Using mapping catheters during electrophysiology (EP) procedures may have just gotten a bit easier.

Hansen Medical (Mountain View, California) has obtained FDA clearance to sell its Sensei robotic catheter system and Artisan control catheter designed to facilitate manipulation, positioning and control of mapping catheters during EP procedures.

The clearance allows physicians to use Hansen Medical's first generation robotic platform to easily place mapping catheters in hard-to-reach anatomical locations within the heart and maintain catheter stability during the diagnostic phase of complex cardiac arrhythmia treatment, Hansen said. According to the company, physicians who have used the product for EP procedures say the Sensei system has the potential to change the way cardiac procedures are performed to a more standard approach for complex diseases.

"The [current] gold standard is manual control of catheters and because catheters are flexible tools it can be very difficult to control … this is a way to transform a catheter into a surgical tool," Frederic Moll, MD, founder/CEO of Hansen Medical, told Medical Device Daily.

Moll said Hansen has been working on getting FDA clearance for the Sensei system for about three years. Still, the clearance came a bit earlier than expected.

"Hansen Medical is very pleased with the FDA's clearance for the Sensei system, particularly since we previously projected that this clearance would be granted in the second half of 2007," Moll said. "Our direct sales force coupled with our clinical applications specialists can now initiate the sales process and leverage the relationships they have established with leading hospitals throughout the country."

Moll said the company plans to launch the system in the U.S. this quarter.

"By offering physicians the freedom to extend their reach into areas of the heart through a robotically controlled catheter that offers instinctive and deliberate catheter guidance, we believe we can ultimately help physicians to better perform complex catheter procedures and contribute to the successful diagnosis of life threatening cardiac diseases," Moll added.

Currently, as Moll noted, cardiac mapping procedures performed as part of the treatment of patients suffering from abnormal heart rhythms are done using a manual technique. 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 said it 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.

Moll told MDD physicians who have used the Sensei system already have reacted "extremely positively" to the device.

"We've done about 90 cases and they've all gone very well, and the clinicians are excited about the increased stability and control," he said.

Andrea Natale, MD, 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 (Cleveland), used the Sensei system during clinical evaluation on 25 patients in the Czech Republic and Germany, Hansen Medical said.

"The stability of the Artisan catheter allowed us to perform catheter mapping procedures more efficiently and effectively," Natale said. "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 also recently reported an agreement with St. Jude Medical (St. Paul, Minnesota) to integrate technologies from its Sensei robotic catheter system and Artisan control catheter with St. Jude's EnSite system (Medical Device Daily, May 10, 2007).

The EnSite system is a computer-based technology marketed worldwide designed to facilitate EP procedures by creating real-time 3-D 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.

Moll said Hansen Medical's collaboration with St. Jude is also "a real positive thing" for the company.

The new robotic catheter system is compatible with fluoroscopy, ultrasound, 3-D 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.

Hansen Medical 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.

No Comments