FDA clears the Magellan 6F robotic catheter


Hansen Medical has announced it has received US Food and Drug Administration (FDA) clearance for its smaller diameter Magellan 6 French robotic catheter for peripheral vascular interventions.

According to a press release, the Magellan 6 French robotic catheter is the latest addition to the growing family of catheters available for use with the Magellan robotic system, and features several important advances. Specifically, the Magellan 6 French robotic catheter features novel dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter, compared to the current Magellan 9 French robotic catheter which is designed as a telescoping device with two, independently controlled robotic catheters.

The 6 French catheter’s new design provides for precise robotic navigation and control in a single, smaller diameter 6 French outer diameter catheter, and 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.

“This is a major development for Hansen Medical and intravascular robotics,” says Barry Katzen, founder and medical director of Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami). “With this lower profile robotic catheter, we can now increase the number and types of procedures we perform with the Magellan robotic system. 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.”

Hansen Medical will begin a limited release of the Magellan 6 French robotic catheter, collecting clinical and procedure data over a broad set of cases over the next several months, and anticipates a more wide-scale release later in 2014, the press release adds.