Medical Device Daily Senior
Parents and physicians no longer have to choose between long-term use of antibiotics or corrective surgery to treat vesicoureteral reflux (VUR), a condition of the urinary tract that predominantly affects infants and young children. Cook Medical (Bloomington, Indiana) this week released a new injection device intended to offer urologists greater control, precision and accuracy for treating VUR.
According to the company, the Injekt VUR injection needle marks an advancement in fast and minimally-invasive endoscopic treatment.
"Injekt enables a physician to treat pediatric patients with a minimally-invasive treatment option that ideally decrease the costs related to surgery or long-term treatment with antibiotics," said Nicky James, VP and global business leader for Cook's Urology division.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK; Bethesda, Maryland), urine normally flows in one direction – down from the kidneys, through tubes called ureters, to the bladder. VUR is the abnormal flow of urine from the bladder back into the ureters, NIDDK says. The organization notes that VUR is most commonly diagnosed in infancy and childhood after the patient has a urinary tract infection (UTI). About one-third of children with a UTI are found to have VUR, the NIDDK said. VUR can lead to infection because urine that remains in the child's urinary tract provides a place for bacteria to grow. But sometimes the infection itself is the cause of VUR, according to the organization.
VUR can cause swelling in the ureter and kidney, known as hydroureter and hydronephrosis.
The NIDDK also says there are two types of VUR. Primary VUR occurs when a child is born with an impaired valve where the ureter joins the bladder. This happens if the ureter did not grow long enough during the child's development in the womb. The valve does not close properly, so urine backs up (refluxes) from the bladder to the ureters, and eventually to the kidneys. This type of VUR can get better or disappear as the child gets older, according to the organization. The ureter gets longer as the child grows, and the function of the valve improves.
Secondary VUR occurs when there is a blockage anywhere in the urinary system. The blockage may be caused by an infection in the bladder that leads to swelling of the ureter. This also causes a reflux of urine to the kidneys.
Infection is the most common symptom of VUR. As the child gets older, other symptoms, such as bedwetting, high blood pressure, protein in the urine, and kidney failure, may appear, the NIDDK notes.
Cook says that previously, doctors had two options for VUR treatment: long-term use of antibiotics to prevent kidney damage caused by infections or invasive surgery to repair the defective valves. Increasingly, physicians are repairing faulty valves endoscopically, according to Cook. Using a scope threaded through the urethra, the physician injects a bulking agent around the leaking areas in the bladder wall called the ureteral orifices. Unlike surgical repair, injection therapy is an outpatient procedure that typically takes no more than 20 minutes and may result in correction rates up to 86%, the company said.
Cook says its Injekt VUR Injection Needle is the only injection needle designed specifically for VUR and can be used in either subureteric transurethral injection or hydrodistention implantation technique, the two most common methods used in the endoscopic treatment of VUR.
In introducing the Injekt, Cook notes several features intended to help physicians achieve and maintain precise needle position and depth relative to the ureteral orifice. Etch markings on the Injekt's filiform tip serve as landmarks to aid in precise placement of the bulking agent. The Injekt VUR Injection Needle's design allows for accurate placement of the bulking agent on the first injection, minimizing both the amount of time required for the procedure and the amount of bulking agent needed for effective treatment.
One of few treatment options for VUR, other than Cook's new Injekt device, is a product called Deflux from Q-Med (Uppsala, Sweden). Deflux is a gel that is used in endoscopic injections to treat VUR. It is the material that the surgeon injects around the ureter opening to create a valve function and stop urine from flowing back up the ureter, according to Q-Med.
Deflux is made of two types of sugar-based molecules (polysaccharides) called dextranomer and hyaluronic acid, Q-Med says. Both substances are well-known from previous uses in medicine, according to the company. Both materials are also biocompatible, which means they do not cause significant reactions within the body. In fact, hyaluronic acid is produced and found naturally within the body, Q-Med notes.
The gel forms a bump which keeps urine from flowing back into the ureter. Eventually, new tissue can grow around the gel and can provide long-term results for some children, according to the company. Q-Med says the success rate for Deflux is "high, but on average not as high as open surgery." Roughly 68% of VUR patients can expect to be cured with the gel, according to initial investigations. If the gel injections do not work, the child may require surgery, the company said.
Amanda Pedersen, 229-471-4212;