14.01.2010 12:58:00
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St. Jude Medical Showcases Latest Products at Boston Atrial Fibrillation Symposium 2010
St. Jude Medical, Inc. (NYSE:STJ) today announced it will display and demonstrate products and technologies from the company’s arrhythmia management portfolio at the 15th annual Boston Atrial Fibrillation (BAF) Symposium. The featured products reflect the company’s continued commitment to the treatment of abnormal heart rhythms, including Atrial Fibrillation (AF).
St. Jude Medical will feature products and technologies that aid physicians in the diagnosis and treatment of cardiac arrhythmias and cardiovascular disease in the U.S. and around the globe. Physicians can also get hands-on experience with several of the company’s latest products by visiting the stations at the company’s booths.
"St. Jude Medical is committed to developing curative solutions which help treat atrial fibrillation and other debilitating cardiac arrhythmias,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. "We are designing innovative products which help physicians to achieve safe, reproducible results and improve patient outcomes for their ablation procedures as well as sponsoring research that addresses important clinical questions facing the medical community.”
St. Jude Medical is a leader in the worldwide cardiac ablation and AF markets, which are estimated at about $2 billion annually. In 2009, the company added several key products to its broad portfolio:
EnSite™ Velocity System: The next-generation of the industry-leading EnSite™ System is designed to help physicians more efficiently diagnose and guide therapy to treat abnormal heart rhythms. The EnSite Velocity System creates a three-dimensional (3D) model of the patient’s heart, allowing physicians to visualize their patient’s unique anatomy with great detail. Physicians can then quickly locate the source of the arrhythmia and formulate a treatment strategy. The new platform is customizable, providing the flexibility to better integrate current and future technology. The EnSite Velocity has received FDA clearance and CE Mark approval.
Catheters: St. Jude Medical introduced two new catheters designed to quickly and efficiently assess cardiac arrhythmias and a circular mapping catheter with the industry’s smallest turning radius.
Reflexion™ High Density Mapping Catheter: The first high-density mapping catheter in the U.S. from St. Jude Medical leverages the capabilities of the EnSite™ System to quickly create highly detailed anatomical and electrical maps of the heart. These maps help physicians in the diagnosis and treatment of complex arrhythmias. The catheter’s efficiency in gathering information, versatility and predictable electrode positioning may reduce the number of products and the amount of time needed for a procedure. It also has CE Mark approval.
Inquiry™ AFocus II Catheter: The new double-loop catheter marks St. Jude Medical’s entry into the growing high-density mapping catheter market in Europe. The high concentration of electrodes and the double loop is designed to increase the catheter’s endocardial tissue contact, and is intended to help physicians collect more information in a given area and potentially aid in a more accurate diagnosis of complex arrhythmias. The catheter, which also expands the capabilities of the EnSite System, may help to reduce the number of products and the amount of time needed for a given procedure by providing an anatomical model of the heart with just one catheter. The catheter has CE Mark approval.
Reflexion™ Spiral 5 F DuoDeca Variable Radius Catheter: The next-generation circular atrial mapping catheter is flexible and highly maneuverable, which helps physicians to better access the areas of the heart necessary to identify the heart’s electrical signals. At 51 mm, the DuoDeca has smallest turning radius found in a catheter, which aids navigation in smaller and tighter spaces in the atria. The catheter has FDA clearance and CE Mark approval.
Agilis™ Specialty Introducers: St. Jude Medical has also expanded its portfolio of steerable access products, building on its leading Agilis™ NxT family of products designed to help diagnose and treat specific cardiac arrhythmias. Physicians can visit the Agilis Introducer Station to navigate a sample left atrium using the Agilis NxT family of products, including the new Agilis NxT Large Curl Steerable Introducer in different sizes and the ACross™ Transseptal Access System.
Epicardial Catheter System: The Epicardial Catheter System features the Agilis™ EPI Steerable Introducer and Response™ Electrophysiology Catheter. It is the only catheter system cleared for use in an epicardial application, and was designed to help physicians gain access to the outside surface of patients’ hearts. The Epicardial Agilis™ EPI Steerable Introducer allows expanded access in hard-to-reach areas of the epicardial space while providing needed stability for a wide range of catheters and procedures. The catheter system has FDA clearance.
Agilis™ NxT Large Curl Steerable Introducer: The introducer was designed to provide physicians with expanded access for further reach in the left side of the cardiac anatomy, while providing stability for a wide range of EP catheters for mapping and ablation. The bi-directional, steerable sheath offers access to areas that may have been previously out of reach for patients with large or remodeled hearts. The introducer has FDA clearance and CE Mark approval.
Cardiac Rhythm Management Products: St. Jude Medical is committed to developing smarter, more active products which reduce patient risk and improve physician control during procedures. The company’s comprehensive portfolio of wireless CRM technologies is changing the way that physicians view connectivity and allows them to more efficiently manage their patients.
Accent™ RF and Anthem™ RF Pacemakers: The market’s first completely wireless pacemakers from implant through follow-up, the Accent RF pacemaker and Anthem RF cardiac resynchronization therapy pacemaker (CRT-P) enable physicians to wirelessly program the devices, transmit comprehensive diagnostic data and be alerted to important changes in the device or with the patient’s condition through the Merlin.net™ PCN (Patient Care Network). The Accent RF and Anthem RF pacemakers have received FDA and CE Mark approval.
Merlin.net® Patient Care Network: A secure, Internet-based remote care system for patients with implanted medical devices that gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote transmissions sent from a patient’s home. The most recently launched version of Merlin.net PCN, version 4.0, provides an additional feature called DirectTrend™ Viewer, which graphically displays patient trends and disease progression. This allows physicians to more effectively and efficiently manage patients through interactive views of patient data over time. Version 4.0 of the Merlin.net PCN has received FDA and CE Mark approval.
Durata™ Defibrillation Lead with SJ4 Connector: The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required at least three separate connections and as many as eight set screws. The reduced number of lead connections may also lessen the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device. The Durata Defibrillation Lead with SJ4 Connector has received FDA and CE Mark approval.
Other products on display which aid physicians in managing cardiac arrhythmias include:
Visualizing & Recording: EnSite Array™ Catheter, EP-WorkMate™ Recording System, and ViewMate™ II Ultrasound System with ViewFlex™ Catheter
Access & Diagnosis: ACross™ Transseptal Access System, Swartz™ Braided Transseptal Guiding Introducers, Ultimum™ Introducers, FastCath™ Introducers, Livewire™ and Inquiry™ Steerable Electrophysiology Catheters, TigerWire™ Guidewire, HydroSteer™ Guidewire, and Venture™ Guidewires
Ablation Catheters: Safire™ Bi-directional Ablation Catheters and Therapy™ Cool Path™ Irrigated Ablation System
Hemostasis Management Devices: Angio-Seal™ Evolution, RadiStop™ and FemoStop™ Gold
CRM Products: Current™ Plus ICD, Promote™ Plus CRT-D, QuickFlex™ LV Lead, OptiSense™ Optim™ Pacing Lead, Tendril™ STS Lead, and SJM Confirm™ Implantable Cardiac Monitor
Products for sale in the U.S. will be on display in booth 317 and products for sale in international markets will be in booth 311 at the World Trade Center Exhibit Hall on Thurs., Jan. 14 from 11a.m. - 5 p.m., Fri., Jan. 15 from 10 a.m. - 5 p.m. and Sat., Jan. 16 from 9:30 a.m. - 2 p.m. For additional information about the products displayed in the St. Jude Medical booth, please visit SJMprofessional.com.
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. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
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 Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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