Hansen Medical, headquartered in Mountain View, California

Mountain View, California

-Downtown:Mountain View has a pedestrian-friendly downtown centered on Castro Street. The downtown area consists of the seven blocks of Castro Street from the Downtown Mountain View Station transit center in the north to the intersection with El Camino Real in the south...

, designs and manufactures medical robotics for the accurate positioning and control of catheter-based technologies. The Company manufactures Sensei Robotic Catheter Systems

Sensei robotic catheter system

The Sensei X robotic catheter is a medical robot designed to enhance a physician’s ability to perform complex operations using a small flexible tube called a catheter. As open surgical procedures that require large incisions have given way to minimally invasive surgeries in which the surgeon gains...

, including next-generation Sensei X Robotic Catheter Systems, and Artisan Control Catheters. In May 2007, the Company obtained regulatory clearances to begin marketing the Sensei system in the United States and the European Union (EU). In September 2009, the Company received regulatory clearance to begin marketing the Sensei X. The company’s robotic system

Robotic ablation

Robotic ablation is the term used to describe catheter ablation of cardiac arrhythmias performed by an electrophysiologist using a robotic system. The robotic system consists of a ‘robotic sheath’ which manipulates cardiac catheters, operated remotely at a nearby control station. This page explains...

 enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart during complex cardiac arrhythmia procedures.

Hansen was founded by Dr. Frederic Moll, who currently serves as the company's Executive Chairman of the Board of Directors. Previously, he founded Intuitive Surgical, with which Hansen has a cross-licensing agreement. In June 2010, Hansen appointed veteran medical device industry executive Bruce J Barclay as president and chief executive officer, and a member of the Board of Directors. Prior to joining Hansen, Mr. Barclay was president and chief executive officer of SurModics, Inc.

Clinical Experience

Through March 2011, physicians have performed a cumulative total of more than 5,000 clinical cases using Hansen Medical’s Sensei system. Recent data from independent clinical studies has been encouraging. For example, a group of physicians associated with the Texas Cardiac Arrhythmia Institute published a study of 390 patients comparing success rates in those having catheter ablation of AF performed robotically to those performed manually over the same period in a single institution. The cohort was mixed and included patients with paroxysmal and persistent AF. Surgeons were able to isolate all pulmonary veins in 100% of patients in both groups. There was no difference in procedure time between manual and robotic ablation, although there was a reduction in fluoroscopy time (X-ray use) with robotic ablation. Success rates were: 85% with robotic ablation versus 81% if performed manually at 14 months. Additional clinical case studies from a U.S. community hospital was recently published in Cardiovascular Business showing the economic value possible with the Sensei System.

In May 2010, the company announced that it received conditional Investigational Device Exemption

Investigational Device Exemption

An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a...

 (IDE) approval from the U.S. FDA

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 authorizing a clinical trial to investigate use of the Sensei X Robotic Catheter System and the Artisan Control Catheter for treatment of AF. The first case in the ARTISAN AF Trial, a clinical trial using the Sensei X system for the treatment of AF, was completed May 11, 2010 by Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center. The Principal Investigator

Principal investigator

A principal investigator is the lead scientist or engineer for a particular well-defined science project, such as a laboratory study or clinical trial....

 of the trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive medical director for TCAI.

In September 2010, Hansen announced the first commercial sale of its Lynx Irrigated Ablation Catheter, a smaller robotic catheter with a flexible integrated ablation catheter designed to improve the treatment of cardiac arrhythmias. The rollout of the Lynx catheter in Europe marked an expansion from its core robotic navigation technology to include proprietary therapy delivery devices. In October 2010, Hansen announced the completion of the First in Man Study for the Company’s vascular robotic system, during which 20 peripheral endovascular procedures were successfully performed at a European clinical site. Hansen filed for 510(k) clearance to market the vascular robot system in the U.S. in April 2011 and expects the device to begin selling commercially in second half of 2011.

Partnerships

The Sensei platform is built upon an open architecture design that has helped Hansen Medical to establish partnership agreements with leading medical device companies. In May 2009, Hansen entered into a joint development agreement with Siemens Healthcare to co-develop integrated products designed to help simplify complex cardiac procedures for the diagnosis and treatment of heart arrhythmias. This agreement with Siemens

Siemens

Siemens may refer toSiemens, a German family name carried by generations of telecommunications industrialists, including:* Werner von Siemens , inventor, founder of Siemens AG...

 is the latest in a broad range of partnerships with leading companies that also include Philips Healthcare, GE Medical Systems

GE Healthcare

GE Healthcare is a division of GE Technology Infrastructure, which is itself a division of General Electric . It employs more than 46,000 people worldwide and is headquartered in Little Chalfont, Buckinghamshire, United Kingdom. GE Healthcare is the first GE business segment to be headquartered...

 and St. Jude Medical

St. Jude Medical

St. Jude Medical, Inc. is a $16 billion global medical device company, with headquarters in Little Canada, Minnesota, United States, a suburb of St. Paul. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. Its principal...

. In February 2011, Hansen signed a patent and technology license with Philips Healthcare allowing Phillips to develop and commercialize the non-robotic applications of Hansen Medical’s Fiber Optic Shape Sensing and Localization (FOSSL) technology.

History

• Founded – 2002
• IPO – November 2006
• FDA Clearance – May 2007
• CE Mark – May 2007
• First Customer Shipment – May 2007
• Hansen Medical Acquires AorTx - November 2007
• Raised $39.4 Million in Public Offering - April 2008
• FDA Clearance for the CoHesion 3D Visualization Module-July 2008
• Raised $35.1 Million in Public Offering - April 2009
• FDA Clearance for the "Artisan S Catheter" - May 2009
• Announced collaboration with GE Healthcare-May 2009
• FDA Clearance for next generation Sensei X-September 2009
• Investigation into Accounting Irregularities after an Anonymous Whistleblower Submits a Report - October 2009
• Raised $29.8 million in Public Offering – April 2010
• Announced co-development agreements with Siemens-May 2010
• First commercial sale of Lynx Robotic Ablation Catheter, first patients treated - September 2010
• First patients treated with new flexible robotic vascular system - October 2010
• Announced 510(k) filing with FDA on vascular robotic system and catheter - April 2011