FDA Clears BrightWater Medical’s ConvertX Nephroureteral Stent System

BrightWater Medical Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s innovative ConvertX Nephroureteral Stent System for treatment of ureteral obstructions. Patients with obstructions preventing urine in the kidneys from draining to the bladder face potential pain, infection, and long-term damage, necessitating immediate treatment. In severe cases referred to the interventional radiologist (IR), the ConvertX System is the only device that enables the IR to eliminate a second invasive interventional procedure to treat the patient.
 
In the two traditional procedures, 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. The ConvertX System, in contrast, 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. The ConvertX Stent then remains implanted in the patient like a standard internal ureteral stent.
 
“Ureteral blockages due to kidney stones, tumors or scarring from previous surgeries must be treated quickly so urine can be voided,” explained ConvertX System developer Bob Smouse, M.D., founder and CEO of BrightWater Medical and Professor of Radiology & Surgery at the University of Illinois College of Medicine. “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.”
 
“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,” explained James F. Benenati, MD, FSIR, Clinical Associate Professor of Radiology at the University of South Florida College of Medicine. “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.” Dr. Benenati is also Medical Director of the Peripheral Vascular Laboratory at the Miami Cardiac & Vascular Institute and Past President of the Society of Interventional Radiology.
 
In addition to the FDA clearance, BrightWater recently received its medical device manufacturing license from the California Department of Public Health. The company is submitting an application for the ConvertX System to the European Union for CE Marking and is developing additional ConvertX-based products for other staged procedure treatments in interventional radiology.