Simergent's Archimedes™ Home Dialysis System Receives FDA Clearance
Simergent has made headlines with their recent announcement regarding the Archimedes™ Home Dialysis System, which has officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This marks a significant milestone for the company and the patients they aim to help, particularly those suffering from End Stage Kidney Disease (ESKD).
The Archimedes™ system is notable for being an automated peritoneal dialysis (APD) device designed for both home and clinical use. The device allows for bloodless dialysis, which drastically improves the experience for patients who often face the burdensome requirements of traditional dialysis methods. Following a successful usability study in collaboration with Northwestern University and Indiana University, Simergent is set to launch this innovative system in the U.S. in 2026.
Dr. Jeffrey Perl, a respected nephrologist and Editor-in-Chief of the Peritoneal Dialysis International journal, praised the Archimedes™ system for its potential to transform kidney care. He emphasized that technologies like these can simplify processes for patients, ultimately enhancing their experiences with home dialysis therapies.
One of the key features of the Archimedes™ system is its user-centric design, which accommodates individuals from various educational and socioeconomic backgrounds. The system boasts a 4-hour battery life and is equipped with an integrated mobile cart, granting patients the freedom to perform their dialysis treatment in a comfortable environment. Additionally, its patented fluid delivery and measurement technology eliminates the need for a pump, making it a quieter option – particularly beneficial for those using it at night.
The device's innovative design also incorporates a patented shroud feature that ensures aseptic connection of tubing and bag systems, which is crucial for maintaining safety during treatment. Patients can set up the therapy in just five minutes, significantly reducing their waiting time and facilitating a more efficient experience.
Steve Lindo, CEO and co-founder of Simergent, expressed his belief that patients should have the autonomy to perform dialysis in the comfort of their own homes instead of being confined to clinics. The Archimedes™ system is built to provide that flexibility, allowing for normal everyday life while undergoing treatment. He noted that the device's intuitive user interface empowers clinicians as well by enabling them to offer more flexible treatment options, which is a necessity in today's healthcare environment.
In addition to improving the patient's experience, the Archimedes™ system also promises to change the dynamics for hospitals. The system's ease of use allows healthcare providers to treat patients employing their own nursing staff without overwhelming them with complicated procedures. The FDA clearance affirms Simergent's commitment to focusing on patient-centric kidney care, a mission that resonates strongly within the healthcare community.
Founded in Oklahoma City and Chicago, Simergent specializes in developing advanced medical technologies aimed at elevating the care standards for individuals battling kidney disease. Their flagship Archimedes™ automated peritoneal dialysis system aligns with their goal to empower patients with the ability to manage their own treatment schedules and environments, thereby enhancing their overall quality of life.
As the healthcare landscape continues to evolve, the Archimedes™ system sets a precedent for future innovations aimed at enhancing patient care. The overwhelming support from the renal community, demonstrated by a 98% appeal score in market assessments, indicates just how well the features of the Archimedes™ resonate with patients. With its user-friendly design and enhanced performance, the Archimedes™ Home Dialysis System is anticipated to make a significant impact when it enters the market in 2026.
The Archimedes™ system is notable for being an automated peritoneal dialysis (APD) device designed for both home and clinical use. The device allows for bloodless dialysis, which drastically improves the experience for patients who often face the burdensome requirements of traditional dialysis methods. Following a successful usability study in collaboration with Northwestern University and Indiana University, Simergent is set to launch this innovative system in the U.S. in 2026.
Dr. Jeffrey Perl, a respected nephrologist and Editor-in-Chief of the Peritoneal Dialysis International journal, praised the Archimedes™ system for its potential to transform kidney care. He emphasized that technologies like these can simplify processes for patients, ultimately enhancing their experiences with home dialysis therapies.
One of the key features of the Archimedes™ system is its user-centric design, which accommodates individuals from various educational and socioeconomic backgrounds. The system boasts a 4-hour battery life and is equipped with an integrated mobile cart, granting patients the freedom to perform their dialysis treatment in a comfortable environment. Additionally, its patented fluid delivery and measurement technology eliminates the need for a pump, making it a quieter option – particularly beneficial for those using it at night.
The device's innovative design also incorporates a patented shroud feature that ensures aseptic connection of tubing and bag systems, which is crucial for maintaining safety during treatment. Patients can set up the therapy in just five minutes, significantly reducing their waiting time and facilitating a more efficient experience.
Steve Lindo, CEO and co-founder of Simergent, expressed his belief that patients should have the autonomy to perform dialysis in the comfort of their own homes instead of being confined to clinics. The Archimedes™ system is built to provide that flexibility, allowing for normal everyday life while undergoing treatment. He noted that the device's intuitive user interface empowers clinicians as well by enabling them to offer more flexible treatment options, which is a necessity in today's healthcare environment.
In addition to improving the patient's experience, the Archimedes™ system also promises to change the dynamics for hospitals. The system's ease of use allows healthcare providers to treat patients employing their own nursing staff without overwhelming them with complicated procedures. The FDA clearance affirms Simergent's commitment to focusing on patient-centric kidney care, a mission that resonates strongly within the healthcare community.
Founded in Oklahoma City and Chicago, Simergent specializes in developing advanced medical technologies aimed at elevating the care standards for individuals battling kidney disease. Their flagship Archimedes™ automated peritoneal dialysis system aligns with their goal to empower patients with the ability to manage their own treatment schedules and environments, thereby enhancing their overall quality of life.
As the healthcare landscape continues to evolve, the Archimedes™ system sets a precedent for future innovations aimed at enhancing patient care. The overwhelming support from the renal community, demonstrated by a 98% appeal score in market assessments, indicates just how well the features of the Archimedes™ resonate with patients. With its user-friendly design and enhanced performance, the Archimedes™ Home Dialysis System is anticipated to make a significant impact when it enters the market in 2026.
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