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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... established the certification process to promote standards of excellence for the field of ... scheduled for March 22 – 25, 2018 in Orlando, Florida at the Omni ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of ... ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership in ... It also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... ... , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a ... centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... EXTON, Pa. , Oct. 12, 2017 ... global leader in innovative solutions for injectable drug administration, ... results before the market opens on Thursday, October 26, ... discuss the results and business expectations at 9:00 a.m. ... 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is ...
(Date:10/11/2017)... 11, 2017  True Health, a leader in ... effort during National Breast Cancer Awareness month to ... Research recently ... that more than 10 million American women are ... BRCA1 or BRCA2 and have not had testing. These ...
(Date:10/10/2017)... 2017   West Pharmaceutical Services, Inc. (NYSE: ... drug administration, today shared the results of a study ... the intradermal administration of polio vaccines. The study results ... May 2017 by Dr. Ondrej Mach , Clinical ... Organization (WHO), and recently published in the journal ...
Breaking Medicine Technology: