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PROTOTYPE-----Nephrostomy Catheter is designed for use by pediatric urologists to obtain their own nephrostomy access during the kidney stone removal procedure. This technique for nephrostomy creation has an urologist advance a puncture wire through the working channel of a flexible ureteroscope and out of the kidney. Early data suggests dramatic reductions in radiation exposure, shorter learning curve, and less bleeding.
Percutaneous Nephrolithotomy (PCNL) is an inpatient procedure done on both children and adults to remove large, complex kidney stones. A passageway or channel (called a nephrostomy) is typically created by advancing a hollow-bore needle through the skin and into the kidney. This procedure is difficult to perform and is typically done by an interventional radiologist or a highly skilled urologist using fluoroscopy. Fluoroscopy exposes children and adolescents to imaging radiation during the procedure and should be minimized.
Atlantic Pediatric Device Consortium (APDC ) funding will be used to create a beta prototype and conduct performance and validation testing. APDC will advise and assist as this project finalizes engineering drawings, selects a manufacturing partner, and prepares for regulatory submission.
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