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medtronic inc (MDT) Key Developments

Medtronic, Inc. Announces Results from End-Stage Renal Disease Study

Medtronic, Inc., has announced results from a new study which found that atrial fibrillation, or AF, and bradycardia occurred at higher than expected, and clinically significant, rates in patients with end-stage renal disease, or ESRD, undergoing hemodialysis. Moreover, these worrisome rhythm disorders appeared to correlate with patients' dialysis cycles, occurring immediately before, during and after their dialysis sessions. The irregular heartbeats were found in the Monitoring in Dialysis (MiD) Study using the Medtronic Reveal XT Insertable Cardiac Monitor (ICM).

Medtronic, Inc. Launches Abdominal Aortic Aneurysm Treatment in Europe and US

Medtronic, Inc. has launched the Endurant IIs AAA stent graft, which is used in the minimally invasive treatment for abdominal aortic aneurysms, in Europe and the US. The Endurant AAA stent graft system has been used more than any other, being selected for nearly one of every two endovascular procedures to repair abdominal aortic aneurysms around the world. The Endurant IIs stent graft is a new bifurcated component for the system that leverages the proven design of the predicate device and expands the system's anatomical customization options. The new device is designed to be used as part of a three-piece configuration. The Endurant IIs stent graft: features equal leg diameters to allow limbs to be used on either side; offers a shorter (50mm) ipsilateral leg for more flexible targeted limb placement; enables in situ sizing with select ipsilateral limbs, allowing a 3-5 stent overlap for adjustment during the implant procedure; provides up to a 20% reduction in distal diameter compared to select Endurant II stent grafts; and allows easier pre-case planning by simplifying sizing decisions. The new device complements the existing Endurant II stent graft, which remains an integral part of the product portfolio and already accommodates a wide range of anatomies. The Endurant II and Endurant IIs stent grafts use the same delivery system, which allows for accurate placement and controlled deployment of the device within the aorta.

Medtronic, Inc. Presents at Emerging Medical Technologies Summit, Nov-12-2014 09:45 AM

Medtronic, Inc. Presents at Emerging Medical Technologies Summit, Nov-12-2014 09:45 AM. Venue: Sofitel Hotel San Francisco, 223 Twin Dolphin Dr., Redwood City, CA 94065, United States. Speakers: Gary Brothers, Sr. Corporate Development Director.

Medtronic Announces Japanese Approval and Launch of Implantable Cardioverter-Defibrillator System to Allow for Full-Body MRI Scans

Medtronic announced Japanese regulatory approval and launch of the Evera MRI SureScan implantable cardioverter-defibrillator System for magnetic resonance imaging scans positioned on any region of the body. Reimbursement also was approved by Japan's Ministry of Health, Labor and Welfare. The Medtronic Evera MRI ICD is currently limited to investigational use in the United States. It is estimated that more than half of ICD patients will need an MRI within 10 years of receiving a device. Until the availability of MR-Conditional ICD systems, patients with devices have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function. The newly-approved Evera MRI device is available in both single chamber and dual chamber ICDs. Like its non-MR-Conditional predecessor, the Evera MRI features a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30%. The Evera MRI maintains the same industry-lead battery longevity (up to 11 years) compared to previous devices. In addition, Evera MRI is paired with the Sprint Quattro Secure family of ICD leads, which has 10 years of proven performance with active monitoring 11 and is safe for use in an MRI environment. Evera MRI includes SmartShock 2.0 - an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20% of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98% inappropriate shock free rate at one year. Also included in the Evera MRI is OptiVol 2.0 Fluid Status Monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation. The Evera MRI system is the latest addition to a growing number of Medtronic devices which are designed for MRI access including the Medtronic SureScan pacing systems, neurostimulation systems for the management of chronic pain and the SynchroMed II programmable drug infusion system.

Medtronic Launches Resolute Onyx Drug-Eluting Stent Following CE Mark

Medtronic, Inc. announced CE (Conformite Europeene) mark and international launch of the Resolute Onyx(TM) Drug-Eluting Stent (DES). The first live patient implant of the Resolute Onyx DES occurred recently during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain. The Resolute Onyx Drug-Eluting Stent is not approved in the United States. Built on the proven clinical performance and superior deliverability of the Resolute Integrity DES, the Resolute Onyx DES is the first stent to feature a new advancement called CoreWire Technology that allows it to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity (i.e., visibility during the procedure) and the Resolute Onyx DES has thinner struts to help improve deliverability without compromising radial and longitudinal strength. Resolute Onyx DES features a new delivery system with PowerTrac(TM) technology that was introduced earlier in the year 2014 with the NC Euphora(TM) Noncompliant Balloon Dilatation Catheter. The advanced delivery system provides superior and enhanced deliverability through challenging lesions. Available in a broad size matrix (including a new 2.0 mm diameter), the CE mark labeling for Resolute Onyx DES includes information on one month of dual antiplatelet therapy (DAPT). The Resolute Onyx DES is now available in select countries that recognize the CE mark.


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