SMV wins FDA clearance for Positrace hybrid PET/CT camera

Sep 3, 2000

Nuclear medicine specialists in the U.S. now have access to another tool with which to explore hybrid PET/CT imaging after camera vendor SMV received clearance to market its Positrace scanner. The Twinsburg, OH, company believes that Positrace is the first commercially available system that combines a dedicated PET camera with a fully diagnostic CT scanner.

SMV received clearance for the product on August 25, according to Lonnie Mixon, vice president of worldwide marketing. The company's timing is fortuitous, coming just before the opening of this week's European Association of Nuclear Medicine (EANM) meeting in Paris. SMV is highlighting Positrace in its EANM booth, with particular emphasis on clinical images collected with the system at the Positrace beta site in Rennes, France.

"We'll be showing various cancer conditions, and emphasizing studies where the CT scanner made a definitive difference," Mixon said. "We think that further research will confirm that a clinician that has the CT data available has much more power diagnostically than a clinician utilizing PET alone."

SMV's goal is to offer an affordable system that enables clinicians to explore hybrid imaging with fully diagnostic PET and CT components. Interest in hybrid scanning has been on the rise as clinicians look for ways to visualize both functional and anatomic processes. Siemens Medical Systems and GE Medical Systems also have developed hybrid systems.

Positrace will carry a list price of $1.5 million, with most systems selling at a street price of about $1.1 million. SMV was able to bring the price of the system down by using 3/4-inch sodium iodide (NaI) scintillation crystals, rather than the bismuth germanate (BGO) crystals found on high-end PET cameras. The company used components outsourced from Analogic for the CT piece of the puzzle.

While Positrace's technical specifications aren't quite as good as a high-end PET camera, SMV believes that they are better than low-end PET cameras, and are far superior to gamma cameras outfitted with coincidence detection gear. The system has a resolution of less than 6 mm throughout the entire imaging volume, compared with 4 mm to 4.5 mm for a high-end PET camera. The minimum exam time is 25 minutes for 50 cm of coverage.

SMV also plans to emphasize the computing power available with Positrace. The system is available with the company's new PowerStation MP Xtreme workstation, which employs an IBM RS/6000 computer based on IBM's new copper chip architecture. SMV believes that a powerful computer is crucial when processing the complex data sets produced by hybrid imaging, Mixon said.

Finally, SMV plans to offer Positrace with an obsolescence protection plan. Users of the system will be able to receive free hardware and software upgrades for at least 24 months after their purchase. Positrace was designed specifically to enable rapid upgrades of hardware modules, according to Mixon.

The first North American installation of Positrace will be at MetroHealth Hospital in Cleveland. Another system will go in shortly at a hospital in Nantes, France, Mixon said. SMV is also taking orders for European shipments of the system.

SMV hopes that Positrace will ride the building wave of interest in fluorodeoxyglucose imaging, a wave that is being fed by generous Medicare reimbursement rates for PET procedures. The high rates have prompted many facilities to eschew gamma camera-based coincidence detection in favor of more expensive dedicated PET systems.

"Reimbursement is so substantial that clinicians are changing their strategy to include dedicated instrumentation," Mixon said. "Anyone who is serious about doing whole-body PET will be doing volumes that require a dedicated PET camera."

By Brian Casey
AuntMinnie.com staff writer
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