Medical Device Daily
Cook Medical (Spencer, Indiana) yesterday reported the availability of what it calls a first-of-its-kind Goldstein SonoBiopsy Catheter for use in diagnosing the cause of abnormal uterine bleeding.
Neal Bridgett, director of business development for Cook Women’s Health, a division of Cook Medical, told Medical Device Daily that the Goldstein SonoBiopsy Catheter is unique because it combines Saline Infusion Sonohysterography (SIS) and biopsy functionality in a single device, thus qualifying as a two-in-one technology.
The device provides physicians with the increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to biopsy endometrial tissue during the same procedure, the company said. In addition, it said the Goldstein SonoBiopsy Catheter eliminates the need to introduce additional instruments into the patient’s body and therefore reduces the incidence for multiple procedures.
“Saline infusion Sonohysterography has really become an additional standard of care ... the Goldstein SonoBiopsy Catheter really combines these two very critical aspects of looking at this condition,” Bridgett said.
According to Cook, abnormal uterine bleeding affects 10 million women in the U.S. and accounts for roughly one-third of all visits to the gynecologist. In the most severe cases, abnormal uterine bleeding can be a sign of endometrial cancer, leukemia or a coagulation disorder. It can also result in anemia if not treated quickly and effectively.
Even less severe cases may dramatically affect a woman’s daily activities and can have a negative affect on overall quality of life, the company noted.
The Goldstein SonoBiopsy Catheter allows physicians to fill the uterus with saline solution, enabling better echo-resonance of the uterine cavity during an ultrasound. The catheter’s acorn-shaped stopper is designed to keep the fluid inside the uterus and prevents it from draining, allowing superior uterine imaging during the procedure. If the physician determines that an endometrial biopsy is required, the Goldstein SonoBiopsy Catheter also allows the physician to apply suction to the catheter to aspirate an appropriate tissue sample for evaluation. The diagnostic procedure is completed during one patient visit.
Bridgett said that in several clinical evaluations of the device during its development, the sampling that occurred with the Goldstein SonoBiopsy Catheter was as good as or better, than current methods. He also said that the device significantly reduces procedure time and increases comfort for the patient because the doctor does not have to re-insert the speculum and place in a different catheter to perform the biopsy.
Ted Cox, MD, presented his recent experiences with the Goldstein Sonobiopsy Catheter at the 2007 annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington) in San Diego. He said that the Goldstein SonoBiopsy Catheter reduced procedure time by 30% when compared to other devices.
“With the Goldstein SonoBiopsy Catheter, Cook Medical has taken the next steps in the continued improvement of the work-up and triage of abnormal uterine bleeding. The Goldstein SonoBiopsy Catheter has significantly reduced procedure times and patient discomfort while still producing an excellent sonohysterogram and providing an accurate endometrial biopsy all in the same catheter,” Cox said.
“Given the nature of abnormal uterine bleeding, diagnosis often requires many invasive tests that can be uncomfortable and extremely time consuming for patients,” said Christina Ann , global leader of Cook Women’s Health. “With the Goldstein SonoBiopsy Catheter, we’ve reduced patient discomfort by combining two of the most common tests into one device, thus reducing the need for multiple procedures.”
Cook launched its Women’s Health business unit in May of last year (Medical Device Daily , May 9, 2006), and the unit grew 30% in its first year (MDD, May 11, 2007). The unit addresses various areas of women’s health issues, including pelvic floor repair, high-risk obstetrics, assisted reproductive technology and gynecological imaging.
Cook says it was the first company to introduce interventional devices in the U.S. The company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech.