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Medtronic Issues Statement on iPad Interference Study

May 10, 2013 11:02 am | by Medtronic | News | Comments

Medtronic's current internal analysis and testing shows iPad technology presents no risk of electromagnetic interference with Medtronic implantable cardiac rhythm devices when used per manufacturer's instructions. However, as a precaution, patients implanted with a pacemaker or ICD are advised to follow Apple and Medtronic labeling recommendations and maintain a distance of six inches between the iPad and implanted device.

Operating Without Interrupting Warfarin Reduces Risk of Bleeding After Cardiac Device Surgery

May 10, 2013 10:21 am | by University of Ottawa Heart Institute | News | Comments

A new Canadian study shows that operating without interrupting warfarin treatment at the time of cardiac device surgery is safe and markedly reduces the incidence of clinically significant hematomas compared to the current standard of care. The new findings were released today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.

Weaving Flexibility and Strength into Stent Design

May 9, 2013 3:05 pm | by Kasey Panetta, Managing Editor, ECN | Articles | Comments

Though traditional laser-cut stents made from nitinol are effective, the design trades flexibility for strength, which means the stents are at risk for fracture, crushing, and kinking. This is a particular issue when the stents are used with patients suffering from femoropopliteal or proximal popliteal artery disease.

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St. Jude Medical Announces Results from Independent Analysis of Optim-Insulated Defibrillation Leads in Late-Breaking Clinical Trial Session at Heart Rhythm 2013

May 9, 2013 1:55 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 9, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the Population Health Research Institute (PHRI), an academic health science research institute, has conducted a further independent analysis of data received from...

New Four-Year Data From Boston Scientific Demonstrated WATCHMAN Device Was Superior To Warfarin For Mortality And Primary Efficacy In Patients With Atrial Fibrillation In Long Term Follow-Up Of The PROTECT AF Trial

May 9, 2013 12:02 pm | by The Associated Press | News | Comments

Boston Scientific Corporation (NYSE: BSX) reports that the four-year follow-up data from the PROTECT AF clinical trial demonstrated the WATCHMAN@ Left Atrial Appendage (LAA) Closure device was statistically superior to warfarin for preventing cardiovascular death, all-cause stroke and systemic...

First Patient Enrolled in reMARQable Clinical Study Evaluating the Safety and Efficacy of Multi-Electrode nMARQ™ Pulmonary Vein Isolation System™ in the Treatment of Paroxysmal Atrial Fibrillation

May 9, 2013 9:49 am | by The Associated Press | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--May 9, 2013--Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, today announced the first patient has been enrolled in the reMARQable clinical study. ReMARQable will assess the safety and efficacy of the use of...

Thoracic Endografts Used Successfully to Remove Tumors Invading the Aorta

May 8, 2013 10:43 am | by American Association for Thoracic Surgery | News | Comments

Some chest tumors may invade one of the great vessels of the body, the aorta. Surgical removal of these tumors is very challenging and necessitates the support of a heart-lung machine. Therefore, there is an increased risk of complication and death. In a small series of patients, placing a stent within the aorta facilitated the subsequent removal of tumor and eliminated the need for heart-lung bypass.

Heart Rhythm 2013 - ScottCare Launches Innovations in Universal Management of Cardiac Implantable Electronic Device (CIED) Data

May 8, 2013 9:00 am | by The Associated Press | News | Comments

CLEVELAND--(BUSINESS WIRE)--May 8, 2013--As a technology leader in devices and software for cardiology diagnosis, therapy and rehabilitation, ScottCare will unveil new advances in importing, monitoring and reviewing CIED data at this year’s Heart Rhythm Society’s Scientific Session, Heart Rhythm...

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St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices

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

ST. PAUL, Minn.--(BUSINESS WIRE)--May 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy...

Elixir Medical Announces FDA Approval to Commence EXCELLA III Clinical Trial with DESyne® Nx Novolimus Eluting Coronary Stent System in the United States

May 8, 2013 7:00 am | by The Associated Press | News | Comments

SUNNYVALE, Calif--(BUSINESS WIRE)--May 8, 2013--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration (FDA) to initiate patient enrollment...

Demand for Hybrid Solutions to Spur European Interventional Radiology and Cardiology Markets, finds Frost & Sullivan

May 8, 2013 4:00 am | by PR Newswire | News | Comments

LONDON, May 8, 2013 /PRNewswire/ -- The European market for interventional radiology and cardiology is heading towards maturity, especially in Western Europe. Although the economic slowdown and fewer orders had a negative impact on revenues in 2012, it is expected that expanding...

A Living Patch for Damaged Hearts

May 7, 2013 10:10 am | by Duke University | News | Comments

Duke University biomedical engineers have grown three-dimensional human heart muscle that acts just like natural tissue. This advancement could be important in treating heart attack patients or in serving as a platform for testing new heart disease medicines.

FDA Approves BIOTRONIK’s Ilesto 7 ICD/CRT-D Series

May 7, 2013 10:02 am | by The Associated Press | News | Comments

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--May 7, 2013--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced that the Food and Drug Administration (FDA) granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator...

