SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

April 29, 2014 08:30 ET

Hansen Medical Announces World's First Clinical Cases With New Magellan™ 6Fr Robotic Catheter

Initial Clinical Experience to Be Presented at GEST 2014 Meeting, May 1 - 4, in San Francisco

MOUNTAIN VIEW, CA--(Marketwired - Apr 29, 2014) -   Hansen Medical, Inc. (NASDAQ: HNSN), announced today the successful completion of the world's first clinical procedures using the Magellan™ 6Fr Robotic Catheter. Professor Marc Sapoval, MD, PhD and Dr. Olivier Pellerin, MD, MSc treated three patients with the 6Fr catheter over the span of two days at Hôpital Européen Georges Pompidou (APHP). The cases included two Uterine Fibroid Embolizations and a Transarterial Chemoembolization (TACE) procedure for liver metastasis of colon cancer.

The three cases performed last week were the first in a 25 patient study at Pompidou Hospital (APHP) to assess the use of the new Magellan 6FR Robotic Catheter in a variety of embolization procedures.

The Magellan 6Fr Robotic Catheter is the latest addition to the growing family of catheters for use with the Magellan Robotic System. The 6Fr catheter's design provides for precise robotic navigation and control in a single 6Fr outer diameter catheter, and enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature. The Magellan 6Fr Robotic Catheter and accessories have received 510(k) clearance in the US, and are pending CE Mark. 

"We are pleased to have completed the world's first procedures with the Magellan 6Fr Catheter. With this study, we will explore the use of Intravascular Robotics in a wide variety of peripheral vascular embolization procedures, including therapies involving cancer treatment and women's and men's health," explained Professor Sapoval. "Navigation with this robotic catheter is very controlled, particularly in tortuous anatomy; and the Magellan Robotic System provided an extremely stable platform to support the precise and targeted delivery of therapeutic agents." 

"Today's announcement is an important milestone for Hansen Medical. The Magellan 6Fr Robotic Catheter will enable physicians to apply the benefits of robotic precision, control and procedural predictability to the treatment of many more vascular patients," said Chris Lowe, Interim CEO of Hansen Medical. "We are pleased to partner with Pompidou Hospital (APHP) as part of our shared commitment to improve the care of patients through the application of advanced technologies. These successful initial cases help to lay the foundation for the use of the Magellan system in embolization procedures." 

Hansen Medical to Present Magellan™ 6Fr Robotic Catheter at the Global Embolization Symposium and Technologies (GEST) 2014 U.S. Meeting 

Hansen will be conducting product demonstrations with the new Magellan 6Fr Robotic Catheter at the Global Embolization Symposium and Technologies (GEST) 2014 U.S. Meeting at the San Francisco Marriott Marquis May 1 - 4 at Booth 210. Prof Sapoval will discuss his initial clinical experiences with Magellan on Thursday, May 1 at 10:40am in a talk titled "Robotic Assisted Embolization: Early Human Experience." Prof Sapoval's presentation will be held during Parallel Session I: Navigation and New Imaging Tools in the Yerba Buena Ballroom.

Additionally, Olivier Pellerin, MD (Hôpital Pompidou) and Mohamad Hamady, MD (St. Mary's Hospital in London) will share their clinical experiences with the Magellan Robotic System at a breakfast symposium at 7:00am on Saturday, May 3 titled "Clinical Update on Robotic Assisted Embolization: What You Need to Know."  

About the Magellan™ Robotic System

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 improved 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 procedure types in centers across the U.S. and Europe. The Magellan Robotic System offers several important features including:

  • Provides improved 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 Robotic Catheter for independent, robotic control of the distal tip of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guidewires.
  • 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 guidewires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels. 

About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a 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, 9Fr Magellan™ Robotic Catheter, Magellan™ 6Fr Robotic Catheter, 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 Magellan 9Fr Robotic Catheter has undergone both CE marking and 510(k) clearance and is commercially available in the European Union, and the U.S. The Magellan 6Fr Robotic Catheter has undergone 510(k) clearance in the U.S. and is in limited release for the next several months in anticipation of more wide-scale commercially availability later in 2014. In the European Union, the Company's Sensei® X Robotic Catheter System and Artisan® and Artisan Extend® Control Catheters are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S., the Company's Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter 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 X Robotic Catheter System and Artisan and Artisan Extend Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at 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," "anticipates," 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 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: 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 uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on March 13, 2014 and the risks discussed in our other reports filed with the SEC. 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.

"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart Design)," "Heart Design (Logo)," "Sensei," "Lynx," "Artisan," "Instinctive Motion," "Fine Force Technology," "IntelliSense" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries.

Contact Information

  • Investor Contacts:
    Peter J. Mariani
    Chief Financial Officer
    Hansen Medical, Inc.
    650.404.5800

    Westwicke Partners, LLC.
    Mark Klausner or Mike Piccinino, CFA
    443.213.0500
    Email Contact