Medical Device Daily

CHICAGO — Healthcare companies use meetings such as the Radiological Society of North America (Oak Brook, Illinois), ongoing here at the mammoth McCormick Place Convention Center through week’s end, to debut new products that they claim will have a significant impact on clinical healthcare.

Among these many claims, one new system stands out from the crowd at this year’s meeting as having the transforming potential to greatly speed the delivery of necessary care.

At a press conference Toshiba America Medical Systems (TAMS; Tustin, California) unveiled what it says is the world’s first dynamic volume CT system, dubbed AquilionONE. AquilionONE is a diagnostic imaging system with the potential to revolutionize patient care by greatly reducing the time to diagnosis life-threatening diseases such as heart disease and stroke — from days and hours to what company VP of marketing John Zimmer termed “mere minutes.”

Zimmer told Medical Device Daily that with the AquilionOne, physicians can see not only a 3D depiction of an organ, but also the organ’s dynamic blood flow and function. Unlike any other CT system, it can scan one organ — including the heart, brain and others — in one rotation because it covers up to 16 cm of anatomy using 320 ultra-high resolution 0.5 mm detector elements.

This reduces exam time, as well as radiation and contrast dose, dramatically increasing diagnostic confidence, Zimmer said. A single organ or area of the body can be captured in one rotation, at one moment in time, eliminating the need to reconstruct slices from multiple points in time.

He called this “a truly disruptive approach ... that allows faster diagnosis that leads to earlier treatment and better patient outcomes.”

Apparently, the Cleveland Clinic agrees with Zimmer’s assessment. Last month it placed dual-source CT at No. 10 on its “Top Ten” medical innovations of 2008 list (MDD, Oct. 5, 2007).

With its ability to perform uniquely comprehensive exams, including functional studies, Zimmer said the system reduces the use of duplicative tests and invasive procedures, hence offering a great decrease in healthcare costs. Heart disease and stroke diagnostics alone have been estimated at $432 billion in the U.S. for 2007.

Rich Mather, PhD, CT senior clinical sciences manager for TAMS, noted that, typically, patients presenting at the ER with chest pain may be given multiple tests — from EKG, calcium study, CT angiography (CTA), to nuclear testing and catheterization — to sort out the one cause from many possibilities. These tests can take more than 24 hours to complete and may expose the patient to significant radiation and contrast dose, with costs of more than $4,000.

With the AquilionONE, he said that a single comprehensive exam can give physicians all of the information they need to diagnose and treat the patient in less than 20 minutes, with significantly less contrast and radiation dose, and at a cost of about $1,000.

He said the savings are not just in dollars but in lives.

Mather noted especially the need to accurately identify and treat stroke quickly — stroke often offering only a three-hour window for successful therapy to be administered.

Typically, stroke patients will be taken first to the hospital’s CT system. But traditional CT results can be inconclusive, making necessary additional tests such as MRI exams, extending diagnosis time to as much as four hours or more.

TAMS says that with AquilionONE, and its quick acquisition of functional data, this time to diagnosis can be great reduce, with less radiation and less use of contrast agent.

The system was cleared by the FDA lat month. And Doug Ryan, senior director of TAMS’ CT business unit, said that the system is the culmination of nearly a decade of R&D work, costing the company about $500 million to see it through to completion.

“We didn’t get there overnight,” Ryan said. He said that the company produced three prototypes of the system to iron out all kinks. One of the biggest changes, he said, was boosting the number of detector elements from 256 to 320 fairly late in system development.

“It became very obvious in the device testing of prototype three that 256 elements was not going to be enough. The feedback we got was that once we started doing testing on the system, not only was the volume coverage discovered to be an issue but also the reconstruction.”

By increasing the coverage by 25%, he said, the company was able to do whole heart and brain scans.

While the system may enjoy its most extensive use in heart and brain scans, a physician from Johns Hopkins University (Baltimore) — where some of the beta testing of the device took place — was quick to point out that this is a whole body scanning system.

“It would be particularly good at watching change over time in something because you get such coverage you can watch motion, which we traditionally don’t get with CT,” Kieran Murphy, MD, director of interventional neuroradiology at Johns Hopkins, told MDD.

While the system may ultimately reduce healthcare costs, this innovation won’t come cheaply for hospitals. Ryan put the estimated price tag at between $2.5 million and $2.8 million.

Commercial release of the AquilionOne is targeted for the summer of 2008.

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