BrightWater Medical receives FDA clearance for convertible stent
The Food and Drug Administration recently gave market clearance to BrightWater Medical's ConvertX Nephroureteral Stent System.
The stent is intended to treat ureteral obstructions that prevent urine in the kidneys from draining into the bladder.
The device can convert from a catheter to a stent — first draining urine from the patient before acting as a stent to fix the blockage — eliminating clinician's need to perform two separate procedures.
“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," said Bob Smouse, MD, founder and CEO of Mountain View, Calif.-based BrightWater Medical.
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