Cardiovascular
Syncardia Nabs Two Humanitarian Use Device Wins for Its Smaller Artificial Heart
March 18, 2013 2:12 pm | by Mass Device | News | CommentsSynCardia 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 | CommentsA 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.
InspireMD Wins CE Mark for MGuard Blood Clot Stent
March 15, 2013 1:56 pm | by Mass Device | News | CommentsInspireMD 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 | CommentsRising 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 | CommentsTEL-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 | CommentsMedical 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 | CommentsSunshine 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 | CommentsThis 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 | CommentsSAN 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 | CommentsCordis 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 | CommentsSAN 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 | CommentsST. 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 | CommentsSAN 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 | CommentsAbiomed (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.
Transcatheter Mitral Valves Are Going to the Dogs
March 11, 2013 4:23 pm | by Mass Device | News | CommentsThe field of transcatheter mitral valve repair may move more quickly in pet populations than it does in human medicine, according to a presentation during this week's American College of Cardiology conference in San Francisco. Researchers are hard at work on a technology, called MitralSeal, they they hope to bring to market to treat mitral valve regurgitation in dogs.
With Medtronic Resolute Stent, Interrupting Dual Antiplatelet Therapy After One Month Showed No Increased Safety Risk in Robust Analysis
March 11, 2013 12:18 pm | by The Associated Press | News | CommentsCardiologists at ACC.13 learned today that patients with coronary artery disease who received a Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) as participants in one of several clinical studies and interrupted or discontinued their dual antiplatelet therapy after one month of the implant procedure showed no increased safety risk through one year of follow-up.
AtriCure Appoints Robert S. White to its Board of Directors
March 11, 2013 9:00 am | by The Associated Press | News | CommentsWEST CHESTER, Ohio--(BUSINESS WIRE)--Mar 11, 2013--AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage, today announced that Robert...
Data Presented at ACC 2013 Confirms Use of Corus@ CAD in Women with Suspected Obstructive Coronary Artery Disease Influences Patient Management Decisions
March 11, 2013 8:31 am | by The Associated Press | News | CommentsCardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced results of a prospective study that evaluated how Corus@ CAD, a blood-based gene expression test, influenced cardiologists' patient management decisions in women with suspected obstructive coronary...
St. Jude Medical Announces Launch of 3D Vessel Reconstruction Technology in Japan
March 11, 2013 8:00 am | by The Associated Press | News | CommentsST. PAUL, Minn.--(BUSINESS WIRE)--Mar 11, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of its ILUMIEN ™ OPTIS ™ System, a next-generation technology designed to help physicians make personalized stenting decisions based on each patient’s...
Gore Launches Lower Profile GORE® EXCLUDER® AAA Endoprosthesis Contralateral Leg Components in US and Europe
March 11, 2013 4:00 am | by The Associated Press | News | CommentsFLAGSTAFF, Ariz.--(BUSINESS WIRE)--Mar 11, 2013--W. L. Gore & Associates, Inc. (Gore) has announced the US and European launch of lower profile contralateral leg components for the GORE® EXCLUDER® AAA Endoprosthesis used to treat abdominal aortic aneurysms (AAAs). The reduced profile sizes...
Early results "encouraging" for Edwards' redesigned Sapien XT valve
March 10, 2013 12:47 pm | by Mass Device | News | CommentsMedical device maker Edwards Lifesciences unveiled results from the 1st randomized study of its Sapien XT transcatheter aortic valve replacement system, reporting non-significant improvements in safety when compared with the original Sapien system. The PARTNER II trial's Cohort B was designed to demonstrate that the Sapien XT was at least non-inferior to Sapien classic...
New Data Reinforce Significant Blood Pressure Reduction Sustained to Two Years Using the Symplicity(TM) Renal Denervation System
March 10, 2013 12:18 pm | by The Associated Press | News | CommentsMedtronic, Inc. announced 24-month data from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation. Presented for the first time today at the 62nd Annual Scientific Session of the American College of Cardiology, the data show patients treated with the Symplicity renal denervation system (n=66) sustained a significant drop in blood pressure.
The Boston Scientific PROMUS Element™ Platinum Chromium Stent Demonstrates Continued Low Event Rates Through Three Years
March 10, 2013 11:30 am | by PR Newswire | News | CommentsNATICK, Mass., March 10, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reported clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Coronary...
Abbott's Minimally Invasive MitraClip® System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery
March 10, 2013 11:30 am | by PR Newswire | News | CommentsSAN FRANCISCO, March 10, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip® System for the treatment of mitral...
Boston Scientific Apologizes for Embargo Breach that Got Its Watchman Trial Pulled from Conference
March 9, 2013 11:16 pm | by Mass Device | News | CommentsAmerican College of Cardiology conference organizers cancel the highly anticipated presentation of preliminary results from Boston Scientific's PREVAIL study after the company leaks the data ahead of time. Boston Scientific publishes the slides that would have been presented.