Enrollment Completed for Low-Risk Aortic and Mitral Patient Groups For On-X® Prosthetic Heart Valve Anticoagulation Clinical Study

May 7, 2013 9:00 am | by The Associated Press | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--May 7, 2013--On-X ® Life Technologies, Inc. (On-X LTI) announced today that enrollment for the Low-Risk Aortic Valve and Mitral Valve Patient Groups has been completed. The Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) was initiated with US FDA...

The Future of Energy-Based Surgical Systems

May 6, 2013 2:43 pm | by Steven Walsh, Ph.D., VP of R&D, and Nikolay Suslov, Ph.D., EVP and CTO, Plasma Surgical | Blogs | Comments

Unique energy-based surgical devices afford broad clinical use in the cutting, coagulation, and ablation of tissues using a high velocity jet of thermal plasma, and the PlasmaJet surgical system is one example of this medical device evolution. Plasma is formed when sufficient energy is added to remove outer electrons from a gas to form ions.

Medtronic Announces FDA Approval of New Portfolio Of Next-Gen Cardiac Resynchronization Therapy Devices, Implantable Cardioverter-Defibrillators

May 6, 2013 10:18 am | by Medtronic | News | Comments

Medtronic, Inc. has announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of its newest cardiac devices: the Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

AATS Report: Prospective Randomized On-X Heart Valve Clinical Trial (PROACT) Provides Evidence of Reduced Complications

May 6, 2013 9:00 am | by The Associated Press | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--May 6, 2013--On-X ® Life Technologies, Inc. (On-X LTI) announced today that interim results for the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) are being presented at the American Association for Thoracic Surgery Annual (AATS) meeting by John...

AG Mednet Announces Partnership with The Methodist DeBakey Heart & Vascular Center Echocardiography Core Lab

May 6, 2013 9:00 am | by PR Newswire | News | Comments

BOSTON, May 6, 2013 /PRNewswire/ -- AG Mednet today announced a new core lab partnership with the Methodist DeBakey Heart & Vascular Center (MDHVC) echocardiography core laboratory at The Methodist Hospital in Houston. By selecting AG Mednet quality assurance and compliance...

Hansen Medical to Exhibit Magellan Robotic System at 8th Annual European Symposium of Vascular Biomaterials in France

May 6, 2013 8:03 am | by The Associated Press | News | Comments

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will be exhibiting its Magellan™ Robotic System at the 8th Annual European Symposium of Vascular Biomaterials (ESVB) from Friday, May 10th to Monday, May 13th at the Strasbourg Hilton in...

Atrium Medical Announces 1-year results of the INFUSE-AMI Trial

May 3, 2013 1:00 pm | by PR Newswire | News | Comments

HUDSON, N.H., May 3, 2013 /PRNewswire/ -- Atrium Medical Corporation, a business unit of MAQUET Cardiovascular, today announced the 1-year results of the INFUSE-AMI (Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. Dr. Gregg Stone, the...

Researchers Determine Where Best to Place Defibrillators

May 3, 2013 9:55 am | by University of Toronto Faculty of Applied Science & Engineering | News | Comments

Prompt use of an automated external defibrillator, or AED, can greatly increase the survival rates of people who suffer a cardiac arrest. And MIE Professor Tim Chan, working with Dr. Laurie Morrison at St. Michael's Hospital, has developed a formula to determine where best to place these costly but life-saving devices.

St. Jude Medical Enrolls First Patient in Next-Generation Quadra Study

May 3, 2013 9:46 am | by Business Wire | News | Comments

St. Jude Medical, a global medical device company, today announced first enrollment of its MultiPoint Pacing clinical study to build upon its first- to-market Quadripolar Pacing System. Patients will be implanted with the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) and Quartet lead to assess pacing in multiple locations in the heart.

Kips Bay Medical Announces the First eSVS Mesh Implant by the Mayo Clinic

May 3, 2013 9:37 am | by Business Wire | News | Comments

Manny Villafaña, Chairman and CEO of Kips Bay Medical announced that on April 30, 2013, the Mayo Clinic performed its first implant of an eSVS Mesh at its Rochester, Minnesota facility. This implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the U.S. FDA in a number of preeminent cardiac surgery centers in both Europe and the United States.

Laser-Structured, High-Performance Polymers are Ideal Combination for Miniaturization

May 2, 2013 3:12 pm | by Anthony Verrocchi, Technical Marketing Engineer, Ticona Engineering Polymers | Ticona Engineering Polymers | Blogs | Comments

Miniaturization of medical devices is dependent upon the reliability of their assembled components, which is crucial for proper functioning devices. Miniaturization creates material challenges—especially in electronic medical device applications such as implantable cardiac devices.

Robotic Angioplasty Achieves 97.6 Percent Clinical Success Rate

May 2, 2013 2:39 pm | by Business Wire | News | Comments

Corindus Vascular Robotics, a leading developer of precision vascular robotics, has announced that the Journal of American College of Cardiology published the results from its CorPath PRECISE study in the April 2013 issue. Results of the trial demonstrate the CorPath System is safe and feasible for patients, with significantly lower harmful radiation exposure to the operator.

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