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Hansen Medical is first to offer remote navigation of irrigated catheters in EU

Hansen Medical : 09 October, 2007  (New Product)
Hansen Medical has installed a total of five Sensei Robotic Catheter systems in the USA and four in Europe since receiving both FDA and CE Mark clearance in May 2007.
The installation sites range from large teaching institutions and university medical centres to community hospitals, and, as a result, those patients now have access to a more sophisticated level of cardiac arrhythmia treatment within their communities.

With the Sensei system, physicians of differing skill level are able to successfully employ this remote Catheter navigation system within their practices. Additionally, certain physicians in the European Union are able to combine the use of the Sensei system's remote navigation capability with state-of-the-art irrigated catheters to deliver more effective therapy during complex cardiac procedures.

'We have successfully performed more than 26 cases using the new Sensei system with irrigated Catheter technology,' said Professor Stephan Willems, director of Clinical Electrophysiology at the University Heart Center, University Hospital Hamburg-Eppendorf, which is also the site of the first Sensei system installation in Germany. 'The accuracy and control the robot offers during Catheter ablation procedures is superb, and provides a great level of stability in difficult-to-treat locations for atrial fibrillation and atrial flutter patients. As a result, we are treating several patients with the Sensei system in our lab each week.'

Electrophysiology is one of the fastest growing of all cardiovascular disciplines, which is highlighted by the fact that an estimated 550,000 new patients are diagnosed with cardiac arrhythmias in the USA each year (Ref 1). In the third quarter of 2007, a total of 101 clinical procedures were performed worldwide by physicians using the Sensei system, and approximately 114 procedures have been performed since the product's release in May 2007.

In Europe, Hansen is the only company to provide robotic control of irrigated ablation Catheter technology for atrial fibrillation because its remote navigation system has an open architecture. This open architecture permits the use of irrigated catheters, which are approved to treat atrial fibrillation in Europe - a major cause of stroke and heart failure.

Irrigated catheters prevent the formation of dangerous clots on the tip of the Catheter during ablation procedures. As a result of this technology, ablation procedures and treatment in Europe are more effective and the risk of stroke is expected to be significantly decreased. The combination of the Sensei system's ability to accurately position catheters at targeted cardiac anatomy along with the more effective lesions created by irrigated catheters should have a powerful effect on procedure outcomes.

'With cardiac arrhythmias being diagnosed at alarming rates annually, it is imperative that electrophysiologists of all skill levels are equipped with effective solutions to help them detect, diagnose and treat heart disease earlier,' said Frederic Moll, MD, founder and CEO of Hansen Medical. 'The adoption of our technology within a broad range of hospitals and medical centres is extremely encouraging to us in our efforts to help improve clinical outcomes.'

Hansen Medical has two centres of excellence - The Cleveland Clinic, in Cleveland, Ohio, and St Mary's Hospital in London. Training, research and future clinical development take place at both centres where large volumes of highly complex cases are performed. With further development underway at the two centres, the company hopes the new robotic navigation system will simplify the mechanics of performing complex procedures so that physicians will have the opportunity to treat more patients and ultimately reduce the clinical risk of atrial fibrillation.

The Sensei system is designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during the diagnostic phase of complex cardiac arrhythmia treatment. The system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data.

The open architecture provided by the Sensei system, which allows the use of pre-approved catheters from third-party manufacturers, requires a labelling addition from the FDA. The addition is intended to remind physicians that the safety and effectiveness of the system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.

Ref1 Statistics provided from the Heart Rhythm Society and the American College of Cardiology.
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