On June 4, 2012, global developer and manufacturer of robotics
Hansen Medical, Inc.
) announced the U.S. Food and Drug Association (FDA) 510(k)
clearance for its Magellan Robotic Systems, inclusive of the
catheter and related accessories. The commercialization of the
Magellan Robotic Systems will start with immediate effect in the
U.S. while a complete launch is expected later this year.
Hansen's Sensei and Magellan Robotic Systems are expected to be
the primary revenue drivers. The company's focus is on
commercialization strategy for the system. Positive clinical
experiences and data will hasten the adoption of the system in the
U.S. market and propel demand. Also worth mentioning in this
context is the initial interest exhibited by a number of key
hospitals in the U.S.
According to the company, the clearance marks a milestone in its
history. Management believes that the Magellan Robotic Systems has
latent qualities which will enable it to become a major growth
driver for the company. The clearance also represents a positive
step towards the introduction of intravascular robotics for
The company also believes that the system can present a unique
selling proposition to hospitals. It can help hospitals to achieve
a dual goal of offering quality patient care and improve
The Magellan Robotic Systems will improve navigation to
anatomical terminals in the peripheral vasculature. They also
provide a separate channel that will allow manual placement of
therapeutic devices. The Robotic Systems allow vascular surgeons to
perform faster and predictable acute procedures. It also prevents
physician fatigue by allowing those procedures to be performed from
a considerable distance. This also minimizes the radiation exposure
for the physician.
Statistics suggest that there is considerable scope for market
penetration as Magellan Robotic System can serve anywhere between
33% and 50% of the three million vascular procedures performed
globally each year. The market that the system will serve is
burgeoning due to aging population and high prevalence of obesity
and diabetes in the U.S. An increase in disease awareness is also
expected to bolster demand for the system.
Experts believe Magellan Robotic Systems is built on advanced
technology which will deliver important clinical benefits to
surgeons performing peripheral interventions. The system will
provide clinicians with independent robotic control of catheter
tips allowing easier navigation through anatomies and lesions. The
in-vivo and in-vitro clinical studies on animals also support the
findings that the system can increase efficiency and reduce time
taken for each procedure. It is also believed that the system might
enable an alternate means of patient treatment by allowing robotic
The Magellan Robotic System has the potential to revolutionize
peripheral vascular intervention because of improved lesion access,
precise control over distal tip, solid catheter stability and
procedural efficiency. Hansen has also initiated a commercial
launch for the system in the European Union where it received a CE
Mark in July 2011. Additionally, the system has been approved in
Australia while it is pending approval in Canada.
Hansen confronts a tough competitive landscape with large cap
market players like
Boston Scientific Corporation
Johnson and Johnson
). Hansen also faces competition from concerns such as
) in the U.S.
Hansen currently retains a Zacks #3 Rank, which translates into
a short-term Hold rating.
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