Navigation Links
Stereotaxis is Notified of the FDA Approval of an Additional Magnetic Irrigated Catheter
Date:1/12/2010

ST. LOUIS, Jan. 12 /PRNewswire-FirstCall/ -- Stereotaxis (Nasdaq: STXS) announced that the Celsius® RMT ThermoCool® catheter has been approved by the U.S. Food and Drug Administration for use with Stereotaxis' magnetic navigation system for the treatment of Type 1 atrial flutter.  The product is the fifth advanced ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for mapping and ablation.  

The Celsius® RMT ThermoCool® catheter was granted CE mark for distribution in the European Union in October 2009.

The Celsius® RMT and NaviStar® RMT catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe™ Magnetic Navigation System for optimal performance and highly precise catheter manipulation.

With the Celsius® RMT ThermoCool® catheter, the family of magnetic irrigated ablation catheters offers localized and non-localized technology. Localized catheters are used for more complex arrhythmias requiring 3D electro-anatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for a broader array of arrhythmias which can be treated using basic imaging and ECG recordings.

Separately, the FDA approved all of Biosense Webster's magnetic catheters for use with the magnetic field strength of 0.1 Tesla, an increase of 25 percent, which is now available in Stereotaxis navigation systems. In European clinical evaluations conducted in the fourth quarter of 2009, clinicians noted that the new field strength enhanced catheter navigation in difficult to reach locations; enhanced catheter stability, especially near the antrioventricular valves; and improved catheter contact along the isthmus region of both atria.

"The 25 percent improvement in field strength was immediately appreciated to improve navigation and stability for a wide range of procedure types with and without 3D mapping," said Dr. Tamas Szili-Torok, Clinical Head of Electrophysiology at Erasmus Medical Center in Rotterdam, The Netherlands. "We have implemented 0.1T as the default setting at our institution."

"These two new approvals provide clinicians in the U.S. with access to important new enhancements for magnetic navigation that we believe will enable clinical success in a broader range of arrhythmias," said Michael P. Kaminski, Stereotaxis President and CEO.

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.

About Forward Looking Statements

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company's products in the marketplace, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that we will recognize revenue related to our purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of our control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.

SOURCE Stereotaxis, Inc.

RELATED LINKS
http://www.stereotaxis.com

'/>"/>

SOURCE Stereotaxis, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Stereotaxis Receives Notice of European Approval of an Additional Magnetic Irrigated Catheter
2. Stereotaxis Announces Underwriters Exercise of Over-Allotment Option
3. Stereotaxis Announces Pricing of $26 Million Common Stock Offering
4. Stereotaxis Announces Public Offering of Common Stock
5. Stereotaxis Receives Commitment to Increase and Extend Its Credit Facility With Silicon Valley Bank
6. Stereotaxis Market Leadership Reinforced in Core Curriculum and Symposium Presentations at Heart Rhythm 2008
7. Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing
8. Boston Scientific Announces Japanese Approval for PROMUS(R) Everolimus-Eluting Coronary Stent System
9. WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor(TM) VAD
10. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
11. BASFs Aseptrol(R) S10 - Tab Receives EPA Approval For H1N1 Sanitization Label
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... TapImmune, Inc. (NASDAQ: TPIV), ... of innovative peptide and gene-based immunotherapeutics for the ... that it will participate in two upcoming Investor ... Wilson , Chairman and CEO of TapImmune, will ... pipeline and partnering opportunities for its proprietary PolyStart ...
(Date:3/22/2017)... , March 22, 2017 Hologic, Inc. ... has completed the acquisition of Cynosure, Inc., a leader ... share in cash. "We are pleased to ... working with Michael Davin and the entire ... large, rapidly growing medical aesthetics market," said Steve ...
(Date:3/22/2017)... 2017 TFS is pleased to announce the ... Tumaian , two global executive positions in Medical Affairs and Clinical ... Leadership Team and will report to Dr. Montse Barceló , ... ... 10 years of medical and scientific expertise gained across leading biopharmaceutical ...
Breaking Medicine Technology:
(Date:3/22/2017)... ... March 22, 2017 , ... Drs. Jennifer Houck, Lauren Smith, ... to accept new patients in need of skilled pediatric dentistry in Rock ... Care offers pediatric patients routine treatments, including cavities, sealants and fluoride applications, in a ...
(Date:3/22/2017)... , ... March 22, 2017 , ... ... core lab with extensive therapeutic experience and operational excellence in oncology clinical trials, ... clinical trial for the treatment of non-small cell lung cancer and small cell ...
(Date:3/22/2017)... ... March 22, 2017 , ... ... planning, and related services to communities across eastern Texas, is announcing a charity ... providing meals to hungry children and adults. , Consistently a top-rated nonprofit ...
(Date:3/22/2017)... ... ... Chris Humphrey Insurance Agency, a North Carolina firm offering asset protection services and ... initiating a charity event to raise support for five year old Dillyn, a young ... Friday evening in September 2014. At the time, Dillyn was only four years old, ...
(Date:3/22/2017)... ... March 22, 2017 , ... HumanHaus is proud to announce the launch ... broom was great when it was invented, but our customers today are busy, energetic, ... social young couple, the empty nesters and retired that want to travel. ...
Breaking Medicine News(10 mins):