BrightWater Medical has received approval from the US Food and Drug Administration (FDA) for its ConvertX nephroureteral stent system to treat ureteral obstructions.
Patients with obstructions preventing urine in the kidneys from draining to the bladder experience potential pain, infection, and long-term damage, requiring immediate treatment.
In severe cases, the Convert system allows interventional radiologist (IR) to avoid a second invasive interventional procedure to treat the patient.
The IR first implants a nephrostomy catheter to externally drain urine in the first traditional procedure, while the second procedure involves the exchange of nephrostomy catheter for an internal ureteral stent to circumvent the blockage.
In contrast, the ConvertX system is implanted only once and exchanges from a catheter to a stent in a brief office procedure without the need for radiation or sedation, in less than one minute.
Later, the Convert stent stays implanted in the patient like a standard internal ureteral stent.
BrightWater Medical founder and CEO Bob Smouse said: “Ureteral blockages due to kidney stones, tumors or scarring from previous surgeries must be treated quickly so urine can be voided.
“The ConvertX System saves the patient the risk and discomfort of an additional second interventional procedure and may reduce healthcare costs, free up the hospital’s angio suite for other procedures and save the IR procedural time that can be devoted to care of other patients.”
BrightWater recentlu secured its medical device manufacturing license from the California Department of Public Health, in addition to the FDA approval.
The firm is also submitting an application for the ConvertX system for the CE mark approval in the European Union, as well as developing additional ConvertX-based products for other staged procedure treatments in interventional radiology.