Outset Medical CEO Leslie Trigg and the beginner’s mindset

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]

The home dialysis developer’s CEO discusses leadership, leaping before you look and making medtech for the home and hospital.

Eight years after becoming the CEO of Outset Medical (Nasdaq:OM) and two years after going public, Leslie Trigg says the medtech developer is finally at the starting gate for home dialysis.

It hasn’t been easy. The COVID-19 pandemic made it unsafe to train nurses in person, even as hospitals used the Tablo hemodialysis console in hallways and waiting rooms to clean patients’ blood. The pandemic also disrupted Outset’s supply chain. For example, it increased transportation costs for its single-use cartridges made by a contract manufacturer in Southeast Asia.

Last year, Outset had to put new shipments on hold while working through issues with the FDA.

And when she first go…

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Fresenius Medical Care designs quick-change dialysis filter

The Fresenius Medical Care Cartridge Express with Speedswap [Image courtesy of Fresenius Medical Care]

Fresenius Medical Care North America’s Renal Therapies Group has a new way to quickly change a flow-compromised dialysis filter without replacing the entire cartridge.

The dialysis provider and equipment manufacturer said today that its new Speedswap system is designed to address the common clogging or clotting of the dialysis circuit in continuous kidney replacement therapy (CKRT) in critical care settings. Speedswap is meant to shorten the time needed to change dialysis filters, reducing therapy downtime, easing nurse workloads and lowering treatment costs.

“This introduction of Speedswap aims to both improve the quality of dialysis treatment in the critical care setting and make our technology even easier to use by the care team,” Renal Therapies Group President Joe Turk said in a n…

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What Fresenius learned about COVID, kidneys and dialysis in the pandemic

Dr. Robert Kossmann is the chief medical officer for Fresenius Medical Care North America [Photo courtesy of Fresenius]

Dr. Robert Kossmann has a unique perspective of kidney care as the chief medical officer for Fresenius Medical Care North America and head of renal therapies for the company’s global medical office.

Germany-based Fresenius is the world’s largest provider of dialysis equipment and dialysis services, offering treatments at traditional dialysis centers as well as in patients’ homes.

Medical Design & Outsourcing recently spoke with Kossmann about kidney care in the pandemic, the challenges and benefits of home dialysis, logistics lessons learned and growth opportunities that medtech designers and engineers should keep in mind.

This conversation has been lightly edited for space and clarity.

MDO: What does COVID do to the kidneys during and after an infect…

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DOJ files fraud suit against Fresenius Medical division

Federal attorneys accused Fresenius Medical Care’s vascular care unit of performing unnecessary procedures on dialysis patients and billing the federal government.

U.S. Attorney for the Eastern District of New York Breon Peace made the allegations yesterday against Fresenius Vascular Care — doing business as Azura Vascular Care — as part of a whistleblower suit filed by two doctors in 2014.

Bad Homburg, Germany-based parent company Fresenius Medical Care said it disputes the allegations and intends to mount a vigorous defense.

“Our network of vascular centers is leading efforts to reduce total healthcare costs and improve patient outcomes by expanding access to innovative and less-invasive procedures,” the company said in a statement sent to Medical Design & Outsourcing. “Our policies are intended to result in a high standard of care and compliance with government regulations.”

Prosecutors said Azura Vascular Care…

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FDA warns of potential toxic risk from Fresenius hemodialysis machines

The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines.

The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K.

The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the silicone tubing used in the dialysate lines and the machine’s hydraulics.

“Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment,” the FDA said in a May 6 letter to health care providers.

The FDA said it has not received any related reports of adverse events, but said the chemicals in animals have been linked to endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.


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Fresenius Medical Care hires replacement for longtime CEO

Carla Kriwet will become CEO of Fresenius Medical Care [Photo courtesy of Fresenius]

Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO effective Jan. 1, 2023.

Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51.

“I fully identify with the vision of making the lives of the patients who have put their trust in us a little more worth living every day,” Kriwet said in a news release yesterday. “And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success.”

Fresenius CFO and CTO Helen Giza will assume the position of deputy CEO and enter into a new 5-year employment contract, the company said.

Kriwet served as CEO and president of BSH Hausgeräte (Home Appliances) GmbH from July 2020 until she stepped down for her ne…

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Laminate Medical lands FDA breakthrough nod for dialysis device

Laminate Medical Technologies today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis.

Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the transition of arterial flow to the vein while it reinforces the vessel wall against an increase in mechanical stress.

The company completed enrollment of a U.S. investigational device exemption pivotal trial in February. A total of 144 current and pre-dialysis patients referred for fistula creation were included in the study for either a brachiocephalic or radiocephalic fistulas with VasQ. Follow-up for the study’s primary endpoints are expected by August 2020 and will be evaluated by the FDA through the de novo pathway, according to Laminate Medical. The patients will be followed for two years.

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