Hansen Medical Submits 510(k) Application With U.S. FDA for Vascular Robotic System and Catheter
Published: Apr 11, 2011
MOUNTAIN VIEW, CA--(Marketwire - April 11, 2011) - 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 that it has submitted a 510(k) pre-market notification application with the U.S. Food and Drug Administration (FDA) on its Vascular Robotic System and Catheter.
The Hansen Medical Vascular Robotic System is based upon the leading flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, and which has been used in more than 5000 procedures in patients with cardiac arrhythmia.
"Delivering on this important milestone in the development of the Vascular Robotic System is a tribute to the hard work and success of the entire R&D, clinical and regulatory teams, as well as the multiple physicians that have helped support these development efforts," said Bruce Barclay, President and CEO of Hansen Medical. "Following our successful First in Man clinical study last year and this 510(k) submission, our goal of commercializing our Vascular Robotic System in the U.S. is that much closer to reality. This submission is a significant step toward delivering flexible robotics to the large and growing vascular market."
The Vascular Robotic System includes a number of key enhancements from the Sensei-X Robotic Catheter System to optimize the new System's use in vascular anatomy. First, the Vascular System allows for complete, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guide wires. Further, the catheter is expected to be available in multiple lengths and has a low profile with significant flexibility to be compatible with most 6F therapeutic catheters currently used today. Also, the System is designed to allow for sufficient extension inside the body to better access hard to reach peripheral anatomy. Finally, the System preserves the open architecture featured in the Sensei system to allow for the subsequent use with most therapeutic catheters on the market today. In 2010 the Company announced the completion of its First in Man clinical study in Europe during which 20 endovascular procedures were successfully performed with an earlier version of the Vascular Robotic System, demonstrating its potential to allow physicians to safely, effectively and efficiently treat peripheral vascular disease -- while exposing the patient, physician and hospital staff to less radiation.
In the US, the Vascular Robotic System is not available for sale pending clearance of the 510(k) submission, which is currently under review. In Europe, the System requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received.
The vascular market is large and rapidly growing, driven in large part by an aging population, the prevalence of diabetes and obesity and an increase in disease awareness. Of the more than 2 million vascular procedures done each year, approximately one-third to one-half of them are potentially addressable by Hansen Medical's Vascular Robotic System.
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® 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. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that 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 during EP procedures, such as guiding catheters in the treatment of AF. 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, and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. In the US, the Vascular Robotic System is not available for sale pending clearance of the 510(k) submission, which is currently under review. In Europe, the Vascular Robotic System requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received.
Additional information can be found at www.hansenmedical.com.
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 "goal," "potential," "expects," 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. Examples of such statements include statements about the potential benefits of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Annual Report on Form 10-K filed with the SEC on March 16, 2011. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), Lynx and Sensei are registered trademarks, and Artisan is a trademark, of Hansen Medical, Inc. in the United States and other countries.
Hansen Medical Contacts:
Allen & Caron Inc