Medtronic's Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply.
Medtronic added 2% in early trading after it reported its first earnings since the close of the Covidien acquisition. Recent product launches across business groups helped push it to beat consensus earnings for the quarter by $0.04 at $1.01 and top revenue estimates at $4.32 billion versus the $4.26 billion expectation.
Groundbreaking studies offer more evidence that revascularization devices that physically remove blood clots from the brain are a valuable and potentially lifesaving addition to pharmaceutical therapy in stroke patients.
Medtronic scored its first new FDA approval resulting from the acquisition of Covidien, which closed less than two weeks ago. The nod is for Pipeline Flex, a next-generation minimally invasive flow diversion device for unruptured aneurysm. It comes from Covidien's fast-growing, but tiny, neurovascular group.
Welch Allyn has partnered with Nonin Medical for its blood oxygen level measurement technology, PureSAT SpO2. It plans to use this technology alongside others to create a next-generation vital sign device that's intended to enable customized vital sign capture, interval monitoring and wireless transfer of patient data to an electronic medical record.
More than 1,000 of Medtronic's Trellis Peripheral Infusion Systems have misidentified balloon ports on the device itself, which could result in fatal errors, leading the FDA to issue its most serious type of recall on both models of product.
In the wake of the closure of Medtronic's mega, nearly $50 billion purchase of Covidien, CEO Omar Ishrak announced that the company will give $10 to charity for every email he receives from an employee containing reflections on the company's mission to restore health, alleviate pain and extend life.
Weeks after Medtronic and Covidien won shareholder approval for their $43 billion merger, the companies expect to finalize the deal today after the Irish High Court signed off on the pending acquisition.
Covidien today announced the CE mark granted for its Stellarex drug-coated balloon for peripheral artery disease. In addition to physically displacing the lesion with angiopolasty, Stellarex delivers the drug paclitaxel like many of its European competitors.