CLINICAL EVENTS CALENDAR
- Saturday, November 8, 2008 - 15:00The American Heart Association Scientific Sessionshttp://www.scientificsessions.org
- Wednesday, November 19, 2008 - 00:00Brisbane, Australiahttp://www.aameda.org
- Friday, November 21, 2008 - 00:00EnSite 3D Mapping System Workshophttp://www.tcainstitute.com
- Thursday, November 27, 2008 - 15:001st Asia-Pacific Heart Rhythm Society Scientific Session (APHRS 2008)http://www.aphrs2008.com
EP Lab Digest News Wire
Ascent Recieves Only 510(k) Clearance for Reprocessed Biosense Webster Lasso® Variable Circular Mapping Catheters
Media Contacts:
Amendola Communications for Ascent Healthcare Solutions
480.664.8412
Jan Shulman, ext. 12, jshulman@ACmarketingPR.com
FOR IMMEDIATE RELEASE
EP cath labs can use savings to improve patient care while decreasing environmental toll
Phoenix, Ariz. – Nov. 13, 2008 – Ascent Healthcare Solutions, a leader in the medical device industry, promoting sustainable solutions to device procurement, announced today that it has received the industry’s first 510(k) clearance from the U.S. Food and Drug Administration (FDA) to reprocess the LASSO® 2515 Variable Circular Mapping Catheter manufactured by Biosense Webster. With this new clearance, Ascent continues to increase its portfolio of EP catheters to offer EP cath labs the ability to most effectively manage their resources while ensuring that clinicians have access to their preferred device to most effectively diagnose arrhythmias.
Good Samaritan Health System Among First to Implant Advanced Defibrillator
Good Samaritan Hospital (www.gshleb.org) was among the first in the nation to implant a TELIGEN™ implantable cardioverter defibrillator (ICD), which is used to treat sudden cardiac death.
GSH is among the first to bring this new technology to Central Pennsylvania. Dr. Jeffrey L. Williams, MD, MS, FACC, implanted the devices in two patients on August 7, 2008. This device represents an entirely new platform to treat sudden cardiac death and provides physicians enhanced clinical options for their patients. It is one of the smallest, thinnest implantable defibrillators in the world, featuring innovative new technologies with exceptional longevity.
Evidence Supports Utility of Remote Patient Management
and Fluid Monitoring Alerts to Potentially Reduce Heart Failure Hospitalizations
Medtronic OptiVol Alerts and CareLink Remote Patient Management Network May Give Physicians Early Warning to Intervene in Patients' Treatment
More than 22 million people worldwide suffer from heart failure,* and most heart failure hospitalizations are due to excessive fluid accumulation in the chest cavity. New data presented at the European Society of Cardiology (ESC) Congress shows that Medtronic, Inc. cardiac devices equipped with OptiVol® Fluid Status Monitoring Alerts™ may give physicians advance warning of their heart failure patients' worsening condition, thus reducing the rate of heart failure hospitalizations and clinically relevant events. Two-year follow-up data, presented by Dr. Maurizio Landolina of Italy, shows this may be as much as a 50 percent reduction. (OptiVol Alerts are currently investigational in the United States.)
Atritech Files Pre-Market Approval Application for Its WATCHMAN® LAA Closure Technology:
Enrolls First Patient in Continued Access Registry
Atritech, Inc. announced the filing of its Pre-Market Approval Application (PMA) to the Food and Drug Administration (FDA). The PMA contains the results of the PROTECT AF Clinical Trial, which began enrollment in early 2005. PROTECT AF evaluated the WATCHMAN® Left Atrial Appendage (LAA) Closure Technology versus the current standard of care, warfarin, in patients with non-valvular atrial fibrillation at risk of stroke. The trial enrolled 800 patients and was conducted in 60 centers across the United States and Europe.
New Data Shows Ranolazine Shortened QT Interval and Improved Cardiac Relaxation in Study of Patients with Long QT Syndrome:
Clinical Evidence for Unique Ranexa® Mechanism of Action
CV Therapeutics, Inc. announced that the Journal of Cardiovascular Electrophysiology has published a study of ranolazine showing that ranolazine significantly (p&0.001) shortened the QT interval of patients with a hereditary form of long QT syndrome called LQT3. Ranolazine also shortened cardiac relaxation time in the study.
