Tablo® Hemodialysis System Receives FDA Clearance for Home Dialysis

Outset Medical has announced the Food and Drug Administration (FDA) cleared the Tablo® Hemodialysis System for patient use in the home. The new home clearance expands Tablo’s existing labeled indication for use in acute and chronic care facilities, which for the first time enables healthcare providers the same dialysis machine from the ICU to the home.

Tablo enters the market at a critical time in the midst of the COVID-19 pandemic and renewed national focus on home dialysis for improving patient outcomes while lowering cost.  In mid-2019, President Trump and United States Department of Health and Human Services Secretary Alex Azar announced an Executive Order to help Americans with kidney failure.  A major component of the policy was ensuring 80% of all new dialysis patients start therapy at home or get transplanted by 2025.  The emergence of COVID-19 further heightens the urgency for giving current in-center dialysis patients the option to treat at home.

“Tablo was designed to simplify dialysis, making it easier and more accessible for patients to take advantage of the safety, convenience and flexibility of dialyzing at home,” said Outset Medical Chief Executive Officer, Leslie Trigg.  “We are proud to offer them this new, life-enhancing option, particularly in light of the COVID-19 related challenges dialysis patients and providers are experiencing.”

Currently, more than 500,000 Americans undergo dialysis treatments three or more times each week, typically lasting four hours per treatment.  Approximately 100,000 new patients start treatment annually.  Yet only 12% receive it at home where they’re more comfortable, productive and empowered.

A prospective, multicenter, home hemodialysis trial with 30 patients was completed in 2019 and confirmed the Tablo system is safe and effective for home use.  The results were published in November 2019 in Hemodialysis International.

Troy Plumb, M.D., the principal study investigator and the Division Chief of Nephrology and Associate Professor of Medicine at the University of Nebraska Medical Center College of Medicine in Omaha, said, “My patients, colleagues and I are excited for Tablo to be available for home use.  The trial made it clear the system is easy to learn and performs well in the home environment.  I believe that Tablo will open up opportunities for patients to pursue home hemodialysis and take more control over their lives and care.”

One of those patients is 62-year-old Texas resident and technology consultant Richard Crawford.  He has had a kidney transplant that lasted 17 years and is currently on a transplant list.  Over the years, he has had thousands of dialysis treatments at various centers as well as on home hemodialysis.  He found using Tablo at home to be very intuitive, allowing him to dialyze while remaining productive during treatment.

“The home part of the Tablo trial only lasted eight weeks, but was eye-opening,” he said. “The system is extremely easy to set up and use, so I wasn’t wasting hours on dialysis-related tasks.  I was able to work at my desk during treatments, which was wonderful for my productivity.  The system provided me with a new level of independence due to the ease of setup and maintenance.  “When the trial ended and they had to pick up the Tablo, I tried talking them out of it.  I really hated seeing it go.”

Outset will begin a controlled rollout for home use at select sites over the coming months to ensure the highest level of training and support for Tablo home patients. This program will be balanced with the need to supply health systems, hospitals, and clinics with devices to support a surge of demand for dialysis treatments driven by COVID-19.  More information about availability for patients and providers can be found here

Tablo was designed in Silicon Valley to reduce the cost and complexity of dialysis care. Requiring only an electrical outlet and tap water to operate, the mobile Tablo system frees patients and providers from expensive clinic infrastructure.  The machine’s functionality enables it to serve as a dialysis clinic on wheels. Wireless data, sensor-based automation and an animated touchscreen make the system easy to learn and use.  Leading health systems and medical centers across the U.S. use Tablo for hospital and clinic dialysis, and the U.S. Department of Health and Human Services (HHS) awarded a contract for the use of Tablo in communities hit by natural disasters.

Hot this week

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.