BrightWater Medical has announced that the US 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, the ConvertX is the only device that enables the interventional radiologist to eliminate a second invasive interventional procedure to treat the patient, a press release from the company says.
In the two traditional procedures, the interventional radiologist 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, tumours or scarring from previous surgeries must be treated quickly so urine can be voided,” explained ConvertX system developer Bob Smouse, founder and CEO of BrightWater Medical, and professor of Radiology and Surgery, 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 angiosuite for other procedures and save the interventional radiologist 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 healthcare system,” explained James F Benenati, 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 interventional radiologist with simpler, more cost-effective solutions.” Benenati is also medical director of the Peripheral Vascular Laboratory, 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.