Product innovation continues with new Endoscopy wire and needle

Like our colleagues across Cook Medical, the Endoscopy team in Winston-Salem is also navigating the challenges of remediation and ongoing improvements to our quality systems. Yes, these measures are challenging, but they are the path toward making us the best company we can be—a goal that aligns with our overall mission to always put the patients and customers first. At the same time, we must continue to fulfill another important part of our mission: To develop innovative medical devices that our customers around the world can use to treat their patients.

We are happy to report that recently we’ve been able to launch several new products, including the Acrobat® 2 Calibrated Tip Wire Guide and the EchoTip® Ultra Fiducial Needle. Both devices made a huge splash in May at Digestive Disease Week (DDW), our biggest trade show of the year.

In developing the Acrobat 2 wire, our goal was to create a “go-to,” everyday wire guide for gastrointestinal (GI) endoscopists performing endoscopic retrograde cholangiopancreatography (ERCP), a technique that uses fluoroscopy to view the patient’s bile and pancreatic ducts (called the pancreatobiliary system).

Acrobat 2 wire blends two qualities requested by physicians

The most common reason why a patient needs an ERCP is to diagnose and potentially treat abnormalities in those ducts, such as blockages, irregularity in the tissue, problems with the flow of bile or pancreatic fluid, or stones or tumors.

Being able to access and navigate the pancreatobiliary system is key to all ERCP procedures. Wire guides are often used for initial access and to navigate the ducts. Then they can be used to introduce therapeutic instruments, such as a cutting device, a catheter, a stent, or a dilation balloon.

“We began the Acrobat 2 development process by asking hundreds of doctors and nurses around the world what they wanted in a wire guide,” said John Curran, product manager. “What we heard over and over again was their desire for a wire that delivered consistent, exceptional performance in the wide variety of situations they encounter every day.”

The Acrobat 2 development team identified two key wire guide features to meet that criteria: tip flexibility and wire pushability. “We knew that those two characteristics would help with access and navigation,” said Roya Nezarati, research and development engineer. “So, we set out to create the ideal blend of flexibility and pushability, using a strong body and a very flexible tip.”

The Acrobat 2 Calibrated Tip Wire Guide is used to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP. The product is currently cleared for sale in North America and Europe. Other global region launches are planned for the future. 

EchoTip Ultra Fiducial Needle offers first preloaded option

The recently launched EchoTip Ultra Fiducial Needle was the first device on the market to allow endoscopic ultrasound (EUS) specialists to place up to four preloaded fiducial markers in one procedure. Fiducials are small radiographic metal objects that are used to mark the anatomical location of tumors for future radiation intervention.

Prior to this new device, the only way to place multiple fiducials by EUS was to manually load them one at a time into an EUS needle, then remove the needle from the endoscope each time to reload before the next marker could be placed.

“Collaborating with both endoscopists and radiation oncologists, our goal was to create a device that bridges both specialty areas,” said Kevin Chmura, senior product manager. “The result is a device that can be more efficient for endoscopists who need to place two to four fiducial markers to help radiation oncologists more accurately target tumors.”

During the engineering phase, the team investigated and tested different concepts for a preloaded needle. The most promising idea involved the use of customized fiducials that could be individually advanced, thanks to a novel slot design at the distal tip of the needle.

“Endoscopists and oncologists alike were instrumental in helping us create a device that is a versatile tool for a breadth of clinical scenarios,” said Michael Brecht, research and development engineer. “That’s what I love about our work. It’s exciting just how many different people, departments, clinicians and, ultimately, perspectives it takes to create a successful product!”

The animation below shows the fiducial needle in action.

The EchoTip Ultra Fiducial Needle is used to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The product is cleared for sale in North America and limited markets throughout EMEA and APAC.