Cardiovascular
Michael Berman Joins InspireMD Board
February 11, 2013 8:01 am | by The Associated Press | News | CommentsInspireMD, 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 | CommentsZoll 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.
Supreme Court Denies Retractable Technologies in Patent War with BD
February 8, 2013 3:08 pm | by Mass Device | News | CommentsThe 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 | CommentsST. 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 | CommentsMANSFIELD, 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 | CommentsMANSFIELD, 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 | CommentsA 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 | CommentsCHELMSFORD, 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 | CommentsMILAN--(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 | CommentsBiosensors 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 | CommentsCardiva 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 | CommentsA 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 | CommentsMUNICH, 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 | CommentsMerit 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...
TherOx Begins IDE Study of Next-Generation Supersaturated Oxygen Therapy for AMI
February 6, 2013 8:00 am | by The Associated Press | News | CommentsIRVINE, Calif.--(BUSINESS WIRE)--Feb 6, 2013--TherOx, Inc., a privately held medical device company focused on the treatment of Acute Myocardial Infarction (AMI), today announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system that...
Vasomedical, Inc. to Present Live Webcast at RetailInvestorConferences.com on February 7th
February 6, 2013 8:00 am | by PR Newswire | News | CommentsNEW YORK, Feb. 6, 2013 /PRNewswire/ -- Vasomedical, Inc. ("Vasomedical") (OTC BB: VASO), a diversified medical technology company specializing in the design, manufacture and sale of medical devices for noninvasive cardiology including EECP® systems, the gold standard of ECP...
Abiomed Announces Revenue of $38.3 Million, Up 19% and Record Impella Patient Usage, Up 26%
February 6, 2013 3:44 am | by GlobeNewswire | News | CommentsAbiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2013 revenue of $38.3 million, up 19% compared to revenue of $32.2 million in the same period of fiscal 2012, on record quarterly patient usage, up 26% compared to the same period of fiscal 2012.
ZOLL Receives Shonin Approval from Japan to Market Intravascular Temperature Management Technology
February 6, 2013 12:05 am | by The Associated Press | News | CommentsCHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 6, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to enter the Japanese market with its Intravascular Temperature...
Thoratec Reports Fourth Quarter And Full Year Fiscal 2012 Financial Results
February 5, 2013 4:02 pm | by PR Newswire | News | CommentsPLEASANTON, Calif., Feb. 5, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today reported its financial results for the fourth quarter of 2012. "Thoratec...
Cook Medical Study of Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions Exceeds 50% Enrollment
February 5, 2013 9:03 am | by The Associated Press | News | CommentsBLOOMINGTON, Ind.--(BUSINESS WIRE)--Feb 5, 2013--With more than 100 patients enrolled, Cook Medical has exceeded 50 percent enrollment in the Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions trial. The first-of-its-kind, prospective, multicenter study is evaluating the retrograde...
MGC Diagnostics Corporation Announces National Jewish Health Selects the Company as Preferred Provider for Cardiopulmonary Diagnostic Instrumentation
February 5, 2013 8:00 am | by PR Newswire | News | CommentsSAINT PAUL, Minn., Feb. 5, 2013 /PRNewswire/ -- MGC Diagnostics Corporation (NASDAQ: MGCD) (formerly Angeion Corporation), a global medical technology company, today announced that National Jewish Health has selected MGC Diagnostics as its preferred provider of cardiopulmonary...
Pacemaker Payment Plans, Courtesy of Medtronic
February 5, 2013 7:29 am | by Mass Device | News | CommentsMedtronic offers patients in India the option to pay off a pricey cardiac implants in installments. Medtronic's (NYSE:MDT) India division is offering patients an "easy monthly installment" plan to help families cope with the high cost of cardiac implants. The EMI program is available in 60 hospitals in 18 cities and applies to a handful of medical devices...
Edwards Lifesciences Reports Strong Fourth Quarter Results
February 4, 2013 4:03 pm | by The Associated Press | News | CommentsEdwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per...
Medtronic Announces CE Mark of Evera® Portfolio of Implantable Cardioverter-Defibrillators
February 4, 2013 8:06 am | by The Associated Press | News | CommentsMedtronic today announced CE Mark of the Evera portfolio of implantable cardioverter-defibrillators. With increased longevity and the most advanced shock reduction technology available, the new family of ICDs is the first to feature the PhysioCurve design, a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30%.
St. Jude Announces First Implant Evaluating New Size of Portico Heart Valve in European Trial
February 4, 2013 8:00 am | by The Associated Press | News | CommentsSt. Jude Medical, Inc. announced the first patient implant of its 25 mm Portico Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial. The Portico valve system offers a minimally invasive treatment option for patients with severe aortic stenosis – a narrowing of the aortic valve that obstructs blood flow from the heart.
