Welcome!

News Feed Item

Hansen Medical Submits 510(k) Application With U.S. FDA for Vascular Robotic System and Catheter

System Designed to Access the Larger Vascular Market

MOUNTAIN VIEW, CA -- (Marketwire) -- 04/11/11 -- 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.

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 "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:

Peter Osborne
Interim CFO
Hansen Medical
650.404.5800

Matt Clawson
Allen & Caron Inc
949.474.4300
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
As many know, the first generation of Cloud Management Platform (CMP) solutions were designed for managing virtual infrastructure (IaaS) and traditional applications. But that's no longer enough to satisfy evolving and complex business requirements. In his session at 21st Cloud Expo, Scott Davis, Embotics CTO, explored how next-generation CMPs ensure organizations can manage cloud-native and microservice-based application architectures, while also facilitating agile DevOps methodology. He expla...
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices t...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
DevOps promotes continuous improvement through a culture of collaboration. But in real terms, how do you: Integrate activities across diverse teams and services? Make objective decisions with system-wide visibility? Use feedback loops to enable learning and improvement? With technology insights and real-world examples, in his general session at @DevOpsSummit, at 21st Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, explored how leading organizations use data-driven DevOps to clos...
"I focus on what we are calling CAST Highlight, which is our SaaS application portfolio analysis tool. It is an extremely lightweight tool that can integrate with pretty much any build process right now," explained Andrew Siegmund, Application Migration Specialist for CAST, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, discussed how they built...
The dynamic nature of the cloud means that change is a constant when it comes to modern cloud-based infrastructure. Delivering modern applications to end users, therefore, is a constantly shifting challenge. Delivery automation helps IT Ops teams ensure that apps are providing an optimal end user experience over hybrid-cloud and multi-cloud environments, no matter what the current state of the infrastructure is. To employ a delivery automation strategy that reflects your business rules, making r...
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...
Digital transformation is about embracing digital technologies into a company's culture to better connect with its customers, automate processes, create better tools, enter new markets, etc. Such a transformation requires continuous orchestration across teams and an environment based on open collaboration and daily experiments. In his session at 21st Cloud Expo, Alex Casalboni, Technical (Cloud) Evangelist at Cloud Academy, explored and discussed the most urgent unsolved challenges to achieve f...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, examined the regulations and provided insight on how it affects technology, challenges the established rules and will usher in new levels of diligence arou...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...