‘Smaller, simpler, smarter’: Quanta officials review FDA-cleared portable dialysis system
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Already commercially available in the United Kingdom, the SC+ portable hemodialysis system from Quanta Dialysis Technologies has received 510(k) clearance “setting the stage for [a] U.S. market launch,” according to a press release.
The first treatments with the system were conducted in 2015 as part of a pilot study, with results demonstrating safety and efficacy.
To gain further insight into the device, Healio Nephrology spoke with John E. Milad, CEO of Quanta, and Paul Komenda, MD, FRCPC, MHA, chief medical officer for the company and the primary investigator on a study published in 2020 evaluating self-care with the system.
“We wanted to simplify a complex therapy to make it accessible to a broader range of users,” Milad said of the vision for the system. “We wanted to make it possible to bring dialysis to the patient, so we developed something that is portable and compact. We also wanted to provide the standard of care as delivered by bigger complex machines, thereby allowing for maximum clinical flexibility. With SC+, we have created a device that is smaller, simpler and smarter. Combining these attributes into one system is a true breakthrough.”
Question: What are some of the key differences between the SC+ Hemodialysis System and other hemodialysis machines on the market? How can it improve care and patient outcomes?
Paul Komenda: The device that we have launched, which now has 510(k) clearance for facility-based use, can be described as small, simple and powerful.
It is a tabletop device that looks sort of like one of the older Apple computers. It can either sit on a tabletop or on the proprietary watercart we have developed, depending on what the situation calls for. I think it is important to stress that our device is small and decoupled from the water system. If something goes wrong with the device, we can troubleshoot it within the cloud or get a new device to the user in a short period of time. That is not a possibility for many devices on the market because they require a service technician to fix on site. We think that this is a key advantage as the machines get disseminated out of traditional dialysis units.
The device is also simple to use. We were able to train health care practitioners to confidently use the device after just a couple of training sessions. We recently saw this when we rolled out SC+ in intensive care units across the United Kingdom to support ICU nephrology in the context of the COVID-19 pandemic. There was an overwhelming demand for machines and we were able to train 60 nurses in one hospital in a couple weeks (and they were ICU nurses not traditionally trained to administer dialysis treatments). Based on the human factors testing we have published, as well as this evidence from the real world, we are confident in the simplicity of the device. It implements a new school of contemporary user interface, step-by-step instructions that walk a user through how to set up the machine, as well as on-screen troubleshooting for any errors that might occur.
Thirdly, SC+ is powerful. Some of the other contemporary devices on the market that have been around for a few years do not deliver the same performance as our traditional in-center devices, which boils down to how fast we can run the dialysate across the blood to clean it; our device delivers up to 500 mL/minute dialysate flow rate, which reflects the standard of care. Because we offer the same performance as a traditional in-center device, patients will likely only need to dialyze three times per week, although we acknowledge the advantage of more frequent dialysis in many cases.
Q: What types of patients do you anticipate using the machine?
PK: Initially, we are not intending to go after the bulk of the three times per week facility-based market in the United States; we are attempting to go for a couple of specific use cases. Number one being the acute hospital-based market. Whether in the emergency room or on a ward, we can deliver the same standard-of-care as the larger machines that are more challenging to use and to move around.
The second use case that we are considering at this point is the skilled nursing facility market. This is especially timely right now as we have a situation where residents — often frail, elderly patients — are at high risk for contracting COVID-19 and suffering adverse outcomes. With our device, we can the dialyze these vulnerable patients without requiring them to be transported to a center which we think will lead to cost savings, offer better care and reduce their exposure risk.
Q: Can you talk a little about the study assessing the device that was published in Kidney Medicine in October 2020?
PK: This was a real-world observational study design of prevalent hemodialysis patients in the United Kingdom. Most of them were on facility-based dialysis three times a week, while others were on self-care dialysis performing their own treatments. We wanted to show that we were able to deliver the standard-of-care (as measured by Kt/V) in multiple centers across a diverse group of patients, and we demonstrated that. We also wanted to make sure that the device is safe in the field. We can run things in the lab and everything looks great but, when we get out into the real world, effectiveness and safety of the device are critically important. We found no device-related adverse events. These findings gave us a lot of confidence for our commercial launch in the United States. If I am a nephrologist who has not seen this type of larger observational real-world effectiveness study, I might be a little bit more nervous wondering if the device was tested in the field. So, the intent of the study was to show that yes, we have; yes, it is reliable; and yes, it is safe, all while achieving the clearances we said we were going to achieve.
Q: What will your process be for monitoring patient outcomes once the device is in use?
PK: Quanta has a robust quality management system in terms of tracking and logging customer complaints and issues through a formalized process. We are confident that we can effectively respond to these issues, especially having some commercial validation in the United Kingdom to refine the process.
Secondly, the device itself is embedded with multiple sensors and a modem that can transmit data (related to machine functioning and device performance) into our cloud-based service portal where we can quantitatively analyze issues with the machine proactively before we even see machine failures.
Thirdly, we will be launching a patient-based portal that logs information and clinical data (such as weight before and after dialysis and blood pressure), but also uniquely reports patient-reported experience measures. This tracks how the patients are feeling and what their experiences are with the device.
So again, there are multiple layers we are considering to determine the real-world effectiveness of our device. In 2021, we are in a unique spot in terms of technology. We can collect a lot of data electronically; this was not possible when some of the older devices were designed.
JM: Like with all medical devices, we need to have surveillance. If there are any problems, we track them. We have a digital health tool that allows us to get a more complete picture on how the device is performing and how users are experiencing it in the real world. And we also conduct formal studies, like the study published in Kidney Medicine, that thoroughly evaluate the device.
We are very much an evidence-based scientifically driven company. Our objective has always been to deliver something different in the world of dialysis, while holding the bar up to demonstrate that our products come with solid evidence. This is important to our mission and how we operate.
Q: When will the SC+ be available for use in the United States?
JM: First, I wanted to clarify the way we think about our product: We believe it enables more flexibility in how dialysis can be delivered, for which there is a strong need. We are initially going to start with facility-based dialysis and then, we will do some more work to get the home label.
In terms of timing, we are hoping to get it all wrapped up by 2022. With respect to our launch in the United States, we are in discussions with potential customers. We still have got a lot to do though. We want to make sure that when we launch this, we are doing it in a robust way and that our customers and users have an excellent experience.
We hope to make the SC+ commercially available in the spring of this year.
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