Hansen Medical, a global leader in intravascular robotics and the developer of robotic technology for accurate 3D control of catheter movement, have received 510(k) clearance from the US Food and Drug Administration (FDA) for its Magellan Robotic System for use in peripheral vascular interventions.

The system, which received European approval in 2011, will provide interventional cardiologists and vascular surgeons a platform allowing them to perform fast and predictable vascular procedures. It also allows physicians to be seated away from the radiation source during procedures, and prevents them from standing on their feet for long periods of time.

The Magellan system is designed to facilitate navigation to anatomical targets in the peripheral vascular system and provide a conduit for the manual placement of therapeutic catheters. This should shorten the learning curve for younger physicians who are being trained in endovascular procedures. The Magellan Robotics system is an open system and is compatible with most therapeutic catheters, allowing doctors to continue using the catheters they are comfortable with without any switching costs.

While the clearance from the FDA is a positive sign for the company, Hansen Medical could still have a challenging road ahead for its Magellan robot. While the robot intends to provide surgeons and interventionalists a platform allowing them to perform peripheral vascular procedures faster, skilled specialists can already perform these procedures in a timely fashion, and the question will be whether hospitals are willing to shell out the $1.49 million price tag for the instrument. However, the Magellan Robotics Systems may have an attractive value proposition if it can further shorten procedure times and reduce patient complication rates. "To remain competitive in the markets they serve, hospitals need to become more efficient, while also increasing their patient capacity. The Magellan Robotic System has the potential to help hospitals accomplish both of these goals," said Hansen Medical CEO Bruce Barclay. The clinical and the economic benefit of the Magellan System may be significant, as quite often multiple catheters and guide wires will be used during a single case. Using fewer of these devices will save hospitals money over time, while the system’s accuracy may lead to fewer traumas to patient vessels, enabling quicker recovery times.

Hansen Medical stands to benefit if their Magellan Robotic System can show an economic benefit to hospitals and a clinical benefit to patients. GlobalData estimates the peripheral vascular device market will grow to $5.2 billion by 2018, as the aging population, growing prevalence of diabetes and obesity, and increase in disease awareness are set to drive up cases of peripheral vascular disease. Hansen will have to start marketing the Magellan Robotic system in a tough economic climate, as the ongoing economic uncertainty may prevent hospitals from large capital expenditures in the near term future. However, Hansen Medical plans to roll out a soft launch of the Magellan System to select hospitals in order to accumulate data to show the benefit of using the system in peripheral interventions. “This focused and controlled commercial launch should enable us to generate positive clinical experiences and data to drive both interest and adoption among other physicians and hospitals in the large and rapidly expanding US peripheral vascular market, and will be followed later this year with full launch activities," said Barclay.