Most dialysis patients are presented with limited options for having a great quality of life. The quality diminishes further when they must consume 20-30 pills a day and have to put a harsh cap on their amount of fluid intake. Due to kidney dysfunction, they are in the hospital frequently, and must go to dialysis for 12 hours a week to get their blood filtered. It is safe to say that holding a job is tough for the average dialysis patient, and depression sometimes becomes a factor due to the multitude of restrictions put on his/her life. That’s where a new portable dialysis device comes in to play!
Victor Gura, MD, an internist and nephrologist from Los Angeles, has invented a portable dialysis device that is designed to improve the overall quality of life of dialysis patients. In place of a 300-pound dialysis device, the WAK is worn on a belt and provides the benefits of daily dialysis without compromising normal routines.
How does it work?
The WAK is battery operated, which is a unique alternative to the current machines that require constant access to an electrical outlet. It features a unique concept that regularly eliminates fluid to reduce kidney strain, while also controlling blood pressure. The invention has developed from weighing 11 lbs to only 2 lbs and is connected to the patient using a single catheter, inserted under local anesthetic. This allows the patient to perform a multitude of activities while having dialysis, which would not have been remotely possible with the traditional dialysis methods. The first clinical trial filtered the patients’ blood effectively, regardless of whether their diet included salty or phosphorus-rich foods, which would normally be avoided for dialysis patients.
The later iterations of the product involved having a day mode device and a night mode device. This facilitates the ability to have a smaller device that could be used during the day and a heavier one for the night that performs clinical tasks and recharges the battery.
The U.S. FDA reduced the number of clinical trials that they wanted from five to two after the first clinical trial performed successfully in 2015. Although there was increased risk for blood clotting with this device, the benefits on patients’ quality of life became crystal clear and outweighed the risk.
If you require assistance with applying for a Class II medical device licence, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.
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