A CDU

The major makers of medical imaging products were among the companies seeking to gain market traction from the presence of 12,000 attendees during the 17th annual Transcatheter Cardiovascular Therapeutics (TCT) symposium, joining a stellar list of cardiovascular device manufacturers represented on the Washington Convention Center exhibit floor in mid-October.

As is usual at such gatherings, GE Healthcare (Waukesha, Wisconsin) cut quite a swath with its exhibit space and flurry of product announcements, including the unveiling of a new cardiovascular imaging system that the company said would enhance clinicians’ ability to diagnose and treat heart disease and enable more precise placement of interventional devices such as stents, balloons and filters.

GE said the Innova 2100^IQ, a cardiac X-ray system that enables cardiologists to clearly visualize fine vessels from the heart to the legs both during diagnostic procedures and during device placements, was developed in partnership with a team of leading interventional cardiologists, based on clinical needs in the cardiac cath lab.

The company said the Innova 2100^IQ would play “a critical role in helping clinicians treat a growing number of chronic heart and vascular conditions, including atherosclerosis.” The American Heart Association (Dallas) says atherosclerosis causes hundreds of thousands of heart attacks and strokes each year and accounts for nearly three-fourths of all U.S. deaths from cardiovascular disease.

Stanley Katz, MD, chief of cardiology at North Shore University Hospital (Manhasset, New York), said that one of the biggest challenges in interventional cardiology today is clearly visualizing the finest vessels and intricate anatomy of the heart. “The Innova 2100^IQ addresses this challenge by providing enhanced image quality, which enables cardiologists to more precisely perform ... operations on patients with heart disease.”

More than 1,200 Innova family systems are installed worldwide, and GE said more physicians rely on such systems to help them diagnose and treat cardiovascular disease than any other all-digital flat panel system. “We’ve completed more than two dozen clinical studies which demonstrate Innova’s superior image quality,” said Laura King, vice president of global interventional, cardiology and surgery for GE Healthcare.

Toshiba America Medical Systems (TAMS; Tustin, California) demonstrated the five-axis Infinix CF-i/SP (single plane) diagnostic and interventional imaging system, which it said delivers “unprecedented head-to-toe and fingertip-to-fingertip patient access.”

The floor-mounted Infinix CF-i/SP’s five-axis design permits easy shifting of the C-arm around the exam table for optimal angling, TAMS said. The system also is equipped with Toshiba’s 8-inch cardiac flat panel detector mounted on a fifth axis, which rotates exactly as the C-arm rotates to the side. This fifth axis results in images always being maintained in a heads-up orientation while the C-arm rotates.

The system was designed using Toshiba’s Voice of the Customer feedback program, which utilizes clinician feedback to guide future product development.

“The opportunity to review and operate with Toshiba engineers this new technology was a view to the future of all catheterization laboratories,” said Ronald Karlsberg MD, clinical professor of medicine at the University of California, Los Angeles David Geffen School of Medicine director of the cardiac cath lab at Brotman Medical Center.

“The development of five-axis technology sets a new standard for floor-mounted systems. With this system, even lower leg and radial access to patients is achieved quickly and easily for patients of all sizes. There is complete open access to the patient and even with the C-arm rotated to the side, the head is always up for proper anatomic orientation.”

Other features of the Infinix CF-i/SP include what Toshiba America said is the industry’s highest anode heat-capacity liquid metal bearing tube of 3.0 MHU, which the company said “virtually eliminates” overheating and increases overall throughput and efficiency. The liquid metal tube allows for immediate image capture.

“[The] Infinix CF-i/SP delivers unparalleled performance and allows clinicians to image virtually any region of the vascular anatomy,” said Don Volz, director of the Vascular and X-ray Business Unit at Toshiba. “This system is a great addition to our full line of cardiac catheterization systems.”

Other configurations of the company’s family of Infinix-i series catheterization systems for cardiac applications include single-plane floor-mounted, single-plane ceiling-mounted, and bi-plane and dual-plane, flat-panel detector systems.

Another major player in the imaging products market, Siemens Medical Solutions (Malvern, Pennsylvania), unveiled integrated technology solutions that it said would help cardiologists address tighter budgets, time-pressured staffs and demands for quality patient care.

Manfred Fink, vice president of Siemens’ Angiography and X-ray Division, said, “We want to ... give cardiologists new and better tools to save lives and improve patients’ journeys from early detection, through treatment and follow-up.”

Among the technologies showcased by Siemens Medical Solutions as part of its integrated cath lab solution were:

• The Axiom Artis with large flat-detector 30X40 configuration, a fully digital, ceiling-mounted cardiac imaging system designed to connect the cath lab as an integral part of the hospital’s cardiology department. The system, which enables cardiac and peripheral applications, offers what Siemens terms “a unique design for accessibility to the patient.” It also provides access to computed tomography (CT) and MRI, arming cardiologists with additional information needed for effective treatment planning.

• The Axiom Sensis hemodynamic and recording system, designed to improve workflow in the cath lab. The system provides accurate calculations of hemodynamic and electrophysiologic data obtained during catheterization, and presents that data concisely to allow clinicians more time to spend with the patient. Physicians are able to create a comprehensive patient report during the exam, including stored reference images, and complete the patient report seconds after finishing the procedure.

• The Axiom Artis Wireless Footswitch and Voice Control. Siemens said the wireless footswitch eliminates the hazard of excess cables often found in the exam room and reduces the risk of tripping. With Artis Voice Control, parts of the Axiom system can be controlled through hands-free operation, easing workflow and increasing patient throughput. Both Artis Wireless Footswitch and Artis Voice Control are pending 510(k) review and are not yet commercially available in the U.S.

• Also showcased was the new Acuson AcuNav 8F ultrasound catheter. Sized at 8 Fr, it is 33% smaller in the cross-sectional area, yet provides the same high resolution and depth of imaging as the AcuNav 10F catheter. The company said the smaller size enables improved access during closure of atrial septal defects on smaller patients and left heart applications for both interventional cardiology and electrophysiology, bringing intracardiac echocardiography to a wider range of patients.

Providing visualization of vascular and cardiac anatomy and physiology, measurement of blood flow and visualization of other devices throughout the entire heart, the AcuNav 8F catheter currently is available on the Acuson Sequoia ultrasound platforms, the Acuson CV70 cardiovascular system and the Acuson Cypress cardiovascular system.

• syngo Circulation, a dedicated cardiovascular CT solution designed to fast-track robust morphological and functional analysis and reporting in one software application, which recently received FDA clearance. Available on the Somatom Sensation CT system, Siemens said it guides the clinician through cardiac evaluation from automated heart and coronary vessel segmentation, to stenosis quantification, to fully automated functional analysis and reporting, in less than 10 minutes. “With a single click, the heart can be isolated from the rib cage, facilitating rapid assessment of the overall cardiac anatomy and optimized stent planning,” the company said in a statement.

• Soarian Cardiology, an information solution designed to address the specific clinical, financial and operational workflow challenges of the cardiac care team, ties the entire cath lab solution together. Siemens said Soarian Cardiology allows users to build a continuous, comprehensive electronic patient record that includes medications, lab results, images, ECG, physiological waveforms and documentation.

• The KinetDx Network, a multi-modality, dynamic image review, diagnosis and archiving system using evidence-based reporting to help improve the efficiency of clinical procedures. The scalable solution provides similar benefits for offices, imaging clinics, hospitals and multi-facility enterprise health systems. Siemens said optional interfacing to clinical or hospital information systems expands the benefits by simplifying the distribution of results in a variety of formats, helping facilities create a filmless and paperless environment.

Also at TCT, Acist Medical Systems (Minneapolis), a Bracco Group (Milan, Italy) company providing automated contrast delivery systems, introduced the Acist CVi Contrast Delivery System for cardiovascular angiographic procedures. The product combines all of the features of the Acist CMS and Voyager systems onto one platform.

“The new CVi combines enhanced ease of use with the reliability and flexibility that clinicians have come to expect from Acist,” said Chairman Fulvio Renoldi Bracco. “Preliminary customer feedback has been excellent, and I am confident that the Acist CVi will further enhance both workflow and productivity in the angiographic suite.”

Acist said this fourth-generation product enhances the ease of contrast and saline injection for physicians, nurses and technicians with the several new system benefits, including straightforward, intuitive setup of the system and disposables, designed to provide the clinician with more freedom to focus on the patient; procedural flexibility and workflow through provision of one contrast delivery system for both cardiac and vascular angiography; versatility of equipment setup, with the lower-profile, table-mountable injector and extendable control panel able to be placed where it is needed most and with less interference.

With more than 800,000 procedures conducted on its systems annually, Acist said it is a leading player in precision, user-controlled, variable-rate delivery of contrast media for both large- and small-vessel angiography.