Hansen Medical (NSDQ:HNSN) announced immediate commercial launch upon receiving FDA clearance for its Magellan robotic system and accessories for peripheral vascular interventions.
The system was cleared for providing navigation to anatomical targets and a conduit for manual device implantation while keeping physicians away from a potentially harmful radiation source.
"The global vascular surgery market is large and expanding rapidly, driven by long-term trend such as an aging population, the rising prevalence of type 2 diabetes and obesity and an increase in disease awareness," president & CEO Bruce Barclay said during a conference call. "Of the more than 3 million vascular procedures performed each year, approximately ⅓ to ½ of them are in the peripheral vasculature, which is the target market for the Magellan Robotic System."
The device provides physicians robotic control of catheter tips to navigate through a range of anatomies and lesions, according to a press release, and may be able to shorten procedure times and increase predictability in outcomes.
"The Magellan Robotic System results in a new standard for peripheral vascular intervention that has the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency," according to the company.
"We believe intravascular robotics has the potential to truly revolutionize the way endovascular procedures are performed," Barclay said. "From our perspective, innovation in this market has been limited, creating a significant unmet clinical need until now."
The Magellan system has applications for use by interventionalists, cardiologists, radiologists and endovascular surgeons, according to Hansen, and a large portion of the centers performing peripheral vascular interventions today have bought into Intuitive Surgical’s (NSDQ:ISRG) da Vinci robot-assisted surgery system.
"We have found that hospitals with prior experience with medical robotics are better able to understand the clinical and economic potential of additional robotics programs in their intuitions," marketing chief Joe Guido said during the call.
Wall Street was not enthused by the news, with HNSN shares dipping 3.5% to $2.21 as of about 1:45 p.m. today.