Medical Device Daily European Editor and Staff Reports

For European radiology centers on a limited budget, Toshiba Medical Systems Europe BV (Zoetermeer, the Netherlands) has introduced the Aquilion Premium, a 160-detector row computed tomography (CT) scanner with software and hardware options allowing an upgrade to research-quality images equivalent to the flagship 320-slice AquilionONE.

Three systems have been sold with two currently being installed in Russia and one in Italy, Toshiba' Europe's senior manager for marketing, Jack Hoogendoorn, told Medical Device Daily.

"Aquilion Premium is the only system that can be upgraded from eight centimeter to 16 cm coverage to unlock all the advantages of our AquilionONE CT dynamic volume scanner, which means a safe and sound investment for future for customer needs," he said.

The Aquilion Premium scanner covers 80 mm with a 160-detector row in a single rotation and by using the reconstruction algorithms in the coneXact software, the scanner generates a 320-slice, 3-D volume image.

The good news regarding the narrow coverage of the 160 in-line Quantum detectors is a smaller detector aperture of just 0.5mm, the world's smallest available in CT technology, according to Toshiba, providing fine and fast dynamic volume images for functional CT at low radiation dosages in a single rotation.

The downside is the Aquilion Premium restricts the range of clinical applications to narrow coverage areas, such as the heart or the brain.

The Aquilion Premium can be upgraded with a retrofit to 320-detector rows and 160 mm coverage, generating 640 slices per rotation, the same as the AquilionONE.

Aquilion Premium customers are given a range of software packages on six-month trial basis to experience the advantages of advanced clinical imaging and if convinced of the clinical benefits, and able to come up with the budget, can progressively upgrade capabilities.

"Experience teaches us that the selection of optional software packages can be difficult, and is complicated by budget restrictions," explained Hoogendoorn, adding that as clinical needs emerge a customer may find a need for a different choice of software than originally selected.

For the moment the scalable, upgradable Aquilion Premium platform is only available in Europe, he said.

Eighteen months ago Toshiba made waves at the 2007 Radiological Society of North America meeting in Chicago when it introduced the AquilionONE, a CT scanner featuring a world-first 320-slice architecture, announcing it had pre-sold five units and then winning a purchase from the National Institutes of Health. (MDD, Dec. 9, 2008).

The new capabilities of a wide, dynamic volume approach created several clinical advantages by eliminating the stitching of multiple images that create image artifacts, and by lowering radiation doses by as much as 80% according to Toshiba.

The Aquilon Premium is loaded with Toshiba's trademark IT capabilities, including on board, storage for up to 800.000 images for immediate access retrieval and what the company is calling "Enhanced DICOM" (Digital Imaging and COmmunications in Medicine) that increases the transfer speed up to 10 times so that the transfer of 1,200 images, which would normally take over three minutes, is completed in 20 seconds.

CE mark for TactiCath

Endosense (Geneva, Switzerland), a company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, reported receipt of the CE mark for its TactiCath system.

The first force-sensing ablation catheter, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium.

"The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias," said Eric Le Royer, president/CEO. "With its unique ability to measure contact force, we expect the TactiCath to have a major positive impact on the safety and efficacy of catheter ablation, while also standardizing ablation techniques and decreasing the learning curve."

The CE mark was granted based on select data submitted from Endosense's TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by 17 investigators at eight European centers. During procedures on 42 enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached.

"The availability of the TactiCath marks an important advance in the field of catheter ablation," said Karl-Heinz Kuck, MD, of Asklepios Klinik St. Georg (Hamburg, Germany), an Endosense European scientific advisor and primary investigator of the TOCCATA trial. "The TactiCath is a critically important addition to our treatment armamentarium, as it will help to prevent perforation and identify sites of low contact force which may lead to re-conduction from the pulmonary veins in patients undergoing atrial fibrillation ablation."

Acute data from the TOCCATA study will be presented at the Heart Rhythm Society's 30th annual scientific sessions in Boston next week.

Endosense said it plans to release the TactiCath system in Europe in the second half of 2009.