MOUNTAIN VIEW, CA — (Marketwired) — 01/14/16 — Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today provided an update of key corporate initiatives which, if successful, will expand the utility and regulatory labeling of the Sensei® and Magellan product lines:
This study is a prospective, single arm study of the Hansen Sensei System for introducing and positioning RF ablation catheters in subjects with paroxysmal atrial fibrillation (PAF). As of January 8, 2016: 148 subjects have been enrolled and treated, and 2 cases are pending to complete full enrollment of 150. In preparation for future commercialization, the initial PMA shell was submitted to FDA, paving the regulatory pathway. This clinical trial includes a Bayesian adaptive design, which permits an interim analysis and incorporates stopping rules to evaluate early success or futility.
“The upcoming interim analysis of the ARTISAN study has been long-awaited by physicians and patients, and we look forward to sharing the results promptly and hope it will be informative about the role of robotics in the treatment of PAF,” said Cary Vance, President and CEO of Hansen Medical.
Additional key details for the ARTISAN IDE Study are described below; the ClinicalTrials.gov Identifier for this trial is NCT01122173:
Primary Safety Endpoint: The incidence of Major Complications, including the early onset (within 7 days of the ablation procedure) predefined complications; and the incidence of esophageal injury or pulmonary vein stenosis through day 180.
Hypothesis: The study is designed to determine if the Major Complication rate meets the pre-established target performance goal (TPG) of 16%.
Primary Key Effectiveness Endpoint: Chronic Success: Freedom from symptomatic atrial fibrillation, atrial flutter, and atrial tachycardia episodes from days 91-365 after the initial ablation procedure, as documented by event recording, ECGs and Holter monitoring.
Hypothesis: The study is designed to determine if the effectiveness rate meets the pre-established target performance goal (TPG) of 54%.
Hansen Medical has begun the preparatory process to submit the 510k to FDA for a neurological indication for the Magellan Robotic System. The company anticipates submitting a 510k to the FDA in Q1 2016 for this expanded indication.
“The capabilities of our robotic catheters are opening up new opportunities for physicians”, said Francis McNamara, VP, Research and Development at Hansen Medical, “As we expand our suite of advanced micro catheters, we believe there are many opportunities to improve patient outcomes.”
: Hansen Medical shipped 4 robotic systems and 1 Mobility Package in Q4, 2015, including units to 2 U.S. Hospitals, a system in partnership with Medtronic to Maastricht University Medical Center in The Netherlands, and systems to AB Medica in Italy and to AFYA Medical Group in Saudi Arabia.
Hansen Medical–s Magellan Robotic System is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver predictability, control and catheter stability to endovascular procedures. Since its commercial introduction in the U.S. and Europe, the Magellan Robotic System has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedures globally. The Magellan Robotic System offers several important features including:
Provides predictability, control and catheter stability as a physician navigates a patient–s peripheral vasculature and then provides a conduit for manual treatment of vascular disease with standard therapeutic devices.
Is designed to enable more predictable procedure times and increased case throughput potentially allowing hospitals to improve utilization within their vascular business line.
Employs an open architecture designed to allow for the subsequent use of many therapeutic devices on the market today.
Is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures.
The Magellan 9Fr and 10Fr Robotic Catheters allow for independent, robotic control of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guide wires.
The Magellan 6Fr Robotic Catheter allows for independent robotic control of two separate bend sites on a single catheter, as well as robotic manipulation of standard guide wires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels.
The Sensei Robotic System combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in thousands of patients, and is powered by a robotically controlled arm that allows for catheter navigation, stability and positioning within the patient–s heart atria. The Sensei Robotic System, control catheters 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 specified percutaneous mapping catheters. The Sensei Robotic System is powered by a robotically controlled arm that allows for catheter navigation and stability. The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in Intravascular Robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company–s Magellan Robotic System, Magellan Robotic Catheters, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Company–s mission is to enable cardiac arrhythmia and endovascular procedures and to improve patient outcomes through the use of intravascular robotics. Additional information can be found at .
“Hansen Medical,” “Hansen Medical (with Heart Design),” and “Heart Design (Logo)” are registered trademarks, and “Magellan” and “Hansen Medical Magellan” are trademarks of Hansen Medical, Inc. in the U.S. and other countries. All other trademarks are the property of their respective owners.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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,” “anticipates,” and other 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 statements include statements regarding the potential benefits of our robotic systems for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and economic conditions on capital spending by our potential customers; the rate of adoption of our systems and the rate of use of our catheters; our ability to manage expenses and cash flow, and obtain adequate financing; and other risks more fully described in the “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2014, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. 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.
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