BrightWater Medical, Inc., tells us three new studies demonstrate the feasibility of the ConvertX System in converting from an internal-external nephroureteral (NU) catheter into an internal NU stent without an invasive procedure.
More than 300,000 patients annually who are being treated for severe ureteral obstructions. The ConvertX System is a single device that replaces a series of two separate invasive procedures to treat severe obstructions of the ureters on an emergency basis. In the first of the two traditional one-hour procedures, the interventional radiologist (IR) implants a nephrostomy catheter to externally drain urine. Several days later, the externally implanted catheter is removed and a nephroureteral stent or “NU stent” is implanted to circumvent the blockage.
Once implanted, the ConvertX System converts from a nephroureteral catheter to a stent, eliminating the need for the second procedure. The conversion procedure is done externally in a physician’s office or bedside without the need for sedation or local anesthesia, in less than one minute. The ConvertX Stent remains implanted in the patient like a standard NU stent until the ureteral obstruction is resolved.
Three recently completed pre-clinical studies of BrightWater Medical’s innovative ConvertX™ Nephroureteral Stent System will be presented at the 2016 Society of Interventional Radiology (SIR) Annual Scientific Meeting (April 2-7, Vancouver, British Columbia, Canada).
In the studies, all conversions from the NU catheter into the NU stent were successful. During the study periods, no stent migration, blockage, encrustation, sedimentation, fracture or deformation were reported.
The ConvertX System is the only device designed to eliminate the need for a second invasive interventional procedure, by virtue of enabling the conversion in a brief office procedure. BrightWater says it will submit applications for the ConvertX System in the near future to the FDA for 510(k) clearance as a Class II device and for CE Marking in the European Union.
“By eliminating the need for a second invasive procedure, the ConvertX System may reduce risk, discomfort and inconvenience to the patient,” pointed out interventional radiology pioneer Barry Katzen, M.D., Founder and Chief Medical Executive of the Miami Cardiac & Vascular Institute. “It also 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 study results suggest the ConvertX System is a safe, less invasive, paradigm-changing device intended to enable interventional radiologists to improve patient care and reduce the time, costs and risks associated with conventional treatment of ureteral obstructions,” explained leading interventional radiologist Bob Smouse, M.D., founder and CEO of BrightWater Medical and Associate Professor of Radiology & Surgery at the University of Illinois College of Medicine.
Source: Business Wire