The North American Free Trade Agreement may not be facing the gallows after the Trump administration this week said it does not plan to terminate it – but changes to the deal could have a huge impact on the medical device industry, according to a New York Times report. This week, Trump spoke with Mexican […]
Medtronic
Medtronic wins Health Canada nod for OsteoCool RF ablation system
Medtronic (NYSE:MDT) said today it won Health Canada approval for its OsteoCool radiofrequency ablation system for treating cancers that metastasize to the spine, and launched the system in the region. The Fridley, Minn.-based company touted the OsteoCool system as the only cooled RF ablation technology with simultaneous, dual-probe capabilities. “Our pain therapies business is deeply […]
Report: India rejects Medtronic, Abbott requests to withdraw select stents
The Indian National Pharmaceutical Pricing Authority today rejected applications from Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) to withdraw coronary stents from the region and asked the companies to maintain their supplies of the stents, according to a DNAIndia report. Earlier this week, Medtronic and Abbott said they would look to withdraw select high-value stents from the Indian market in […]
Medtronic touts long-term data from VenaSeal studies
Medtronic (NYSE:MDT) touted 3-year outcomes from a pivotal clinical trial and 1-year data from the Waves study of its VenaSeal closure system in patients with venous reflux disease. Dr. Kathleen Gibson, from Lake Washington Vascular, presented the data at the 2017 Charing Cross Symposium. Both studies demonstrated long-term clinical benefits and improvement in quality of […]
Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 […]
Medtronic touts drug-coated balloon in peripheral artery disease patients
Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London. Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with […]
Medtronic launches StealthStation S8 neurosurgery navigator
Medtronic (NYSE:MDT) said today it launched the next-gen S8 version of its StealthStation neurosurgical intraoperative imaging and navigation system The StealthStation S8 includes upgrades to its software interface, a 2-cart platform design and electromagnetic technology, the Fridley, Minn.-based company said. “Neuro-navigation and computer-based surgical guidance has become a standard part of neurosurgery practices today. The StealthStation […]
Report: Medtronic, Abbott to withdraw select stents from Indian market
Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) are withdrawing select high-value stents from the Indian market following cost caps imposed by the Indian National Pharmaceutical Pricing Authority, according to a Financial Express report. Medtronic has filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents. Last […]
FDA labels Medtronic StrataMR recall as Class I
The FDA today released updated information on Medtronic‘s (NYSE:MDT) recall of StrataMR adjustable valves and shunts over issues with fluid buildup, labeling it as Class I. The StrataMR adjustable valves and shunts are intended for the management of hydrocephalus by providing cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the […]
Medtronic updates 2011 warning on Synchromed II implantable drug pumps
Medtronic (NYSE:MDT) this month updated physicians on a warning it 1st issued in July 2011 about the batteries in its SynchroMed II implantable drug infusion pump. The pumps are used primarily to treat chronic pain or severe spinal or cerebral spasticity. The issue, 1st reported in July 2009, relates to the formation of a filmy substance within the […]
Medtronic updates on HVAD recall, FDA labels as Class I
Medtronic (NYSE:MDT) said today that the FDA has classified its recent voluntary field action recall for its HVAD heart pump system controllers as Class I, and the company updated on its steps to correct issues related to the recall. Class I recall designations, the agency’s most serious classification of recall, are used when there is […]