St. Jude Medical Announces CE Mark Approval of ViewFlex Xtra ICE Catheter
New catheter provides real-time, high-resolution ultrasound images of blood flow and cardiac anatomy when paired with the ViewMate Z Intracardiac Ultrasound Console
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced European CE Mark approval of its ViewFlex™ Xtra Intracardiac Echocardiography (ICE) Catheter. Designed for control and maneuverability during complex cardiac ablation procedures, the technology will be on display at the eighteenth annual Boston AF Symposium.
ViewFlex(TM) Xtra ICE Catheter (Photo: St. Jude Medical)
Offering a four-way directional tip, the ViewFlex Xtra ICE Catheter also has the added benefit of auto-lock steering, which allows for single-handed operation of the catheter to minimize repositioning. Paired with the ViewMate™ Z Intracardiac Ultrasound Console, the integrated products help clinicians better visualize, in real-time, a patient's cardiac anatomy, including internal structure of the heart and blood flow direction. The high-resolution images and vivid color displays provide improved guidance for physicians.
"This technology offers crisp, clear visualization of the patient's anatomy to help guide us in performing a variety of procedures such as radiofrequency ablation to treat irregular heart rhythms," said Dhanunjaya Lakkireddy, M.D., cardiologist and professor of internal medicine at the University of Kansas Hospital in Kansas City, Kan. "The ViewFlex ICE Catheter's easy to use, one-handed operation allows for a more efficient procedure."
The catheter is inserted in the body through a small incision in the femoral vein (located in the leg) and guided to the heart. Featuring an ergonomic handle, the ViewFlex Xtra ICE Catheter offers improved maneuverability to enhance procedural workflow.
"The combination of the ViewFlex Xtra ICE Catheter and ViewMate Z Intracardiac Ultrasound Console in an integrated EP Lab not only yields exceptional images, but more importantly allows physicians to focus on the patient and less on catheter manipulation," said Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division at St. Jude Medical.
The ViewFlex Xtra ICE Catheter received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2012.
To learn more about the ViewFlex Xtra ICE Catheter and see a live demonstration at Boston AF, visit St. Jude Medical at booth 319 in the Seaport Hotel & Conference Center at the World Trade Center between the hours of 9 a.m. and 4:30 p.m.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
KEYWORDS: United States Europe North America Massachusetts Minnesota
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