Controlled Commercial Launch of Flexible, Irrigated Catheter Commences in Europe
MOUNTAIN VIEW, CA, Sep 01, 2010 (MARKETWIRE via COMTEX) --
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced the first sale of its Lynx(TM) Irrigated Ablation Catheter and the successful treatment of the first patients using the device. Physicians at John Radcliffe Hospital in Oxford, England performed the first clinical cases using the Lynx catheter to treat atrial fibrillation (AF), the world's most common cardiac arrhythmia that affects millions of people worldwide and is associated with increased long-term risk for severe conditions including stroke.
The rollout of the Lynx catheter in Europe marks an important next step in the company's strategy of expanding its target market from its core robotic navigation technology to include proprietary therapy delivery devices. The new Lynx catheter is a smaller* robotic catheter with a flexible integrated ablation catheter designed to improve the treatment of cardiac arrhythmias and drive adoption of Hansen's proprietary Sensei(R) X robotic technology into electrophysiology (EP) laboratories across Europe.
"We were able to perform ablation procedures for the treatment of AF while maintaining patient safety using the new Lynx catheter," said Dr. Kim Rajappan, Electrophysiologist, John Radcliffe Hospital. "The new Lynx catheter allowed me to use 30W of power to ablate where I would typically use 50W manually to create lesions with a lower risk to the patient of harmful steam pops. We love the new smaller size of the Lynx ablation catheter, and the increased flexibility and improved workflow. The catheter performance and stability compare well to Artisan(TM) catheter, and both are considerably better than the performance I get from manual ablation catheters."
Hansen Medical, which obtained CE Mark approval in the European Union for the Lynx catheter in July, will begin its limited rollout in this quarter and commence broader commercialization activities beginning in the fourth quarter.
"The success of Lynx in Europe and, ultimately, in other markets are central to our move into the higher revenue, higher margin opportunities provided by the sale of proprietary therapy systems," said Bruce J Barclay, president and CEO of Hansen Medical. "We are committed to providing technology that enables clinicians to offer better treatment options to their patients, while driving better economics for the healthcare system."
Barclay added that the Lynx irrigated catheter technology was developed to expand the treatment options for cardiac arrhythmias, including AF, through the use of a standard irrigated ablation in concert with robotic catheter control. "The early positive feedback from physicians once again demonstrates the promise our technology holds to broaden the utilization of robotics in EP procedures," Barclay said.
Hansen Medical's Lynx catheter is a small, flexible irrigated ablation catheter created to offer stability during the treatment of AF and other atrial EP disorders. The new catheter is supported by the company's Sensei X Robotic Catheter system, and it leverages the navigation capability of the Artisan family of catheters, but in a smaller and more flexible integrated profile. Offering a seven French irrigated ablation tip with an industry standard sized sheath, the Lynx catheter has six degrees of freedom that facilitates placement in difficult to reach locations within the heart.
Professor Richard Schilling, M.B., B.S., F.R.C.P., M.D., Consultant Cardiologist at London Bridge Hospital (UK), remarked, "The Lynx irrigated ablation catheter is an ideal catheter for the treatment of paroxysmal AF as it appears to have greater flexibility and range of movement than other commercially available ablation catheters."
The Lynx catheter is compatible with the industry's standard generators and irrigation pumps, including the Stockert(TM) 70 or Stockert(TM) EP Shuttle RF Generators and the CoolFlow(TM) 70 Pump. The Sensei X system is the company's next generation flexible robotic platform that uses robotic catheter technology to provide stable and predictable control of catheter movement during interventional procedures. Data from independent clinical studies show that use of the Sensei platform in procedures for AF and other abnormal heart rhythms significantly reduced patients' exposure to harmful cancer causing radiation.
*Smaller outer diameter as compared to the Artisan control catheter
About Hansen Medical, Inc. Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The company's Sensei(R) system and its Sensei X Robotic Catheter System were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. The flexible robotic platform is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The safety and effectiveness of the Sensei and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei and the Sensei X systems are cleared for use during EP procedures, such as guiding catheters in the treatment of AF. Additional information can be found at www.hansenmedical.com.
Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "believes," "goal," "estimate," and similar words. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995.
Hansen Medical, Heart Design, Hansen Medical & Heart Design, and Sensei are registered trademarks, and Artisan, and Lynx, are trademarks of Hansen Medical, Inc. in the United States and other countries. Stockert and CoolFlow are trademarks of Biosense Webster.
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SOURCE: Hansen Medical, Inc.