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, Inc. announced it has received CE (Conformité Européenne) 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.
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...
Medtronic Approved to Update Resolute Integrity Stent’s CE Mark Labeling on Dual Antiplatelet TherapyMarch 4, 2013 10:27 am | by Medtronic | News | Comments
Of relevance to the clinical practice of interventional cardiology, Medtronic announced that it has received regulatory approval to update the CE mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy, the shortest minimum duration referenced on the label for any device of its kind.
Medtronic's Irish subsidiary posts 119% pre-tax profit growth on a 43% sales increase. One of the largest employers on the Emerald Isle, Medtronic (NYSE:MDT), saw its Irish subsidiary's pre-tax profits surge 119% during its last fiscal year, on sales growth of 43%.
Medtronic, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever FDA approval of an investigational device exemption (IDE) following the new draft FDA guidance for early feasibility studies.
Medtronic is once again backing sinus implant developer Intersect ENT, this time in a $30 million Series D round led by new investor Norwest Venture Partners. All of Intersect's existing "significant" backers participated in the latest round, including Kleiner Perkins Caufield & Byers, U.S. Venture Partners, PTV Sciences and Medtronic, according to a press release.
Medtronic joins fellow medical device giants in forecasting lower 2013 medtech tax costs than previously anticipated. Medical device maker Medtronic (NYSE:MDT) this week became the latest in a string of medtech giants who have pared back their expectations of the impact of the 2.3% medical device sales tax.
Medtronic posted profit and sales gains during its fiscal 3rd quarter this morning, eating Wall Street analysts' earnings expectations along the way. The Fridley, Minn.-based company, which is the world's largest pure-play medical device company, said profits were up 5.7% on sales growth of 2.8% for the 3 months ended Jan. 25.
Medtronic 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...