A Medical Device Daily

BOSTON – Electrophysiology (EP) is the fastest growing of all cardiovascular disciplines, as roughly 550,000 new patients are diagnosed with cardiac arrhythmias in the U.S. each year, according to Siemens Medical Solutions (Malvern, Pennsylvania)

“Demonstrating its ability to meet the evolving needs of today's electrophysiologists,” Siemens Medical Solutions said it is showcasing its comprehensive portfolio of EP solutions at the 27th annual scientific sessions of the Heart Rhythm Society (HRS; Washington) that began here Wednesday and continues through tomorrow.

The company also will highlight ultrasound applications for the assessment of patients with congestive heart failure and a new 3-D solution for atrial fibrillation (AF).

“Cardiac arrhythmias are being diagnosed at increasing rates,” said Kelly Feist, senior director, Cardiology Global Solutions, Siemens Medical Solutions. “Now more than ever before, electrophysiologists need efficient and effective solutions to diagnose and treat arrhythmic heart disease earlier, while driving down costs. By providing one of the industry's widest product offerings of EP solutions, Siemens arms electrophysiologists with the tools and information necessary to improve patient and clinical outcomes.”

Siemens will showcase complete solutions for the assessment of heart failure patients and cardiac resynchronization therapy (CRT) candidates with cardiovascular assessment methods that dramatically speed up clinical workflow.

At Heart Rhythm 2006, the company will highlight its suite of echocardiography tools for electrophysiology, including the new automated left ventricular quantification package.

For the first time, electrophysiologists not only have Doppler-based assessment tools for evaluating heart failure patients and synchronization of heart contraction using the Axius quantification synchronization tools, but also the ability to assess left ventricular dynamics in patients with heart failure using Axius velocity vector imaging technology.

In other HRS news:

• PDSHeart (Conyers, Georgia), which focuses on cardiac monitoring and arrhythmia management services, introduced an advanced auto detection atrial fibrillation monitor called the Dual Alert AF. The monitor uses proprietary algorithms to detect and record arrhythmias such as atrial fibrillation, tachycardia, bradycardia, and pause.

AF is relatively common and not usually considered life threatening if properly diagnosed and managed by a physician. The American Heart Association (Dallas) estimates that up to 2.2 million Americans suffer from AF annually. People with AF are more likely to have a stroke than those who do not have AF.

“The advanced algorithms in our monitor makes it the most sensitive and accurate AF event recorder in the industry,” said Sean Heyniger, president and CEO of PDSHeart. “The new Dual Alert AF with expanded auto detection parameters, increase sensitivity by as much as 50 percent over competing devices on the market. The new Dual Alert AF has also shown to reduce false positives significantly and identifies more asymptomatic patients than was ever possible. Early detection will greatly reduce the increased risks and potential for strokes for AF patients.”

• There is new hope today for the millions of Americans suffering from cardiac arrhythmia, according to Biosense Webster (Diamond Bar, California). The first fully automated ablation system supporting an open-loop irrigated catheter is now available in the U.S. through the company. The system incorporates the Thermocool irrigated tip catheter and Coolflow Pump from with the Stockert RF generator.

The Thermocool working together with this integrated system reduces char and thrombus formation during ablation, the company said.

With the recent approval of the Stockert Coolflow pump interface, the system “represents the first approach at fully automating operations between generator, pump and catheter,” the company said.

The Thermocool is designed to maintain safe tip-to-tissue temperatures, ultimately reducing the risk of coagulum and char from high-temperature ablation. The Coolflow Pump and the Stockert RF generator work in tandem allowing the physician to deliver desired power at a constant rate while performing automatic safety checks throughout the entire procedure, the company said.

• CardiacAssist (Pittsburgh), which makes cardiac assist devices, is exhibiting the TandemHeart PTVA System percutaneous left ventricular assist device (LVAD).

The TandemHeart system is designed to be used as a short-term extracorporeal circulatory support system for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant). The device has received FDA 510(k) clearance for short-term use and is the only FDA approved device of its kind in the U.S., the company said.

• LifeWatch (Buffalo Grove, Illinois), which focuses on cardiac arrhythmia telemonitoring, has announced plans to expand its products and service offering in the research, telemonitoring and telecare markets. These solutions will deliver the most advanced remote monitoring technologies and clinical services in the healthcare industry.

The telecare market has traditionally catered to chronically ill individuals or for those seeking one-time diagnoses. Yet today, large corporations and healthcare providers are seeking wellness telecare solutions to lower the healthcare premium costs and improve employee productivity, the company said.