In the land of television, high-definition means a better quality image compared to standard television. In the world of endoscopic ultrasound (EUS) needle technology, high-definition means more accurate images of the gastrointestinal (GI) tract than traditional ultrasound and minimally invasive access to areas that are traditionally difficult to reach, according to Cook Medical (Bloomington, Indiana).
This week Cook launched a line of high-definition EUS biopsy needles that it says are up to three times brighter than others on the market. With the addition of the 19 and 25 gage EchoTip Ultra with High Definition Fine Needle Aspiration (HDFNA) needles, the EchoTip Ultra HDFNA represents the next level of precision in EUS, according to the company.
"This needle is very high contrast and easy to see within targeted lesions," said John DeWitt, MD, Indiana University-Purdue University (Indianapolis). "This permits confidence for the endosonographers that the lesion is being accurately targeted."
Ultrasound in GI is different from ultrasound in a lot of other areas in that most of the time ultrasound is used externally as a way to see inside the body for clinicians to get access to the anatomy from the outside, Barry Slowey, VP of global sales and marketing for the Endoscopy unit at Cook, told Medical Device Daily. During a EUS procedure, however, the technology allows the physician to see the patient's body from the inside of the GI tract outwards, he said.
During a EUS procedure, the endosonographer inserts an endoscope, which has a small ultrasound transducer at its tip, through the patient's mouth into the esophagus, facilitating imaging from within the GI tract. EUS also enables tissue sampling through fine needle aspiration (FNA), a safer and less invasive alternative to open surgical biopsy. Under ultrasound guidance, a special needle inserted in the endoscope collects cells from targeted sites.
Cook's EchoTip Ultra with HDFNA is a single-use, disposable needle intended for sampling of targeted submucosal GI lesions through the accessory channel of an ultrasound endoscope. According to the company, the needle surface is dimpled with a high-definition pattern that greatly improves its visibility on an ultrasound monitor. This highly echogenic design provides increased assurance that the needle tip is within the target, Cook said.
With traditional EUS-guided FNA, the endosonographer usually has to pass the needle multiple times into the lesion in order to get an accurate sample, Slowey said. With the enhanced visibility of EchoTip Ultra HDFNA needles, specimens can be obtained with potentially fewer needle sticks.
Also, Cook said, the new device has all the advantages of the original EchoTip Ultra products, with an integrated sheath adjuster that makes the needles compatible with a full range of echoendoscopes and an ergonomically designed handle integrated with a nitinol stylet for precise needle control, stability and flexibility. The safety lock ring easily slides and locks at the desired needle extension and a "Zero" reference mark indicates the needle's complete retraction within the sheath. In addition, EchoTip Ultra's metal Luer lock provides a secure, stable platform for performing EUS procedures, according to the company.
Slowey told MDD that in the early days of endoscopy a gastroenterologist could see inside the GI tract to diagnose a problem, but they couldn't do much to treat it. Since then, the field has branched out into several therapeutic procedures, he said.
"EUS is sort of at the same stage as endoscopy was about 20 years ago. In other words, when people came along with this new technology ... for quite a number of years all anybody did was diagnose, you could look down and see organs and that was a really exciting first step of that procedure," Slowey said. Then, companies like Cook developed EUS fine needle aspiration needles, which allowed physicians to start doing therapeutic procedures.
Slowey said the EUS market is about a $35 million market and Cook has about 85% of the market share.
"Cook is the proven leader in the nearly 20-year-old EUS market, offering the most advanced and widest variety of exclusive endoscopic devices," Slowey said. "We believe the improved visibility experienced with the EchoTip Ultra with HDFNA represents the next generation of EUS devices."