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FDA Clears Hansen's Robotic System

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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 vascular procedures.

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 organizational efficiency.

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 endovascular interventions.

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 (BSX - Free Report) and Johnson and Johnson (JNJ - Free Report) . Hansen also faces competition from concerns such as Stereotaxis Inc. in the U.S.

Hansen currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.

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