In its annual 10-K filing with the SEC, Covidien quietly noted that it is under a federal subpoena related to some of its peripheral vascular products.
Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.
Medtronic's fastest growing business is in diabetes, which gained 10% to $430 million in the most recent quarter over a year ago. Now the medical device giant is looking to expand beyond its dominance in Type 1 diabetes that is based on the success of its insulin pump MiniMed. During an earnings call, Medtronic disclosed that it reorganized its diabetes group last quarter.
Dialysis provider DaVita HealthCare Partners has partnered with Medtronic for a pilot program to study cardiac arrhythmias in end-stage renal disease patients receiving dialysis. It will use the tiny implantable cardiac monitor, Linq, which Medtronic launched early this year.
Medtronic's $43 billion acquisition of Covidien has become increasingly expensive, requiring the medical device giant to borrow more than $16 billion, the company said in a massive regulatory filing.
Medtronic submitted concessions to the European Union regulatory commission last Friday. The antitrust authority will decide by Nov. 28 whether to clear the deal.
The FDA has hit Covidien's Puritan Bennett 980 Ventilator Systems with its most severe Class I recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Covidien CEO José Almeida said during the company's fiscal Q4 earnings call that the company's looming megamerger with Medtronic will give the combined entity "a voice at the table" due to its volume in some of the most purchased devices in the world.
Covidien won FDA 510(k) clearance for its directional atherectomy devices for peripheral artery disease, a notch in the company's belt as it anticipates the close of its pending $43 billion deal with Medtronic.
Another hurdle toward the long-anticipated closure of Covidien's $43 billion merger with Medtronic was crossed today. Covidien announced that it is selling its clinical-stage Stellarex drug-coated angioplasty balloon for peripheral artery disease to Spectranetics for $30 million.