In an effort to make it easier for physicians to diagnose tubal occlusion, or blockage, a common condition in the fallopian tubes that can make it difficult to conceive, Cook Medical (Bloomington, Indiana) has reported the availability of the FluoroSet, a three-product radiographic tubal assessment set.

The set includes an intrauterine access balloon catheter, a selective salpingography catheter with Beacon Tip, and the Roadrunner PC wire guide with slip-coat hydrophilic coating.

According to Cook, nearly one million women in the U.S. are rendered infertile by disease in the fallopian tubes, the most common being tubal occlusion. This condition is commonly diagnosed using a complicated, invasive fluoroscopic evaluation, consisting of real-time, action images of the fallopian tubes to identify possible occlusions, the company said. Cook's new FluoroSet is intended to simplify this procedure and ease patient discomfort, Christina Anné, VP of Cook's Women's Health strategic business unit, told Medical Device Daily.

Anné said the set is not just about packaging products together. She said the idea came from the company's desire to help physicians diagnose tubal occlusion faster and easier. She said physicians in this specialty often have to go to three different places or have to look into a lot of different options to diagnose the condition.

"It's really a product we thought about to make it very assessable and very useful for the people who are involved in infertility diagnosis," Anné said.

According to Cook, the FluoroSet combines all the devices needed to introduce contrast media for fluoroscopic evaluation of both the uterine cavity and fallopian tubes, providing an optimal solution for the tubal occlusion diagnosis.

The intrauterine access balloon catheter is used for injection of contrast medium into the uterus and fallopian tube(s) for hysterosalpingography, the company noted. The catheter's unique design allows for easy cervical passage and the soft silicone balloon occludes the internal cervical OS. According to Cook, the catheter lumen allows for the introduction of catheters or other instruments up to 6.0 French in diameter into the uterine cavity, and the sidearm adapter on the Check-Flo Performer valve facilitates introduction of contrast medium and eliminates fluid reflux.

The second device in the set, the selective salpingography catheter with Beacon Tip, is used for injection of contrast medium into the fallopian tube(s) for selective salpingography and evaluation of tubal patency. Unique Torcon catheter material provides greater control of catheter manipulation and the Beacon Tip enables the device to be easily identified under fluoroscopy, according to the company.

The third device in the set, the Roadrunner PC wire guide with Slip-Coat hydrophilic coating, is an initial access wire guide used in cases demanding enhanced control and high radiopacity. Cook said the guide's Nitinol core construction provides rigidity and one-to-one torque control. Additionally, the device has Slip-Coat, a micro-thin layer of hydrophilic polymer that, that when activated, attracts and holds water and other liquids to the wire guide, creating a low-friction surface. According to Cook, the guide also boasts an olcott torque device to assist with wire guide manipulations.

"Tubal occlusion, or blockage, can have a severe impact on a woman's ability to conceive and it's extremely important that it is diagnosed quickly and accurately," Anné said. "With the FluoroSet, we are providing physicians with the tools they need to simplify the diagnostic process."

In addition to making the physician's job easier, Anné emphasized that the three-step process is "extremely comfortable" for patients.

Amanda Pedersen; 229-471-4212