Hansen Medical is a developer of robotic technology used for accurate positioning, manipulation and stable control of catheters and catheter-based technologies. The company has seen a flurry of activity of late, announcing the FDA clearance for commercialization of its Sensei Robotic Catheter System and Artisan Control Catheter, systems for manipulation, positioning and control of mapping catheters during electrophysiology (EP) procedures. Soon after, the company revealed that it has landed approval to begin marketing the system for use in the EU.
Health Imaging News spoke to Hansen President Gary Restani about what the availability of its systems could mean for electrophysiologists and patients.
What was the path to FDA clearance for Hansen’s Sensei system?
Hansen does have a rich history in robotics and was founded in 2002. Its co-founders Fred Moll, Rob Younge, and Dan Wallace, were the initiators. As co-founders of Intuitive Surgical they were instrumental in developing the da Vinci Surgical Robot, a minimally invasive approach to different types of surgery that utilized rigid endoscopic tools.
So, Fred Moll, Rob Younge, and Dan Wallace really played a major role in the pioneering of surgical robotics. They then moved to Hansen in 2002. The paradigm shift is that the Sensei Robotic Catheter System is designed to instinctively navigate flexible catheters, and that’s the primary differentiator. This is a flexible catheter that is really a percutaneous approach that allows greater stability and control in an interventional procedure. Whereby, the previous da Vinci is rigid and minimally invasive that uses ports to gain access to the anatomy.
As they developed the current Sensei product, they did so with support from clinical experience. Hansen’s current clinical experience includes 87 human patients that had very good results. All of these were performed in Europe by a number of notable U.S. electrophysiologists, and we have been able to develop a good deal of clinical experience which was part of our FDA submission.
The final phase of the FDA submission was in fact 20 patients done in December 2006, and that was the culminating event that took us to this approval.
What sort of feedback have you gotten from physicians?
The feedback from the physicians that have used the Sensei seems to indicate that the system will offer significant benefits to patients over current catheter-based systems. I don’t mean to compare this to other robotic systems, but rather to current manual procedures. This is what we’re hearing from physicians — not just clinical physicians — but a number of physicians that have come through our labs where we’ve demonstrated and allowed them to drive the unit in a lab setting. By making it easier for them to place catheters exactly where they are needed, they feel this will make quite a difference.
We’re trying to optimize the experience for the physician as we introduce them to the Sensei System. We have attracted some very strong Centers of Excellence both in Europe and in the United States, such as Cleveland Clinic, St. Mary’s Hospital in London, and another in Prague. As a result, we are establishing a strong base, and we will continue to use these sites to train and develop clinical data.
What’s the timeline and approach for initial commercial availability?
We’re going to adopt an approach which entails a managed placement strategy because we are very focused on optimizing the customer experience. For each placement we give them full clinical support during the initial procedure phase. It’s not really so much how many we can get out the door. We may be able to handle that manufacturing capacity-wise, but we want to handle it in a professional way that makes the experience optimal to the electrophysiologist.
We’re focused on quality installations, not just quantity. With that, we’ll meet investor expectations for 2007. We won’t give guidance on units to be shipped or sold for the next quarters, but in 2008 we’ll consider providing revenue
You recently signed a development and marketing partnership with St. Jude Medical. How might the FDA clearance impact that deal?
There are two agreements. One is a development agreement and the other is a co-marketing agreement. The work is starting but there’s an integration requirement in the sense that their system will be integrated with our system. To put it in a timeframe, we’ll probably work on that in the next few months