The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
San Clemente, Calif.-based ICU Medical Inc. has acquired Minneapolis-based Pursuit Vascular Inc. for $75 million and an additional, undisclosed earn-out payment that would be due in 2021. In the deal, it gains the Clearguard HD Antimicrobial Barrier Cap, which is the only U.S.-marketed device that's been shown to reduce central line-associated bloodstream infections in hemodialysis patients.
The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.
LONDON – Quanta Dialysis Technologies Ltd. has raised £38 million (US$46.7 million) in the first close of a series C round, to fund a U.S. FDA 510(k) submission and U.K. commercial launch of its SC+ home hemodialysis system. With the cash now in hand, both these events are due to occur before the end of 2019. "We've got a lot of work to do," said John Milad, CEO of Quanta. "This is the rocket fuel."