Navigation Links
Stereotaxis Announces FDA Approval of the NAVISTAR(R) RMT THERMOCOOL(R) Catheter
Date:2/27/2009

ST. LOUIS, Feb. 27 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. (Nasdaq: STXS) announced today that the U.S. Food and Drug Administration approved for marketing the NAVISTAR(R) RMT THERMOCOOL(R) Catheter, which is manufactured by Biosense Webster, Inc, a Johnson & Johnson company. The NAVISTAR(R) RMT THERMOCOOL(R) Catheter is used with Stereotaxis' NIOBE(R) Remote Magnetic Navigation System for mapping and radiofrequency (RF) ablation to treat irregular heartbeats, or cardiac arrhythmias. Stereotaxis expects that shipments of the catheter to customers will begin within the next few weeks.

"The magnetic irrigated catheter's approval is the tipping point for Stereotaxis technology," said Mike Kaminski, Stereotaxis President and CEO. "Together with the Remote Magnetic Navigation System and our recently introduced software platform, Navigant 3.0 with QuikCAS(TM), the magnetic irrigated catheter represents a quantum leap forward for remote ablation procedures and has demonstrated the potential to establish a new standard of care for treating cardiac arrhythmias in all chambers of the heart.

"This important milestone will provide our customers an expansion of system capabilities through the availability of a broad set of magnetic devices which address the many needs of patients in all chambers of the heart," added Mr. Kaminski. "We are confident that this product introduction will be transformative for our company."

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 and elsewhere.

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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Stereotaxis Reports Fourth Quarter 2008 Financial Results
2. Stereotaxis Annouces First CTO Crossing Procedure With RF PowerAssert(TM) Magnetic Guidewire
3. Stereotaxis to Raise $20 Million in Registered Direct Offering of Common Stock and Warrants
4. Stereotaxis Reports Third Quarter 2008 Financial Results
5. Stereotaxis Announces New Management Appointment
6. Stereotaxis Reports Record Second Quarter Revenue
7. Stereotaxis Announces Second Quarter 2008 Earnings Release Date and Conference Call
8. Stereotaxis Magnetic Navigation System Used to Successfully Treat an Inoperable Congenital Heart Defect in a 10-Year Old Patient
9. Stereotaxis Reports Record First Quarter Orders
10. Stereotaxis to Present at the Deutsche Bank 33rd Annual Health Care Conference
11. Stereotaxis Niobe Magnetic Navigation Systems Perform Approximately 15,000 Cases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... ... of our nation’s productivity, stability, even security. Most importantly, employees are the single ... Then why are American workers so unhappy? , Just under half of American ...
(Date:4/29/2016)... ... April 29, 2016 , ... Conditions were ideal for Global ... Park on Sunday, with sunny skies, a light breeze and temperatures in the 60s. ... , The 5k Run and Walk and 1-mile walk were held to increase ...
(Date:4/29/2016)... , ... April 29, 2016 , ... Spine Team Texas, ... is proud to announce one of their physicians has been invited to be a ... (Texas ACOFP) Family Practice Review conference on April 30, 2016. , Dr. R. ...
(Date:4/29/2016)... , ... April 29, 2016 , ... ... of patented products, announces the Gyrociser, an exercise invention which aids in proper ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Globalization ...
(Date:4/29/2016)... ... ... Dr. Robert Mondavi, one of the dentists in Torrance , is now ... as more patients are discovering the many different ways they can change and improve ... to them and which ones might work for their smiles. , “One of ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... , Schweiz, April 27, 2016 ... Sachs CEO Forums in Zürich gab Strekin ... führenden Wirkstoffkandidaten STR001 zur Erhaltung des Resthörvermögens ... wurde, bekannt. Für die umfassende Phase-II-Doppelblindstudie mit ... Frankreich angeworben. STR001 wird während der Operation ...
(Date:4/27/2016)... 27, 2016   Zillion Group today ... technology platform, which specializes in live video consultation. ... digital products, Zillion enables companies to realize the ... to take control of their health. ... – including one-to-one, group and webcast scheduled or ...
(Date:4/27/2016)... NEW YORK , April 27, 2016 /PRNewswire/ ... OASM ), a developer of a new ... today announced positive overall survival results for Paclical/Apealea ... total of 789 patients with epithelial ovarian cancer. ... treatment groups: Paclical/Apealea in combination with carboplatin versus ...
Breaking Medicine Technology: