Hansen Medical

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Hansen Medical, Inc.
Traded as NASDAQHNSN
Industry Medical Appliances & Equipment
Founded 2002 (2002)
Founder(s) Dr. Frederic Moll
Headquarters Mountain View, California, U.S.
Products Sensei robotic catheter system
Website www.hansenmedical.com

Hansen Medical, headquartered in Mountain View, California, designs and manufactures medical robotics for the accurate positioning and control of catheter-based technologies. The Company manufactures Sensei Robotic Catheter Systems, including next-generation Sensei X Robotic Catheter Systems, and Artisan Control Catheters.[1] 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 enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart during complex cardiac arrhythmia procedures.[2]

Hansen was founded by Dr. Frederic Moll, Robert Younge, and Dan Wallace. Previously, Robert Younge and Fred Moll founded Intuitive Surgical, together with John Freund. Hansen has a cross-licensing agreement with Intuitive Surgical. 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.[3]

Clinical Experience[edit]

Through March 2011, physicians have performed a cumulative total of more than 5,000 clinical cases using Hansen Medical’s Sensei system.[4] 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 atrial fibrillation performed robotically to those performed manually over the same period in a single institution.[5] 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.[6]

In May 2010, the company announced that it received conditional Investigational Device Exemption (IDE) approval from the U.S. FDA 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 of the trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive medical director for TCAI.[7]

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.[8] 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.[9]

Partnerships[edit]

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.[10] This agreement with Siemens is the latest in a broad range of partnerships with leading companies that also include Philips Healthcare, GE Medical Systems and St. Jude Medical.[11] 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.[12]

History[edit]

  • Founded – 2002[13]
  • 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[14]
  • 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 [15]
  • 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

References[edit]

  1. ^ Hansen Medical Products
  2. ^ "Hansen Medical Unveils Next Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart". MarketWire. 2009-09-15. Retrieved 13 August 2010. 
  3. ^ "Hansen Medical (HNSN) Names Bruce J. Barclay as CEO". StreetInsider. 2010-06-01. Retrieved 13 August 2010. 
  4. ^ "Hansen Medical, Inc. Q4 2009 Earnings Call Transcript". SeekingAlpha. 2010-02-23. Retrieved 13 August 2010. 
  5. ^ Di Biase L; Wang Y; Horton R; Gallinghouse GJ; Mohanty P; Sanchez J; Patel D; Canby R; Price LD; Zagrodzky JD; Bailey S; Burkhardt JD; Natale A (2009-07-28). "Ablation of Atrial Fibrillation Utilizing Robotic Catheter Navigation in Comparison to Manual Navigation and Ablation: Single-Center Experience". J Cardiovasc Electrophysiol. 
  6. ^ C.P. Kaiser (2011-04-12). "Texas Health Arlington Memorial Hospital: Becoming a Center of Excellence". Cardiovascular Business. Retrieved 2011-06-01. 
  7. ^ "Hansen Medical Announces FDA Conditional IDE Approval for Evaluating Sensei X Robotic Catheter System for Treatment of AF". EP Lab Digest. 2010-06-10. Retrieved 14 August 2010. 
  8. ^ "Hansen Medical Announces First Sale of Lynx(TM) Irrigated Ablation Catheter, First Patients Treated Controlled Commercial Launch of Flexible, Irrigated Catheter Commences in Europe" (Press release). Hansen Medical. 2010-09-01. 
  9. ^ "Hansen Medical Announces First Patients Successfully Treated With New Flexible Catheter Vascular Robotic System Key Milestone Toward Expected Commercial Launch in Mid-2011" (Press release). Hansen Medical. 2010-10-04. 
  10. ^ "Hansen Medical, Siemens Healthcare To Co-develop Products To Treat Irregular Heartbeats - Update". RTTNews. 2010-05-03. Retrieved 13 August 2010. 
  11. ^ "Hansen Medical, Inc. Earnings Conference Call (Q2 2010)". Yahoo! Finance. 2010-08-06. Retrieved 13 August 2010. 
  12. ^ "Hansen Medical and Philips Enter Agreements for the Development of Non-Robotic Applications of Fiber Optic Shape Sensing and Localization Technology" (Press release). Hansen Medical. 2011-02-03. Retrieved 2011-06-02. 
  13. ^ "Company Profile". Hansen Medical. Retrieved 2011-06-01. 
  14. ^ http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090365.pdf
  15. ^ http://finance.yahoo.com/news/Hansen-Medical-Announces-Need-iw-3897606488.html?x=0&.v=1