Spotlight On... Medtronic commences enrollment in trial of its CoreValve TAVR on low-risk patients; FDA 'corrects' 510(k) 19 years after it was issued; Medtronic makes a move to reduce its debt level; and more...

Medtronic ($MDT) announced that the first patients were enrolled in the clinical trial of use of its CoreValve Evolut R System on low-risk patients. Approval for use on low-risk patients would mean that TAVRs can be used on most patients with troubled aortic valves. Currently, the devices are indicated for use on high-risk patients, namely frail patients who are at risk of serious injury or death during invasive open heart surgery. At the upcoming meeting of the American College of Cardiology, the results of Edwards' intermediate-risk patient trial will be unveiled, with an expanded FDA indication for its Sapien TAVR franchise possible in in late 2016 or early 2017. Approval for use of TAVRs in low-risk patients is farther away, but the commencement of the clinical trial is a good start. More | ACC preview

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> Lawyers are concerned about FDA's proclivity for "correcting" 510(k) clearances, sometimes as long as 19 years after they have been issued. More

> Medtronic announced a cash tender offer worth up to $2.75 billion to reduce its indebtedness, which rose significantly following the $50 billion purchase of Covidien. More

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@EricPFierce: Japan's Daiichi Sankyo closing an API plant in with 150 workers. More from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: FTC digs deeper into Pfizer's proposed combo with Allergan. Article | Follow @CarlyHFierce

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