A Medical Device Daily

E-Z-EM (Lake Success, New York) has launched a new point-of-care device for conducting blood assays in patients who are scheduled to undergo computed tomography (CT) or MRI scans to test kidney function, specifically levels of creatinine, prior to the exam.

The assay, called EZ CHEM — providing results in “as little as 30 seconds, ”according to the company — is designed to provide information on creatinine levels to a physician, who must still make the decision as to whether it is safe to proceed.

E-Z-EM said it is important to check these levels, as there can be adverse reactions to contrast agents.

“It’s really a productivity tool,” Jennifer Hwang, marketing manager, injector systems, for E-Z-EM, told Medical Device Daily. “It’s going to help a lot of busy CT or MRI departments, as they certainly have issues with getting creatinine results. The situation right now is that a lot of places are waiting anywhere from 45 minutes to up to three hours for creatinine results from a lab.”

The risk to the imaging center — whether that is a hospital or free-standing diagnostic imaging center — is that the length of time required to wait can result in a patient being required to reschedule a scan, or the hospital or diagnostic imaging clinic losing that patient to another center, Hwang said.

“A lot of these CT departments have 10 or 15 of these CT scans booked for the entire day, and if any of these patients come in without their creatinine results, then a lot of these places either have to reschedule them or actually lose that patient altogether,” she said.

The key to the productivity claim is that the test system — which looks very much like a typically-sized glucose monitor — can be used in the imaging suite. It requires a finger prick for a blood sample.

Hwang noted that there is a danger of contrast-induced nephropathy, or kidney disease, “which is associated with the contrast media used in CT.”

According to statistics provided by Hwang, there were about 62 million CT procedures in 2006, and 59% of those, or 36.4 million procedures, require contrast media. Likewise, there were 26.6 million MRI procedures in 2006, and 45% of those require contrast, or 12.1 million.

“Of those procedures, we’re estimating anywhere from 10% to 20% of those procedures where a physician would use an EZ CHEM,” Hwang said.

There have been instances in the media recently, Hwang noted, publicizing the danger of contrast agents, particularly in individuals who have a pre-existing condition such as diabetes, hypertension or kidney disease.

Brad Schreck, the company’s senior VP of global sales, marketing and engineering, in a statement, said, “EZ CHEM provides the ability to quickly and accurately assess kidney function where it is needed most, at the point-of-care. Screening for patients with renal insufficiency has been in focus recently, as certain contrast agents, particularly those used with MRI, have been associated with Nephrogenetic Systemic Fibrosis, a debilitating and potentially severe condition that currently has no clear and widely successful treatment.”

Schreck went on to say that the company believes that the EZ CHEM will “reduce the risks associated with the use of IV contrast” agents for “certain patients.”

For example, Hwang said that with CT scans, the instances of contrast-induced nephropathy could be anywhere from 5% to 38%, depending in part on whether a patient had pre-existing risk factors.

E-Z-EM’s development partner for EZ CHEM, Nova Biomedical (Waltham, Massachusetts), submitted a FDA 510(k) application for the basid technology under that company’s name for the device, StatSensor, in January and received the marketing clearance in May.

E-Z-EM said that Nova has since completed “all remaining regulatory and engineering requirements” for EZ CHEM.

Although there are competitors already operating in this arena, Hwang said that the number of CT and MRI procedures is “expected to get much larger.”

E-Z-EM will be targeting its marketing and sales efforts to radiology departments, gastroenterology departments in hospitals or outpatient clinics, as well as independent imaging centers.

Among the contrast agents for gastrointestinal radiology made by E-Z-EM makes is VoLumen, a low-density barium sulfate suspension for use as an oral contrast in multidetector CT and positron emission tomography. The company also offers Empower, a family of CT injectors, as well as injectors for MRIs.

“Most of our revenues really come from barium products, whereas the biggest growth really comes from the equipment side of the business,” Hwang said. “We also have products in virtual colonoscopy, and all of those products are certainly going to contribute to our growth.”