FDA clears BrightWater’s ConvertX Nephroureteral Stent System

1 December 2016 (Last Updated December 1st, 2016 18:30)

The US Food and Drug Administration (FDA) has granted clearance for BrightWater Medical's ConvertX Nephroureteral Stent System, which is used for treatment of ureteral obstructions.

The US Food and Drug Administration (FDA) has granted clearance for BrightWater Medical's ConvertX Nephroureteral Stent System, which is used for treatment of ureteral obstructions.

Patients with obstructions preventing urine in the kidneys from draining to the bladder face potential pain or infection, which requires immediate treatment.

In case of extreme pain or infection, they are referred to the interventional radiologist (IR).

"Interventional radiology enables patients with severe ureteral blockages to be quickly treated, and technologies like the ConvertX platform provide the IR with simpler, more cost-effective solutions."

ConvertX System enables the IR to eliminate a second invasive interventional procedure to treat the patient.

BrightWater Medical founder and CEO and ConvertX System developer Bob Smouse said: “Ureteral blockages due to kidney stones, tumours 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.”

In the two traditional procedures, where the IR first implants a nephrostomy catheter to externally drain urine and in the second procedure exchanges the nephrostomy catheter for an internal ureteral stent to circumvent the blockage.

On the contrary, the ConvertX System is implanted only once and converts from a catheter to a stent in a brief office procedure without the need for radiation or sedation, in less than one minute, and it remains implanted in the patient like a standard internal ureteral stent.

University of South Florida College of Medicine Clinical Associate Professor of Radiology James Benenati said: “The ConvertX System is the kind of technology advancement that we require to meet the dual goals of improving patient care and reducing the financial burden to the health care system.

“Interventional radiology enables patients with severe ureteral blockages to be quickly treated, and technologies like the ConvertX platform provide the IR with simpler, more cost-effective solutions.”