Yet another aspect of imaging has been automated, eliminating human error, safety issues and increasing efficiency. Medrad (Warrendale, Pennsylvania) has received FDA 510(k) clearance for the first automated infusion delivery system for positron emission tomography (PET) and computed tomography (CT) imaging procedures using fluorodeoxyglucose (FDG).
"Our system's primary benefits are safety to the technologists in that it reduces their radiation exposure, precision of delivery and flexibility during PET/CT procedures," Alan Connor, director of global marketing for Medrad Molecular Imaging, told Medical Device Daily. "It's the first infusion system available in the U.S. to automate the FDG delivery process."
PET uses radioactive substances injected into patients to provide images of the body using specialized scanners. The images provide information about the function and metabolism of the body's organs. PET or PET/CT combinations are used mainly to study patients with cancer, heart disease and neuropsychiatric diseases.
The current process for administering an imaging agent involves manually measuring doses using ionization chamber in a hot lab. Then, patient-specific doses are manually delivered throughout the day as needed.
Medrad's FDG delivery process, called the Intego System, provides an integrated ionization chamber that automatically measures each dose just prior to administration.
Intego virtually eliminates manual dose preparation and handling, and the corresponding radiation exposure to the technologist.
The dose-on-demand system allows technologists to more readily respond to schedule changes, patient delays, and add-on patients. Other features include real-time dose availability information, an optional weight-based dose calculation, a tungsten multi-dose vial shield, a fully lead-lined mobile cart, and an automated saline flush to remove residual FDG from the line after each infusion.
"We've taken our competencies in other areas and applied them to a new area — PET imaging," Connor said. "It's an unmet need. Intego does require training on how to use the system. We have a team of 35 to 40 specialists to provide that training."
Connor said there are almost 2,000 PET scanners in the country performing 2.5 million procedures a year, with a high rate of growth projected in the next several years.
"Intego will create a new standard of care for PET imaging," he said.
The main Intego unit retails for $117,000. Disposables include a source administration set that's changed with each FDG vial at a cost of $75 and a patient administration set that costs $8.50 and is changed for each patient.
Connor said use of the Intego will be bundled with standard PET scanning reimbursement.
The company, which has developed and manufactured Intego entirely in-house, will provide its first commercial deliveries of Intego by Aug. 1.
Medrad is working with FDG suppliers to provide FDG in multi-dose vials and vial shields compatible with the Intego and recently reported a distribution and co-marketing agreement with the largest PET radiopharmacy network, Petnet Solutions, a subsidiary of Siemens Medical Solutions (Hoffman Estates, Illinois) (Medical Device Daily, June 16, 2008).
Medrad, a $500 million subsidiary of Bayer HealthCare (Leverkusen, Germany), earlier this year agreed to buy Possis Medical (Minneapolis) in a cash tender offer for $19.50 a share. The deal is valued at about $361 million (MDD, Feb. 12/March 27, 2008).