Francis Macnamara, VP of Advanced Technology at Hansen Medical, talked about their proprietary intravascular robotic catheter system at www.bio2devicegroup.org event.
Hansen Medical was found in 2002, as an alternate to Intuitive Surgical’s robotic surgical tools. Intuitive’s tools are rigid tools that require incision closer to the organ, said Macnamara. A flexible device can go in through the femoral artery and can get a flexible catheter inside, with the control of the robots. Sensei system was Hansen Medical’s first electrophysiology based robotic navigation system that offered catheter stability with force sensing, with a potential for reduced fluoro for physicians, and instinctive 3D control at the tip. Sensei systems mapped out the heart, prior to doing the ablation. Hansen Medical has now unveiled a new catheter system, the Magellan Robotics Catheter System.
But first, how big is the EP market and what is the prevalence of AF or atrial fibrillation? About 3.1 M Americans suffer from AF. Atrial fibrillation is the most common arrhythmia in elderly persons and it creates a huge potential risk for stroke. In 2012, the US, market for cardiac rhythm management (CRM), electrophysiology, and ablation devices, was valued at $6.8 billion. Worldwide, over 13,000 AF procedures are done annually, said Macnamara. Over 1150 AF patients are treated in EC/IRB approved clinical studies. These procedures lead to 100% success in delivering therapeutic modality.
Open surgeries are going down across the world and most procedures are now increasingly minimally invasive procedures. However, like interventional surgeons, the vascular surgeons often lack the skills for doing minimally invasive surgeries. Surgeons would be more effective with robotic procedures specifically around complex regions of the anatomy, like the aortic arch, common carotids etc. By pushing the catheters in these complex anatomical regions, these procedures can lead to major complications. With robotically steering the catheters, these complications can be avoided, said Macnamara. Additionally, with greater control at the tip, surgeons can make controlled lesions and stable sheath helps with the placement. With robotic procedures, the surgeons can also have more predictability and certainly with regards to time. Since surgeons have to be prepared for complications that can turn non robotic surgeries into open procedures, they have to block extra period of time. With robotic surgeries, they can adhere to the time schedule and thus it would enhance their efficiency.
Hansen Medical recently unveiled its new Magellan Robotic System that cannulates peripheral vessels and delivers simultaneous distal tip control of a catheter and a sheath from a centralized, remote workstation. Macnamara showed videos that indicate that this system gives the physician a right balance of flexibility with precision and control. Early adoption in Europe indicates great success in procedures like PAD, Splenic Aneurysm, Abdominal Aortic Aneurysms and so on. Clinical data suggests that with this system there is less vessel wall trauma to the patients, while the physicians experience greater success with higher efficiency. The next gen system will give independent control of both bends as research indicates that double bend will deliver huge benefits. Hansen Medicals’s technology is very exciting and we will stay tuned. The talk ended with highly interactive Q&A session.