Hansen Medical Announces Worldwide Survey of AF Ablation with Robotic Navigation Presented at American Heart Association Meeting
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Multi-Center Procedure Data Presented in Over 1700 Cases Using the Sensei(R) X Robotic Catheter System
Hansen Medical, UK Ltd, a subsidiary of Hansen Medical, Inc., , a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced a new multi-center worldwide survey evaluating the safety and efficacy of atrial fibrillation (AF) ablation by robotic navigation with the Sensei(R) Robotic Catheter System. The abstract was presented by Luigi Di Biase, MD, PhD, in a poster session (Poster # 16602) at the American Heart Association Scientific Sessions 2011 at the Orange County Convention Center in Orlando, Florida on November 14th, 2011.
The survey evaluated the safety and effectiveness of robotic navigation. The overall complication rate across the entire survey was a low 4.7%. After an average follow-up of 15 months, the success rate (defined as freedom from atrial tachyarrhythmia off antiarrhythmic drugs) of robotic procedures was slightly superior at 67% compared to that of manual procedures at 64%. Most compelling in the survey data are the benefits that robotic navigation demonstrated in both safety and efficacy as the electrophysiologist gained experience with the Sensei(R) Robotic Catheter System and improved their robotic techniques. The results of this survey, in addition to the other known benefits physicians, patients and payers receive from robotic navigation including less physician and patient radiation exposure, shorter procedure times and less physician fatigue, help establish the value of the Sensei(R) Robotic System for patients with cardiac arrhythmias.
"Our survey data demonstrates that the Sensei(R) Robotic Catheter System is a safe approach for the ablation of AF and has the potential to lead to superior success rates, especially as centers gain more experience with the System," said Dr. Di Biase.
The senior author of the abstract, Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., executive director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas said, "This is an important survey, and it demonstrates the safety and the efficacy of the Sensei(R) Robotic Catheter System."
"This comprehensive survey data as well as the numerous benefits of our flexible catheter robotic system, such as reduced radiation exposure, shorter procedure times and lower physician fatigue, demonstrate the value of the Sensei(R) Robotic Catheter as an alternative to manual procedures in arrhythmia patients," said Bruce Barclay, Hansen Medical's president and CEO. "In particular, the data showed the benefits derived in both safety and efficacy as operator experience with the System increases; and, importantly, points to the potential of replicating these successes in other centers through improved training and the sharing of best practices."
Mr. Barclay also noted that "the data reported in this survey includes procedures from the earliest clinical experiences with the system. Since initial launch in 2007, Hansen and our physician customers have gained significant experience and knowledge through the more than 7,000 patient procedures that have been performed with the system. During this time, physicians have developed advanced robotic techniques while the company has made several product design and feature enhancements including the Sensei(R)-X Robotic Catheter System with advanced catheter control and visualization features, improved mapping technology interfaces with our strategic partners - St. Jude, Phillips, GE and Siemens- and the company's advanced tactile feedback technology called IntelliSense(R) including Intellisense Vibe and Flex functionality. "
"Also during this time, the company has developed a world class education and training program designed to provide physicians and their staff with the ability to use the system with confidence and precision in a shorter period of time." Barclay concluded.
Under the survey, 1,728 patients with AF were treated with the Sensei(R) Robotic Catheter System at 12 different sites, including Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Methodist DeBakey Heart and Vascular Center, Houston, Texas and Christiaan Barnard Memorial Hospital, Cape Town, South Africa, in the US and internationally from June 2007 until December 2009. Patients with all types of AF were used in the study with 39% of the patients having either persistent (29%) or permanent (10%) AF, and the remaining (61%) with paroxysmal AF. Cappato's Worldwide Survey (2010) reporting on 16,309 AF patients was used for historical control of manual ablation results. Cappato's Worldwide Survey is conducted periodically by a group of prominent electrophysiologists and is considered a leading resource for ablation efficacy and complications by manual technique.
About the Sensei(R) X Robotic System and Artisan Control Catheter
In the Europe Union, the Sensei(R) X System and Artisan(R) Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF.
In the U.S., the Sensei(R) X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx(TM) Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire(TM) Electrophysiology catheters made by St. Jude Medical.
In the U.S., the safety and effectiveness of the Sensei(R) X Robotic Catheter System and Accessories for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established. Hansen Medical is conducting a 300 patient, multiple site IDE study in the United States to evaluate the performance of this device to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters (a) for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous catheters: the Polaris-Dx(TM) Steerable Diagnostic catheters made by Boston Scientific Corporation, and the Livewire(TM) Electrophysiology catheters made by St. Jude Medical, and (b) for manipulating the Navistar(TM) ThermoCool(TM) Diagnostic/Ablation catheters made by Biosense Webster for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional mapping systems. The study includes a seven-day follow-up for safety and a one-year follow-up for efficacy at intervals of 90, 180, and 365 days.
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) X Robotic Catheter System and Artisan(R) Control Catheter 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(R) 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(R) X System and Artisan(R) Control Catheter 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(R) X System and Artisan(R) Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx(R) Robotic Ablation Catheter is cleared for the treatment of AF. The Company's Magellan(TM) Robotic System, NorthStar(TM) Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone conformity assessment and CE marking and are commercially available in the European Union.
In the U.S., the Magellan(TM) Robotic System, the NorthStar(TM) Robotic Catheter and accessories are the subject of a pending 510(k) with the FDA and are not commercially available. Additional information can be found at http://www.hansenmedical.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "potential," "believes," goal," "estimate," and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such forward-looking statements include, but are not limited to, statements about the expected timing of regulatory submissions, approvals, clearances, and commercialization of our robotic systems and catheters, the market potential for our products, the expected sales and utilization levels for our products, and the potential benefits of our products in the treatment of patients. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include, among others: potential safety and regulatory issues that could delay, suspend or terminate clinical studies, regulatory approvals or sales; challenges in designing, engineering and manufacturing systems and catheters to function as intended; uncertain timelines, costs and results of clinical trials and the development of new products; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; and the effect of credit, financial and economic conditions on capital spending by our potential customers. These and other risks are described in greater detail under the heading "Risk Factors" contained in our Quarterly Report on Form 10-Q filed with the SEC on November 11, 2011 and our other periodic SEC filings. 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), Sensei, Artisan, Lynx and IntelliSense are registered trademarks, and Magellan, NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.
Contact:
Investor Contacts: Dr. Roland Peplinski, General Manager, EMEA,
AP & Canada, Hansen Medical, UK Ltd, +44-20-7393-1905. Toby Minton,
+44-(0)7921762293