Medtronic (NYSE:MDT) today released new economic analysis data from the Fire and Ice trial comparing cryoballoon catheter ablation with radiofrequency ablation, touting advantages of cryoballoon treatment over RF. Data from the trial was presented at the Asia Pacific Heart Rhythm Society’s Scientific Sessions in Seoul. Primary results from the trial were published in The New […]
Medtronic
Medtronic wins MRI-safe nod from FDA for full suite of cardiac rhythm management devices
Medtronic (NYSE:MDT) said today that it won FDA approval for its full suite of MRI-safe cardiac rhythm and heart failure devices and leads for 3- and 1.5-Tesla scans, touting the approval as the 1st of its kind in the U.S. The regulatory win allows current patients with Fridley, Minn.-based Medtronic’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and […]
St. Jude Medical is only the latest medical device maker to face battery issues
The battery depletion issue confronting St. Jude Medical (NYSE:STJ) this week is only the latest such issue to bedevil a medical device maker, as its arch-rivals in the cardiac rhythm management space have issued their own recalls in recent years. St. Jude yesterday warned of the possibility that a battery issue could disable its high-voltage cardiac […]
Minn. Supreme Court to hear investors suit over Medtronic inversion
The Minnesota Supreme Court will hear a case from Medtronic (NYSE:MDT) shareholders who want the company to cover capital gains taxes related to the company’s inversion merger to Ireland last year. The aggrieved shareholders 1st must argue with the court that state law should not prevent them from pressing the 2-year-old class action lawsuit against […]
Misonix CEO steps down | Personnel Moves October 4, 2016
Misonix CEO steps down Misonix (NSDQ:MSON) CEO Michael McManus, Jr. stepped down in early September, also leaving his post as director and chairman of the board of directors. Stavros Vizirgianakis, a member of the board of directors, is serving as the interim CEO while negotiating for a full-time position in the corner office. Vizirgiankis, who owned […]
Medtronic touts 1-year data on Avalus surgical aortic valve
Medtronic (NYSE:MDT) today reported 1-year results from a clinical trial of its Avalus pericardial aortic surgical valve, touting low rates of adverse valve-related events and high survival numbers. Data from the study were presented at the European Assn. for Cardio-Thoracic Surgery’s annual meeting in Barcelona this week. “With more than 25 years of experience in the surgical valve space, […]
Medtronic’s HeartWare faces 2 Class I FDA recalls
Medtronic (NYSE:MDT) said today the FDA labeled 2 outstanding global voluntary recalls related to subsidiary HeartWare International‘s HVAD system as Class 1. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The voluntary recall is related […]
Medtronic issues urgent field safety notice for select ICDs, CRTds
Medtronic (NYSE:MDT) issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion. The Fridley, Minn.-based company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues […]
FDA approves Medtronic’s ‘artificial pancreas’ MinMed 670G hybrid closed loop system
The FDA today granted premarket approval to Medtronic (NYSE:MDT) for its MiniMed 670G ‘artificial pancreas’ hybrid closed loop system, making it the 1st system of its kind to win clearance globally. The MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]
Medtronic touts 1st-in-human use of Sugar.IQ with Watson ‘cognitive app’
Medtronic (NYSE:MDT) said today it launched its Sugar.IQ with Watson ‘cognitive app’ for people living with diabetes. The 1st users participating in the testing of the final release candidate will provide information about the app’s usability and function, the Fridley, Minn.-based company said. The Sugar.IQ app was developed to integrate Medtronic’s continuous glucose monitoring sensors with IBM (NYSE:IBM) Watson […]