The company also announced initial shipments of Sensei systems into the European market, as well as the establishment of its first Centers of Excellence to support training and demonstration activities. The Centers are located at St. Mary's Hospital in London and the Cleveland Clinic Foundation in Ohio, both under the guidance of world renowned electrophysiologists Wyn Davies, M.D., in London and Andrea Natale, M.D., in Cleveland.
"We are thrilled to be heading to the Heart Rhythm Society meeting with both FDA clearance and joint development and co-marketing agreements with St. Jude Medical accomplished", stated Frederic Moll, M.D., founder and chief executive officer of Hansen Medical Inc. "Both of these achievements will allow Hansen Medical to begin executing its marketing strategy, and we are anticipating rapid adoption of this technique in the treatment of complex cardiac diseases. Our direct sales force in the United States and our European representative with direct sales responsibility in the United Kingdom and Benelux countries have already begun to see positive results from the relationships they have with leading hospitals."
The Sensei system and Artisan catheter are 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 Sensei system offers accuracy and control in a flexible platform for navigation during complex catheter mapping procedures", stated Wyn Davies, M.D., FRCP, FHRS, consultant cardiologist, St. Mary's Hospital, London, the company's first Center of Excellence. "The new robotic system allows the operator to perform EP procedures in a more consistent fashion, which I believe will lead to the development of a standard approach for complex diseases."
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 complex procedures. Currently, a majority of clinicians continue to manually guide catheters through the heart to detect and treat a variety of cardiac arrhythmias. The technique requires physicians to perform a series of complex manipulations at one end of the catheter with inadequate assurance that the tip of the catheter will respond as desired while inside a patient's heart.
Achieving stable contact at anatomic sites within the heart, which is essential for successful mapping procedures, can be difficult. As a result, insufficient contact between the catheter tip and the inside of the heart wall can lead to highly variable and less than optimal procedure results for the patient. Hansen Medical believes its robotic platform overcomes these hurdles and will enable physicians to perform procedures that historically have been too difficult or time consuming to accomplish routinely with existing manual technique.
The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The two main components that comprise the system are the Artisan control catheter and an ergonomically designed, remotely-placed workstation where the physician is seated throughout each procedure. In addition to lessening operator fatigue, the remote workstation creates a virtual shield for physicians against harmful radiation.
The open architecture provided by the Sensei system, which allows the use of pre-approved catheters from third-party manufacturers, requires a labeling 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. The Sensei system has received CE mark approval in Europe, and the Artisan Control Catheter is currently pending CE mark approval.
As stated, Hansen Medical has entered into joint development and co-marketing agreements with St. Jude Medical of St. Paul, Minnesota, a global expert of electrophysiology technology, to integrate technologies from its Sensei Robotic Catheter System and Artisan Control Catheter with St. Jude Medical's EnSite System.
The EnSite system is a computer-based technology marketed worldwide that facilitates EP procedures by creating real-time 3D graphical displays or maps of cardiac structures and arrhythmias. These maps are designed to provide the visual guidance necessary to navigate catheters used during EP procedures. Previously, two dimensional technologies such as fluoroscopy or ultrasound were used to assist physicians with guiding catheters inside the heart, which is a three-dimensional space. Combining the Sensei and EnSite technologies is intended to provide physicians with 3D visualization that will augment their ability to confidently move a catheter throughout the heart, as well as greatly increase control over placement of the catheter in specific locations.
"This joint development agreement facilitates an advanced level of integration of the Sensei system with one of the market-leading 3D mapping technologies for EP", stated Frederic Moll. "Integration of the Artisan catheter within the EnSite System's 3D map will give physicians the ability to move the catheter deliberately and accurately while seeing specifically, in three dimensions, the location of the catheter inside the heart. This is an important step toward achieving automation of EP procedures, which we believe is key to providing clinicians of varying skill levels the ability to more effectively and safely treat complex cardiac arrhythmias."
"Now that we have received regulatory clearance, St. Jude Medical will be partnering with Hansen Medical in the marketing of integrated solutions for electrophysiologists and placement of Sensei systems into accounts that are recognized as leaders in the field of cardiac rhythm management. This will leverage our existing sales force in a very focused and streamlined manner", continued Dr. Moll.
The EnSite System is used by EP clinicians during EP procedures to create 3D models of their patients' cardiac anatomy and then to visualize catheters used in those procedures as they are navigated to critical anatomical targets. The system collects and organizes activation and voltage data from the inner surface of the heart, which allows physicians to visualize arrhythmias on the 3D model and more easily determine a treatment strategy.
"This agreement allows both companies to demonstrate the combined power of fully integrating capabilities of the Sensei and Ensite Systems", stated Jane Song, president, St. Jude Medical Atrial Fibrillation Division. "St. Jude Medical looks forward to working closely with Hansen Medical to integrate the two companies' technologies and further develop this innovative approach to how physicians perform complex EP procedures today and in the future."
The joint development and worldwide co-marketing agreements between St. Jude Medical and Hansen Medical are two-year agreements. Under the terms of the joint development agreement, St. Jude Medical and Hansen Medical will exclusively co-develop technology that will enable the integration of the Sensei and Ensite Systems. Under the terms of the co-marketing agreement, St. Jude Medical has exclusive co-marketing rights to market the Sensei System with St. Jude Medical products in targeted EP accounts.
Hansen Medical is also pleased to have obtained United States Food and Drug Administration clearance for commercialization of the Sensei Robotic Catheter System and Artisan Control Catheter. Andrea Natale, M.D., director for the Center for Atrial Fibrillation, director of the Electrophysiology Laboratories and head of the Section of Pacing and Electrophysiology at the Cleveland Clinic Foundation, used the Sensei system during clinical evaluation on 25 patients in the Czech Republic and Germany.
"The stability of the Artisan catheter allowed us to perform catheter mapping procedures more efficiently and effectively", stated Dr. Natale. "Moreover, the incorporation of the new Sensei system and catheter did not add time to the procedures, nor did it require increased radiation time, as would normally be expected with new technology. As a result, I would expect this new system to become the medical standard for performing complex EP procedures, which are currently limited to those individuals with the highest level of skill."
Hansen Medical, based in Mountain View, California, was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies. More company news is available in the VMW June 2006 article Hansen Medical introduces new robotic catheter technology for accurate 3D control during cardiac procedures.