Device Companies
Medtronic Completes Enrollment in Landmark U.S. Study of Symplicity Renal Denervation System for Treatment-Resistant Hypertension
May 23, 2013 6:06 am | by The Associated Press | News | CommentsMedtronic, Inc., today announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure.
One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology
May 23, 2013 4:15 am | by The Associated Press | News | CommentsST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 23, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN ™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after...
New Data Demonstrate Significant And Sustained Blood Pressure Reduction With Boston Scientific Vessix™ Renal Denervation System
May 22, 2013 12:20 pm | by PR Newswire | News | CommentsPARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today reported interim data from the REDUCE-HTN clinical program, which demonstrated a significant and sustained reduction in the blood pressure of patients treated with the Vessix™ Renal Denervation...
Stryker Metal Hip Recall: Lieff Cabraser Provides Answers to Hip Replacement Patients
May 22, 2013 10:00 am | by The Associated Press | News | CommentsNEW YORK--(BUSINESS WIRE)--May 22, 2013--Wendy Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the firm issued today a list of answers to frequently asked questions (FAQ) from hip replacement patients who received the Stryker Rejuvenate or...
St. Jude Medical EnligHTNment Study Highlighted at EuroPCR During Trials That May Change Clinical Practice Session
May 21, 2013 9:52 am | by The Associated Press | News | CommentsST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 21, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and...
Covidien’s Technology Platform to Diagnose Early Lung Cancer Part of New Guidelines of American College of Chest Physicians
May 21, 2013 6:59 am | by The Associated Press | News | CommentsMINNEAPOLIS--(BUSINESS WIRE)--May 21, 2013--Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its superDimension Electromagnetic Navigation Bronchoscopy (ENB™) system, the first technology of its kind, is included in the new American College of Chest...
Medtronic Finds TAVI with CoreValve System Cost Effective for Treating Patients with Severe Aortic Stenosis
May 21, 2013 4:06 am | by The Associated Press | News | CommentsFocused on offering devices that provide both clinical and economic value, Medtronic, Inc. unveiled the results of a cost-effectiveness model comparing transcatheter aortic valve implantation with the CoreValve System to medical management. Presented at EuroPCR 2013, the United Kingdom-based analysis compared the "real world" Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study.
Covidien Receives FDA 510(k) Clearance for Nellcor Pulse Oximetry Motion Claims
May 20, 2013 11:11 am | by Covidien | News | CommentsCovidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that its Nellcor™ pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for motion claims.
GE Scientists in Technology “Relay Race” Against Cancer
May 20, 2013 8:00 am | by The Associated Press | News | CommentsNISKAYUNA, N.Y.--(BUSINESS WIRE)--May 20, 2013--To commemorate National Cancer Research Month, a team of scientists from GE Global Research, the technology development arm of the General Electric Co. (NYSE: GE), are joined together in a technology “relay race” against cancer. They collectively are...
Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter
May 20, 2013 7:06 am | by The Associated Press | News | CommentsExpanding its portfolio of medical technology for the interventional treatment of cardiovascular disease, Medtronic, Inc. (NYSE: MDT) announced today that the Export Advance aspiration catheter recently received the CE (Conformité Européenne) mark and will soon be launched in Europe and other international markets.
GE Healthcare Unveils Exclusive Imaging Technology for Joint Replacements and Implanted Devices
May 15, 2013 4:33 pm | by Business Wire | News | CommentsAt an event held at Hospital for Special Surgery, GE Healthcare introduced MAVRIC SL, a novel magnetic resonance imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
Stryker Receives Top Supplier Awards From Novation
May 14, 2013 9:41 am | by The Associated Press | News | CommentsStryker's Sustainability Solutions division announced today it has received two prestigious awards from the group purchasing organization Novation for supplier excellence. Novation named Stryker's reprocessing division Purchased Services Supplier of the Year and presented it with top honors in...
St. Jude Medical Announces First Patient Enrollment in EnligHTN III Renal Denervation Study of Next-Generation EnligHTN System
May 14, 2013 8:00 am | by The Associated Press | News | CommentsST. PAUL, Minn.--(BUSINESS WIRE)--May 14, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced enrollment of the first patient in the EnligHTN III trial. This study will evaluate the safety and performance of the new second-generation EnligHTN ™ Renal...
Biventricular Pacing Reduces Symptoms and Improves Quality-of-Life
May 13, 2013 9:52 am | by Medtronic | News | CommentsMedtronic has announced new data demonstrating that simultaneously pacing the lower chambers of the heart, or biventricular (BiV) pacing with a cardiac resynchronization therapy (CRT) device, significantly improves heart failure symptoms and quality of life in a subset of heart failure patients.
Data Show Medtronic-Exclusive LIA Software Detects Non-Medtronic Lead Issues at a Greater Rate Than Standard Impedance Monitoring
May 10, 2013 4:06 pm | by The Associated Press | News | CommentsMINNEAPOLIS and DENVER - May 10, 2013 - Data presented today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions, show that Medtronic, Inc. (NYSE:MDT) Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a...
Medtronic Issues Statement on iPad Interference Study
May 10, 2013 11:02 am | by Medtronic | News | CommentsMedtronic'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.
Medical Device Global Labeling Strategies Conference
May 9, 2013 2:07 pm | by MDT Staff | EventsGain best practices in overcoming international labeling challenges at the Medical Device Global Labeling Strategies Conference, July 24-25, 2013 in Minneapolis, MN. This premier marcus evans event will bring together leading medical device labeling professionals to discuss how to successfully create a label on both a national and international scale.
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 | CommentsST. 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...
Covidien Unveils Innovative Capnography Solution for OEM Partners
May 9, 2013 10:16 am | by Covidien | News | CommentsCovidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, has launched the Microstream® MicroPod™ module. This is an important product for its Original Equipment Manufacturer (OEM) partners that will help hospitals improve patient safety by expanding access to capnography technology.
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 | CommentsST. 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...
Vast Majority of Americans Would Want to Know if They Have a Serious Illness or Injury, Even If There Is No Cure, New Survey Shows
May 7, 2013 9:14 am | by The Associated Press | News | CommentsMALVERN, Pa.--(BUSINESS WIRE)--May 7, 2013--Amidst ongoing national debate about healthcare costs, new research unveiled today by Siemens Healthcare shows that the vast majority of Americans (92 percent) agree that “the value of knowing exactly what is wrong with their health is as important as...
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 | CommentsMedtronic, 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).
St. Jude Medical Enrolls First Patient in Next-Generation Quadra Study
May 3, 2013 9:46 am | by Business Wire | News | CommentsSt. 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.
Olympus Introduces World's Only Fully Rotatable HD Bronchoscopes
May 2, 2013 11:44 am | by PRNewswire | News | CommentsOlympus, a precision technology leader in designing and delivering innovative Medical and Surgical solutions, among other core businesses, announced today the commercial availability of its 510(k) cleared BF-190 bronchoscopes. The new BF-190 bronchoscopes offer unparalleled maneuverability and flexibility through the combination of their unique Rotary Function and wider tip angulation...
Medtronic Reports Initial Implants of Novel Stent Graft for Aortic Aneurysms Involving Branch Vessel
April 29, 2013 4:32 pm | News | CommentsVascular specialists at Carolinas HealthCare System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed the initial implants of a novel stent graft system from Medtronic as part of a U.S. Food and Drug Administration initiative designed to encourage more early-stage clinical research on new medical devices in the United States.