In the study, five patients with LQT3 syndrome were prospectively investigated during an eight-hour intravenous infusion of therapeutic concentrations of ranolazine, with ECG and Echo evaluation before, during and after ranolazine administration.
Boston Scientific Announces First European Implants of New Devices to Treat Heart Failure and Sudden Cardiac Death
Boston Scientific Corporation announced the first European implants of its COGNIS™ cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN™ implantable cardioverter defibrillator (ICD). Physicians began performing implants in late February. Forty implants have been performed in 14 hospitals in six countries.
ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line
ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products, announced initial clinical results of stand-alone ablation procedures and an overall expansion into the stand-alone market, using the ATS CryoMaze™ product line. This line of surgical products, indicated for the treatment of cardiac arrhythmias, is designed to replicate the original cut-and-sew Maze procedure (also known as Cox-Maze-III) by freezing lines in the heart to re-direct electrical impulses. The Maze procedure is a widely known surgical technique developed by Dr. James L. Cox in the 1980s to treat atrial fibrillation (AF) with a high rate of long-term success.
Medtronic Announces Approval of the Sprint Quattro Defibrillation Lead in Japan
Medtronic, Inc. announced it received Japanese regulatory approval of the Sprint Quattro™ (Model 6944 and 6947) steroid-eluting right ventricular lead used with implantable cardioverter-defibrillators (ICDs) that detect and treat rapid and potentially lethal heart rhythms. The Sprint Quattro 6947, with bipolar sensing and dual coil defibrillation, is Japan’s first 8.6 French defibrillation lead to feature screw-in fixation. Screw-in fixation offers flexibility in securing the ICD lead in various right ventricle locations. The company hopes to receive reimbursement for Sprint Quattro by January 1, 2008, which then would allow for its immediate commercial launch in Japan.
Sorin Group Cardiac Rhythm Management Announces the First U.S. Enrollment in the OPTION Study
TELA Medical, Inc., a Sorin Group company, announced the first U.S. enrollment in the OPTION (Optimal Anti-tachycardia Therapy in ICD Patients without Pacing Indications) study by Dan Dan, MD, electrophysiologist and co-director of Cardiovascular Research of the Fuqua Heart Center at Piedmont Hospital, Atlanta, Georgia.
OPTION is a global, multi-center, prospective, single blinded, two-arm randomized trial. It evaluates ICDs with dual-chamber pacing and arrhythmia detection with therapy enabled for slow ventricular tachyarrhythmias in comparison to ICDs with single-chamber pacing and tachyarrhythmia detection with therapy disabled for slow ventricular tachyarrhythmias.
Survey Shows Physicians Need More Comprehensive Guidelines
According to survey results released, when 2007 Cardiometabolic Health Congress participants were asked what guidelines they follow for treating patients with multiple cardiovascular and metabolic risk factors, the largest group of respondents indicated that they didn't follow any particular set of guidelines and that better guidelines were needed.
The survey queried more than 750 cardiology, endocrinology, nephrology, and primary care clinicians who attended the 2007 Cardiometabolic Health Congress. The results are available at www.cardiometabolichealth.org/press.
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CME Showcase
Diagnosing Coronary Artery Disease: Advanced Cardiovascular Imaging Solutions Complimentary accredited web archive This activity is intended for physicians, nurses, and technologists. Symposium for Advances on Treatment Options for the AF Patient A-fib Ablation: |
 New Standards of Care for CRMD Antibiotic Protection Complimentary CME Accredited Webcast Dates: November 18, 2008 Time: 6:00 pm ET November 19, 2008 Time: 3:00 pm ET This activity is sponsored by the North American Center for Continuing Medical Education. |
 LUMEN 2009 - THE SYMPOSIUM ON OPTIMAL TREATMENTS FOR ACUTE MI Live Symposium Date: February 26-28 Location: Loews Miami Beach Hotel Miami Beach, Florida 33139 |
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