Continuing to demonstrate its ongoing commitment to advancing interventional treatments of peripheral artery disease and the evidence to support their adoption, Medtronic, Inc. announced today that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company's U.S. regulatory approval submission of the novel angioplasty device.
The Endurant AAA stent graft system from Medtronic, Inc. continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up.
Medtronic, Inc. (NYSE: MDT) is expanding its market-leading portfolio of products for endovascular aortic repair in the United States with two new medical devices: the company recently received approval from the U.S. Food and Drug Administration (FDA) for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA’s 510(k) clearance for the Sentrant Introducer Sheath.
Medtronic Completes Enrollment in Landmark U.S. Study of Symplicity Renal Denervation System for Treatment-Resistant HypertensionMay 23, 2013 6:06 am | by The Associated Press | News | Comments
Medtronic, 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.
Medtronic Finds TAVI with CoreValve System Cost Effective for Treating Patients with Severe Aortic StenosisMay 21, 2013 4:06 am | by The Associated Press | News | Comments
Focused 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.
Expanding 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.
Medtronic 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 MonitoringMay 10, 2013 4:06 pm | by The Associated Press | News | Comments
MINNEAPOLIS 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'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.
Gain 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.
Medtronic Announces FDA Approval of New Portfolio Of Next-Gen Cardiac Resynchronization Therapy Devices, Implantable Cardioverter-DefibrillatorsMay 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).
Medtronic Reports Initial Implants of Novel Stent Graft for Aortic Aneurysms Involving Branch VesselApril 29, 2013 4:32 pm | News | Comments
Vascular 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.
BROOMFIELD, Colo.--(BUSINESS WIRE)--Apr 22, 2013--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (NYSE:MDT), a leader in medical...
Medical device company Medtronic confirmed today that there are layoffs ahead for its spinal business, affecting an undisclosed number of workers at various locations. The medtech titan doesn't plan to release details until next month, but rumors are already swirling that a Warsaw, Ind., spinal facility may lose as many as 50 workers.
American College of Cardiology Journal Publishes Outcomes of Diabetes Patients Treated with Medtronic's Resolute StentApril 15, 2013 9:06 am | by The Associated Press | News | Comments
The current issue of JACC: Cardiovascular Interventions, a peer-reviewed journal published by the American College of Cardiology, includes an article that describes how the Resolute Integrity drug-eluting stent from Medtronic became the first and only device of its kind to be approved by the FDA with a specific indication for treating the coronary artery disease of patients with diabetes mellitus.
Medtech titan Medtronic enrolled the initial patients in its SubQStim II pivotal clinical trial, evaluating the use of peripheral nerve stimulation in treatment of chronic back pain. The new study is the latest in a handful of neurostimulation trials launched by the medical device giant as it continues to battle rivals in the market for neurostimulation systems that treat chronic pain.
Presented to endovascular specialists at the 35th Charing Cross International Symposium in London, a new analysis of clinical data on the Endurant AAA Stent Graft System from Medtronic demonstrates the implanted medical device’s consistent and compelling performance in treating abdominal aortic aneurysms across a range of patient anatomies.
Medtronic said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs. The Minneapolis-area medical device company, which is the world's largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient's blood to remove particles and air during oxygenation.
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.
With Medtronic Resolute Stent, Interrupting Dual Antiplatelet Therapy After One Month Showed No Increased Safety Risk in Robust AnalysisMarch 11, 2013 12:18 pm | by The Associated Press | News | Comments
Cardiologists 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.
New Data Reinforce Significant Blood Pressure Reduction Sustained to Two Years Using the Symplicity(TM) Renal Denervation SystemMarch 10, 2013 12:18 pm | by The Associated Press | News | Comments
Medtronic, 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.
Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160 mm HgMarch 7, 2013 10:19 am | by The Associated Press | News | Comments
Medtronic, announced today that the company has submitted an Investigational Device Exemption to the U.S. FDA to study the Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg despite treatment with three or more anti-hypertensive medications of different classes.
Group purchasing organization Premier Healthcare Alliance struck a deal with 4 major players in the cardiac device market for several cardiac rhythm management device portfolios. Boston Scientific, Biotronik, Medtronic, and Oscor have all agreed to make certain CRM devices available to customers in the Premier network.
Symplicity(TM) Renal Denervation System One of First Devices Accepted to Participate in Concurrent Review for Joint FDA Premarket Approval and Medicare National Coverage DeterminationMarch 6, 2013 12:18 pm | by The Associated Press | News | Comments
Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have accepted the inclusion of the Symplicity(TM) renal denervation system for treatment-resistant hypertension in their parallel review program...
Medtronic announced it has received a CE Mark and will begin the European launch of the Attain Performa portfolio of quadripolar leads. Paired with Medtronic Viva/Brava Quad cardiac resynchronization therapy defibrillators, Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies...