This article is part of Reacheda series about companies that are harnessing new science and technology to solve problems in their industries.
Paul Hall was thinking of his swimming pool. In his mind, he was far from the nondescript clinic in Orange, California, where he sat quietly, his blood flowing through a hemodialysis machine, ridding it of toxins. Soon he would see his three grandchildren splashing about while doing his treatment. Or watch TV. And he would do all of this at any time.
“There is no place like home,” said Mr Hall, 64.
He only had a few sessions left to train in the use of the Tablo hemodialysis system, a home dialysis product made by San Jose-based Outset Medical. When he was done, he hoped to hook it up at his home in the Moreno Valley.
The size of a college dorm refrigerator, this generation’s hemodialysis machines look nothing like the hulking machines first introduced to the home market in the 1960s. A touchscreen, which uses 3D animation to guiding users through each step, is mounted on a box with a built-in water purification system.
After a 30-minute setup process, which included inserting two 14-gauge needles into his left arm, the machine congratulated him, “Good job, Paul!”
Like most of the 780,000 Americans with end-stage kidney disease, Mr. Hall needs dialysis or a transplant to live. The number of people with chronic kidney disease in this country is expected to only increase. It already affects about one in seven adults, according to the United States Renal Data System’s 2022 annual report.
A transplant would not be Mr. Hall’s first; that of his eldest son about two decades ago is failing. Without functioning kidneys, additional liquid and toxic waste can build up and poison the body. Each year, about one in six patients on maintenance dialysis dies, according to the USRDS. Others forgo treatment, likely due to other life-limiting conditions, such as advanced cancer or heart failure.
“Patient outcomes are certainly better, but they’re still unacceptable,” said Dr. Joseph Vassalotti, chief medical officer of the National Kidney Foundation.
The company that would become Outset Medical started in 2010; it was launched commercially in 2018, when Tablo entered hospitals and clinics. The Food and Drug Administration cleared Tablo for home use in March 2020, just as vulnerable populations were required to self-isolate due to the coronavirus pandemic. Later that year, the company went public in a virtual IPO.
The only current alternative to home hemodialysis systems is the portable NxStage System One, manufactured by Fresenius Medical Care, headquartered in Germany. It was introduced to homes in 2005, with a newer version, VersiHD, following more recently.
Among the hemodialysis units examined in a market analysis, Tablo is the most expensive hemodialysis unit on the market, according to market research by ECRI, a non-profit patient safety organization certified by the federal government. Tablo costs an average price of $47,000, excluding service or operating costs, compared to $26,000 for the NxStage System One.
Dialysis is indeed expensive. The Centers for Medicare & Medicaid Services hope to reduce expenses and improve the quality of care for their beneficiaries with end-stage kidney disease. Through financial incentives to dialysis providers, physicians, health systems, and kidney transplant programs, the agency seeks to increase home dialysis, as well as kidney donation.
The obvious need for home systems is another factor. The majority of dialysis patients go to clinics for hemodialysis, with little flexibility for long distances, snowstorms or car problems. Patients often rate themselves as having a poor quality of life, as cramps, insomnia, depression, and anxiety are common.
Mr. Hall missed so many life events, he said. And while he’s not complaining, when clinics close for long holiday weekends, he notices a difference.
“I can say how I feel after two days,” Mr Hall said. “If it starts to get harder to breathe in and I know there’s fluid in my lungs, I want to get rid of it.”
Home dialysis is not a new idea, said Leslie Trigg, chief executive of Outset Medical. In the early 1970s, it was estimated that more than 30% of dialysis patients did their treatment at home. Often they had little choice, with dialysis units unable to keep up with demand, according to a 2017 review in the journal Seminars in Dialysis.
In 1972, this changed with the expansion of Medicare, which included coverage for people with end-stage kidney disease requiring dialysis or a kidney transplant; in turn, this coverage funding has enabled the growth of outpatient dialysis clinics. In the half-century since, the population of dialysis patients has grown, as has for-profit center dialysis.
Today, about 14 percent of dialysis patients are treated at home, alone or with a care partner, and that number is growing, according to the USRDS. It is estimated that 2% are on home hemodialysis. Most perform peritoneal dialysis, which involves infusing dialysis solution into the lining of the abdomen to filter out waste products from the body. It is usually prescribed daily and for much longer periods each day than hemodialysis.
Mr. Hall tried that too for two years. He preferred the peritoneum and wishes he could return to it now, but developed an infection.
Training is required for all home dialysis candidates and the person assisting them, and the home health company or agency usually visits the home during the initial period.
But even with these measures in place, there are other considerations.
“It’s not for everyone,” said Dr. Mark Sarnak, chief of the division of nephrology at Tufts Medical Center. “Some people have needle phobia, some people may not have the eyesight to do peritoneal dialysis, some people may be too sick.”
And not all are comfortable with technology, have the support of family members (if needed), or the extra space to store supplies or the machine. Others prefer to have a trained professional oversee the treatment.
For Mr Hall to do his three-hour Tablo treatment, he connects a needle to an arterial line to move blood through the machine’s dialyzer, also known as an artificial kidney. He attaches the other to the venous line, through which his cleansed blood returns. The hardest part for him, however, is the end of the treatment, when he has to remove the needles and apply just the right pressure to prevent major blood loss. His ex-wife and daughter have been trained on how to help.
Easy access to home dialysis has advantages. Traditionally, in a clinic, a large amount of fluid is removed in a short time and many patients feel exhausted afterwards. With peritoneal dialysis and more frequent hemodialysis, “it’s a lot smoother,” said Dr. Sarnak, lead author of a recent statement from the American Heart Association. There are also potential cardiovascular benefits with more frequent hemodialysis, according to the release.
(The risk of infection, however, may increase with higher frequency. And although rare, infection is also a risk for patients on peritoneal dialysis.)
The FDA requires a care partner when using Tablo – another potential hurdle for patients wishing to transition to home use; the clinic supervising the patient at home confirms the availability of one, according to Outset Medical. (NxStage System One is allowed to operate alone, but if patients use it at night while sleeping, a care partner is encouraged.)
Another problem is that home dialysis has not reached all populations in need. Black and Hispanic patients, disproportionately affected by kidney disease, are less likely to start home dialysis than white patients, USRDS says
More options may be on the horizon. One from Quanta Dialysis Technologies, already licensed for chronic and acute environments, is in clinical trials for the home. Another, from CVS and Deka Research & Development Corp., is in the final stages of a clinical study.
At the start of this year, 2,300 Outset systems were in use in hospitals, rehabilitation centers and long-term care facilities. But the company’s home rollout has been slow, with around 300 devices being used by patients at home or in training locations, according to the company’s latest public figures.
The Tablo research is promising, doctors say, but limited due to its small sample size and relatively short-term follow-up. Dr. Michael Aragon, a nephrologist based in Fort Worth, Texas, helped oversee Tablo’s home-based safety and efficacy trial before joining the company as chief medical officer. The trial found that 28 end-stage renal disease patients who completed the study had adequate toxin elimination on Tablo, and the device was found to be safe both at home and in the clinic.
During Mr. Hall’s trial treatment at the clinic, he also had to learn how to troubleshoot. Two hours later, as the leaves of a tree on the machine gradually turned green to indicate the time remaining, an alarm sounded. The machine had tried to take his blood pressure but had failed. A nurse repositioned the cuff. (Although rare, fainting from low blood pressure is a risk at home or at the clinic.)
Several reports of bleeding, loss of consciousness, and death associated with Tablo have been reported to the FDA’s adverse event database over the past four years. Ms Trigg said none of the adverse events affecting patients were deemed by the company to be related to Tablo.
NxStage System One also has its own share of similar adverse events, although a Fresenius Medical Care spokesperson said no injuries or fatalities were deemed to be the fault of the machine’s equipment.
Ismael Cordero, senior project manager for device assessments at ECRI, the security organization, reviewed the reports from both companies. Any potential harm, he said, becomes “even more of a concern when the devices are used outside of a clinical setting”.
Carly Kempler, spokesperson for the FDA, said the database had limitations and that “if the FDA becomes aware of information that indicates a safety issue with a medical device, the FDA will take appropriate action.”
Mr. Hall hopes to receive another transplant. In the meantime, he is finally taking care of himself at home, with the help of his family. Although the first Tablo he received had problems, his replacement works well.
No longer going to the clinic, he is happy with the choices each day has in store for him – simple choices like treatment early in the morning or in the evening? “It’s a great feeling to know that I can work around anything that comes my way,” he said.
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