US-based Hansen Medical has obtained the US Food and Drug Administration (FDA) clearance for its smaller diameter Magellan 6Fr robotic catheter, designed for peripheral vascular interventions.
The proprietary Magellan robotic catheter is designed to work in harmony with the Magellan robotic system to deliver control, precision and stability.
It has been designed to enable independent robotic control of two separate bend sites on a single catheter, compared with the current Magellan 9Fr robotic catheter, which is designed as a telescoping device with two, independently controlled robotic catheters.
The Magellan 6Fr is designed to deliver precise robotic navigation and control in a single, smaller diameter catheter.
It also enables use of the Magellan robotic system in smaller vessels in the peripheral vasculature and by physicians who may prefer a smaller diameter vessel insertion site.
The new catheter expands the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women’s health, and lower limb treatment.
The company said FDA clearance of the Magellan 6Fr robotic catheter triggers the mandatory exercise of $14m of Series A Warrants issued as part of the private placement of stock and warrants that was announced on 31 July 2013.
Hansen Medical CFO Peter J Mariani said: "This new catheter demonstrates our commitment to expanding the potential clinical applications of Magellan, providing further support to the compelling return on investment potential associated with a multi-disciplinary intravascular robotics programme."
The Magellan 6Fr is the latest addition to the growing family of catheters available for use with the Magellan Robotic System, which has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedure types in centres across the US and Europe.
The new lower profile robotic catheter allows robotic manipulation of standard guidewires and extends clinical benefits of intravascular robotics to broader set of patients, physicians and procedures.
Hansen Medical said it will begin a limited release of the device initially, and expects a more wide-scale release later this year.