Hansen Medical Showcases Revolutionary New Catheter Control System --CCS-- for Electrophysiology Procedures
As the trend from open surgical procedures to less invasive percutaneous procedures continues, tools that facilitate access to critical anatomy are needed so that physicians can more effectively and safely perform these percutaneous procedures. To date, a majority of clinicians continue to manually guide catheters through the heart to detect and treat a variety of cardiac arrhythmias despite the lack of precision offered by these catheters. The Hansen CCS, which is being shown here at HEART RHYTHM 2005, the Heart Rhythm Society's 26th Annual Scientific Sessions, May 4-7, 2005, could change the way physicians perform percutaneous cardiac procedures. It is the first technology to combine computed movement with an electromechanically controlled catheter, and integrate the technology into a workstation that can be placed away from radiation exposure.
"To have precise control of an ablation catheter in a flexible and simple platform for navigation within the cardiac chambers, and to be able to achieve this from a remote location could make ablation of complex arrhythmias, including atrial fibrillation, significantly easier and more feasible for all clinicians," said Andrea Natale, M.D., director of the Electrophysiology Lab and co-section head of Pacing and Electrophysiology, Cleveland Clinic Foundation. "During pre-clinical trials, this novel, robotic control system demonstrated that control and placement of cardiac catheters through a steerable guide catheter could be accomplished.
"Additionally, because care of patients suffering an embolic stroke resulting from atrial fibrillation is a costly medical concern, and patients who suffer from these strokes are often unable to function well enough to maintain a satisfactory quality of life, it is imperative that the medical community continue to research and develop technology to address the frequency of this condition," continued Dr. Natale.
Pre-clinical studies for the Hansen CCS were conducted to evaluate the ability of the guide sheath and steerable guide catheter to remotely navigate an ablation catheter to a series of anatomical targets in the right and left atria. Placement of radiofrequency (RF) ablation lesions and control of 3D surface-mapping catheters were also assessed. The results of these studies suggest that the Hansen CCS offers an effective alternative to manual control for placement and manipulations of such catheters.
"We have designed the Hansen CCS to enhance the speed and safety of catheter-based therapeutic procedures by offering physicians precise control over catheter placement, at a level not achievable with existing interventional techniques," said Fred Moll, M.D., founder and CEO of Hansen Medical. "This proprietary technology may lead to a greater number of physicians able to perform complex interventional procedures, such as treating atrial fibrillation, with successful outcomes while possibly decreasing the incidence of embolic stroke."
According to the American Heart Association's (AHA) Heart Disease and Stroke Statistics 2005 Update, atrial fibrillation increases the risk of stroke five-fold, and people who suffer a stroke caused by atrial fibrillation are 2.23 times more likely to be bedridden, compared to patients who have strokes from other causes. Approximately 700,000 Americans will experience a new or recurrent stroke this year, which translates into a frequency of one stroke every 45 seconds. Stroke is the nation's third leading cause of death, ranking behind diseases of the heart and cancer.