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:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Millions of individuals in the United States and Canada wear eyeglasses. Once considered to ... correct vision and make a fashion statement. Even celebrities use glasses as a way ...
(Date:6/26/2016)... Viejo, California (PRWEB) , ... June 26, 2016 , ... ... Final Cut Pro X. , "Film editors can give their videos a whole new ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels contains ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... ... of Bruton Memorial Library on June 21 due to a possible lice infestation, as reported ... head lice: the parasite’s ability to live away from a human host, and to infest ... in the event that lice have simply gotten out of control. , As lice are ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
(Date:6/23/2016)... Pa. , June 23, 2016 The ... in an outpatient dialysis facility.  Treatments are usually 3 ... 6 hours per visit, including travel time, equipment preparation ... a patient, but especially grueling for patients who are ... of a skilled nursing and rehabilitation centers for some ...
Breaking Medicine Technology: