FDA Clears New, Smaller Ultrasound Catheter from Siemens for the Visualization of Entire Heart During Non-Invasive Procedures.

ORLANDO, Fla. -- Company to Showcase Encompass Release for ACUSON Sequoia Platform at ACC 

Offering the medical community an even smaller, powerful tool to visualize the entire heart during diagnostic and therapeutic procedures, Siemens today announced it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market the new ACUSON AcuNav(TM) 8F ultrasound catheter. The new catheter, sized at eight French, is 33 percent smaller in the cross sectional area than the existing AcuNav 10F catheter and enables improved access in all patients, particularly smaller patients for left heart applications in electrophysiology and interventional cardiology.

The company will showcase the new 8F catheter as well as the Encompass Release(1) for the ACUSON Sequoia(TM) C256 and C512 echocardiography platforms during the 2005 American College of Cardiology (ACC) Annual Scientific Sessions in Orlando, Fla., held from March 6 to 9 (booth # 441).

According to clinical evaluators of the AcuNav 8F catheter, the smaller size coupled with the same high resolution and depth of imaging as the existing AcuNav 10F catheter is a significant improvement and allows access to a wider range of patients.

"The size and flexibility of the new catheter were very impressive and provided us with improved visualization of defects with less trauma to the patients," said Ziyad M. Hijazi, M.D., MPH, section chief of pediatric cardiology and professor of pediatrics and medicine, University of Chicago. "During evaluation, I performed two atrial septal defect (ASD) closure procedures and one patent foramen ovale (PFO) procedure on a total of three patients, two being quite small, and the third weighing just over 260 pounds. With the 8F, I was able to get spectacular images of clinical significance with no problem at all."

Dr. Hijazi and other clinical evaluators say the new catheter will change the way ASD closure procedures are performed in smaller patients. "There will be no need to use transesophageal echocardiography (TEE) in small patients, and the operator will be able to perform the echocardiographic evaluation and the closure simultaneously, therefore the resources in the department will be used more efficiently," said Dr. Hijazi.

The new, smaller catheter provides visualization of vascular and cardiac anatomy and physiology, measurement of blood flow and visualization of other devices throughout the entire heart. According to Dave Bruce, general manager of the AcuNav group, Siemens Ultrasound Division, "The trend in cardiac procedures is toward less invasive surgery, going from open surgery to keyhole access, and now to catheter-based procedures, which demands new visualization techniques. The ability of intracardiac echocardiography to see anatomy and devices under blood will enable many new applications such as mitral and aortic valve repair using catheters, and will accelerate the adoption of catheter-based procedures that reduce trauma and recovery time for patients."

The AcuNav 8F catheter is currently available on the Sequoia ultrasound platforms, the ACUSON CV70(TM) cardiovascular system and the ACUSON Cypress(TM) cardiovascular system.

In addition to the 8F catheter, the company will highlight a new approach to optimizing ultrasound imaging using patient specific tissue characteristics called Native(TM) patient specific imaging technology. Patient specific imaging technology, which is part of the Encompass release for the Sequoia platform, not only offers instant optimization for each individual patient's blood flow, but also significantly reduces keystrokes with hands-free gain control to streamline workflow and improve user ergonomics.

"The ability to place a transducer on the chest wall and have the echocardiography system immediately give you an optimal image is a significant advance in ultrasound imaging," said Manni A. Vannan, MBBS, FACC, professor of medicine, associate chief of cardiology, University of California at Irvine, Orange, Calif. "This technology enables clinicians and sonographers to spend more time concentrating on pathology and anatomy with each individual patient type, especially those who are extremely large and difficult-to-image, rather than worrying about the system and various keystrokes."

The company also demonstrated new advancements on the ACUSON CV70(TM) cardiovascular system, including the P9-4(1) pediatric transducer and fourSight(TM) view for integrated three-dimensional (3D) transesophageal (TEE) imaging. Through advanced technology migration from the Sequoia platform, 3D TEE imaging is now available with the CV70, enabling easier access to 3D/4D images inside the operating room for review, manipulation and dynamic display of gated 3D datasets using the V5Ms TEE transducer. Transesophageal echocardiography ultrasound can provide physicians a more detailed, anatomical display of the heart and clinical disease processes with the highest image quality. This is especially important for valve repair procedures.

Siemens Medical Solutions of Siemens AG (NYSE:SI) is one of the largest suppliers to the healthcare industry in the world. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. From imaging systems for diagnosis, to therapy equipment for treatment, to patient monitors to hearing instruments and beyond, Siemens innovations contribute to the health and well-being of people across the globe, while improving operational efficiencies and optimizing workflow in hospitals, clinics, home health agencies, and doctors' offices. Employing approximately 31,000 people worldwide and operating in more than 120 countries, Siemens Medical Solutions reported sales of 7.07 billion EUR, orders of 8.12 billion EUR and group profit of 1.05 billion EUR for fiscal 2004. Further information can be found at http://www.usa.siemens.com/medical-pressroom.

(1)The P9-4 transducer and the Encompass release are not yet commercially available.

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