stent.

The Medtronic Foundation Launches Its "Save a Life" Campaign with the Timberwolves' Ricky Rubio

March 15, 2013 1:26 pm | by Mass Device | News | Comments

Rising Timberwolves basketball star Ricky Rubio is the face of the Medtronic (NYSE:MDT) Foundation's new televised public service announcement, " The Heart Rescue Project." This new campaign for sudden cardiac arrest (SCA), the leading cause of death among young athletes, debuted online last month.

InspireMD Receives CE Mark Approval for Carotid Embolic Protection Stent

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

TEL-AVIV, Israel, March 15, 2013 /PRNewswire/ -- InspireMD's Carotid Embolic Protection Stent, based on InspireMD's proprietary MicroNet[TM] mesh technology, is designed to provide procedural and post-procedural distal embolic protection in...

Medtronic Seeks to Claw Back $10M Patent Lawsuit Loss

March 13, 2013 4:47 pm | by Mass Device | News | Comments

Medical device giant Medtronic (NYSE:MDT) is looking for avenues to reverse a $10 million patent infringement loss over angiography catheters. In January 2012 an Oklahoma jury ordered Medtronic to pay $9.9 million in back royalties for willfully infringing on a guidance catheter patent

Sunshine Heart Appoints Jon Salveson to Board of Directors

March 13, 2013 4:36 pm | by The Associated Press | News | Comments

Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) today announced that Jon W. Salveson has been appointed to the Company's Board of Directors. Mr. Salveson is the Vice Chairman, Investment Banking and Chairman of the Healthcare Investment Banking Group at Piper Jaffray Companies...

Consumer Information on: Aorfix Flexible Stent Graft System - P110032

March 13, 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 to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Direct Flow Medical Transcatheter Aortic Valve System Demonstrates Excellent Six-Month Outcomes in DISCOVER Trial

March 12, 2013 3:47 pm | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 12, 2013--Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, announced that the DISCOVER Trial results presented Sunday at the American College of Cardiology (ACC) Annual Meeting showed that patients treated...

J&J's Cordis Snaps Up Flexible Stenting Solutions

March 12, 2013 2:41 pm | by Mass Device | News | Comments

Cordis Corp., the stent-making arm of healthcare colossus Johnson & Johnson, said it's acquired Flexible Stenting Solutions as part of turning its back on the coronary stents market in favor of the endovascular arena. Bridgewater, N.J.-based Cordis didn't reveal the purchase price or any details for its buyout of FSS, which makes the FlexStent self-expanding stent.

Study Finds Intraosseous Vascular Access Devices Are Safe, Effective and Cost Less than Central Venous Catheters in Hospital Setting

March 12, 2013 10:57 am | by The Associated Press | News | Comments

SAN ANTONIO--(BUSINESS WIRE)--Mar 12, 2013--The results of an observational study comparing the use of intraosseous (IO) vascular access devices to central venous catheters found that IO can be used with equal safety and efficacy, and at a significantly lower cost, for patients in a hospital...

Cardiovascular Systems’ Orbital Atherectomy Technology Highlighted at ACC Innovations Forum

March 12, 2013 10:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn., & SAN FRANCISCO--(BUSINESS WIRE)--Mar 12, 2013--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), was featured as part of the “Innovation and Technology Adoption” presentation during the Innovations Educational Forum at the 2013 American College of Cardiology (ACC) conference...

Screening for BNP & Targeted Care Reduce Heart Failure in At-Risk Patients

March 11, 2013 5:52 pm | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 11, 2013--Alere Inc. (NYSE: ALR) is pleased to announce the results of research presented at today’s American College of Cardiology’s 62nd Annual Scientific Session, which showed that a simple screening and management program can be effective in preventing heart...

Abiomed Lands Reimbursement Expansion for Impella Heart Pump

March 11, 2013 5:00 pm | by Mass Device | News | Comments

Abiomed (NSDQ:ABMD) won expanded reimbursement for its flagship Impella heart pump from 4 private and Medicare Advantage insurers, including 1 of the largest names in the industry. Humana, UnitedHealthcare Medicare Risk, Independence Blue Cross and Capital Blue Cross. The expanded coverage at the private or Medicare Advantage plans includes new Impella policies.

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