Medtronic (NYSE:MDT) yesterday disputed a newspaper’s report about an internal review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, saying the piece made false insinuations and omitted key facts. The Minneapolis Star Tribune reported yesterday that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– […]
Medtronic
FDA clears Medtronic’s miniature Micra transcatheter pacer
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker. The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle […]
Medtronic still unfazed by new inversion rules
Medtronic (NYSE:MDT) remains unfazed by the U.S. Treasury Dept.’s push to rein in so-called “inversion” mergers, which allow American companies to re-organized under foreign jurisdictions, after the agency issued new rules on the deals this week. The U.S. government has grappled with a wave of inversions in recent years, including last year’s $50 billion union of Medtronic and Covidien, […]
Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Medtronic’s Resolute Integrity stent tops Abbott’s Xience in Propel all-comers study Results from the Propel all-comers trial comparing Medtronic‘s (NYSE:MDT) Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made by rival Abbott (NYSE:ABT). The 1-year study followed 800 patients from the Propel trial who were treated with the Resolute Integrity device, […]
Boston Scientific’s Synergy stent at 2 years | ACC 2016 roundup
Evolve II: 2-year data for Boston Scientific’s Synergy stent Boston Scientific‘s (NYSE:BSX) Synergy stent showed non-inferiority to its Promus Element Plus device after 12 months, according to data from the Evolve II trial presented yesterday at the annual conference of the American College of Cardiology. The Synergy stent’s bioresorbable polymer coating is designed to dissolve completely […]
Fire & Ice: Medtronic’s Arctic Front ablation catheter as good as BioSense Webster’s ThermoCool | ACC 2016
Results from a clinical trial presented today at the annual meeting of the American College of Cardiology showed that the Arctic Front ablation catheter made by Medtronic (NYSE:MDT) is noninferior to Johnson & Johnson (NYSE:JNJ) subsidiary BioSense Webster’s ThermoCool device in treating atrial fibrillation. The Fire & Ice study compared Arctic Front’s cryoballoon ablation technique with the […]
Medtronic touts more early data from drug-filled stent study | ACC 2016
Medtronic (NYSE:MDT) yesterday touted early data from a clinical study of its drug-filled stent aimed at winning CE Mark approval in the European Union. The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using its “continuous sinusoid” and CoreWire technologies. It’s made with a “tri-layer” wire design in which the innermost […]
Medtronic wins expanded indication for Pillcam Colon 2
Medtronic (NYSE:MDT) said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year. The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if […]
Medtronic launches Nuro overactive bladder treatment
Medtronic (NYSE:MDT) said today it launched its Nuro system designed for treating overactive bladder with symptoms of urinary urgency, urinary frequency and urge incontinence. The Fridley, Minn.-based company said the device is designed to deliver percutaneous tibial neuromodulation treatment, a minimally invasive office-based procedure which provides a “measurable reduction” in urinary frequency or urinary incontinence. “Many people with […]
Medtronic to shift product lines from Colorado plant
Medtronic (NYSE:MDT) is planning to move a pair of product lines from a plant in Colorado to other facilities, a spokesman told MassDevice.com today. Fridley, Minn.-based Medtronic acquired the lines when it paid $50 billion for Covidien in January 2015. Spokesman John Jordan told us that the plant in Boulder, Colo., makes surgical energy return pads and electro-surgical pencils. […]
Judge: Doc can’t drag Globus into patent spat with Medtronic
A doctor suing Medtronic (NYSE:MDT) for allegedly infringing his patents covering spinal deformity repair devices can’t drag Globus Medical (NYSE:GMED) into the dispute, a federal judge in Pennsylvania ruled last week. Dr. Mark Barry sued Medtronic in February 2014 in a Texas federal court, alleging infringement of a trio of patents covering a “System and method for aligning vertebrae in […]