Baxter (NYSE:BAX) said today that it’s launching a clinical trial of the Vivia home hemodialysis device it’s co-developing with famed inventor Dean Kamen’s DEKA Research & Development Corp. The Vivia system is designed to provide shorter but more frequent dialysis rounds than conventional dialysis. The device has already won CE Mark approval in the European Union for use with […]
Dialysis
Fresenius, plaintiffs ask for more time for $250m settlement in dialysate cases
Fresenius Medical Care (NYSE:FMS) and the plaintiffs in a spate of lawsuits brought over its GranuFlo and NaturaLyte dialysis drugs yesterday asked a federal judge in Massachusetts to stay the case so they can finalize their $250 million settlement deal. The deal, brokered with a committee of plaintiffs’ representatives, requires that 97% of all patients who brought lawsuits sign […]
NxStage touts home hemodialysis studies
NxStage Medical (NSDQ:NXTM) today touted data from studies of its Nx2me connected health technology and home hemodialysis systems, which the company plans to present at the 2016 Annual Dialysis Conference in Seattle later this month. In a study of 328 patients treated with the company’s HHD using its Nx2me platform, NxStage reported a 44% reduction […]
Fresenius misses the mark with Q4, 2015 results
Fresenius Medical Care (NYSE:FMS) reported 4th-quarter and 2015 results today that missed the mark on Wall Street, sending share prices down. The German dialysis giant posted profits of $394 million, or $1.04 per share, on sales of $3.55 billion for the 3 months ended Dec. 31, 2015, for a bottom-line slide of -2.2% on sales growth […]
Fresenius to settle dialysate lawsuits for $250m
Fresenius Medical Care (NYSE:FMS) said yesterday that its North American subsidiary agreed in principle to a $250 settlement of the multi-district litigation brought over its GranuFlo and NaturaLyte dialysis drugs. The deal, brokered with a committee of plaintiffs’ representatives, requires that 97% of all patients who brought lawsuits sign on by July. If that bar is met, Fresenius Medical […]
CryoLife deals Hero graft to Merit Medical for $19m
CryoLife Inc. (NYSE:CRY) said today that it dealt its Hero hemodialysis access graft to Merit Medical (NSDQ:MMSI) for $18.5 million in cash. The Hero graft put up $7.5 million in sales for CryoLife last year, the Atlanta-based company said. The deal calls for CryoLife to continue manufacturing the device for up to 6 months, when Salt Lake […]
Medtronic gets into renal care with Bellco acquisition
Medtronic (NYSE:MDT) said today that it acquired renal care products make Bellco for an undisclosed amount and plans to fold it into a newly created renal care solutions division. Fridley, Minn.-based Medtronic said Mirandola, Italy-based Bellco makes devices designed to treat end-stage renal failure, multiple organ failure and sepsis, including dialyzers and chronic and acute dialysis machines. The […]
ExThera wins nod for CE Mark trial for Seraph blood filter
ExThera Medical said it won approval for a CE Mark trial for its Seraph blood filter, which is designed to remove pathogens from the bloodstream. Berkeley, Calif.-based ExThera said Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte approved the protocol for a trial of the Seraph device in treating dialysis patients with Staphylococcus aureus and MRSA bloodstream infections. “Certain bloodstream […]
Debiotech, Fresenius partner to develop home dialysis tech
Swiss med device firm Debiotech and dialysis device developer Fresenius Medical said today they are partnering to develop home-usable peritoneal dialysis technologies. The companies said they aim to create a platform of dialysis machines that are lightweight and compact to allow patients to travel with the device and use them at home. The newly partnered […]
NxStage Medical jumps on Q3 beat-and-raise, reveals pipeline
NxStage Medical (NSDQ:NXTM) shares started up today as investors reacted to beat-and-raise results for the home hemodialysis company’s 3rd-quarter and details about its development pipeline. Lawrence, Mass.-based NxStage said it narrowed its losses by -47.8% to -$1.7 million, or -3¢ per share, on sales growth of 14.9% to $86.5 million compared with Q3 2014. The […]
Baxter wins FDA nod for Amia dialysis device
Baxter (NYSE:BAX) said yesterday that it won 510(k) clearance from the FDA for its Amia automated peritoneal dialysis system, saying it plans to launch the device in the U.S. this year. The Amia device, which uses Deerfield Park, Ill.-based Baxter’s ShareSource web-based remote connection, is designed for home use by patients with end-stage renal disease. Baxter claimed […]