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Electrophysiology News
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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.
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.
New Medtronic Implantable Cardiac Monitor Gives Physicians Valuable Insights Into the Cause of Unexplained Fainting
Medtronic, Inc. announced the European introduction of the Reveal® DX, a new Insertable Cardiac Monitor that offers diagnostic and monitoring information related to syncope (fainting) in patients. The device recently received CE Mark, and the first implant of Reveal DX took place at Ospedali del Tigullio in Lavagna, Italy, by Prof. Michele Brignole, MD. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor records important data before, during and after a syncopal event.
Stereotaxis Announces 1,000 Worldwide Atrial Fibrillation Procedures with Niobe System
Stereotaxis, Inc. announced that it has achieved an important milestone of over 1,000 atrial fibrillation procedures performed worldwide with its proprietary Niobe magnetic navigation system. Atrial fibrillation is a complex arrhythmia, typically originating in the left atrium of the heart, affecting millions of patients worldwide.
Survival After In-Hospital Cardiac Arrest Dismal
Patients who suffer cardiac arrest while in the hospital and are successfully resuscitated may not live for very long, a study suggests. However, those who receive internal cardioverter-defibrillators (ICDs) have a significant advantage, it seems.
New Heart Guidelines Aim to Stop Newborn Defects
The American Heart Association released new recommendations to help women reduce the risk of giving birth to children with heart defects.
The four key recommendations include: talk to your doctor, take a daily dose of folic acid, avoid people with the flu and review all medication use with your doctor even if it is over-the-counter.
Boston Scientific Releases Remote Monitoring Data from First 10,000 Patients Using its Wireless LATITUDE® Patient Management System
Boston Scientific Corporation released data reflecting clinical event notification statistics from the first 10,000 patients* monitored on the LATITUDE® Patient Management System. This data represents the industry’s largest experience with wireless remote monitoring of implantable cardiac devices for one year.
St. Jude Medical Announces FDA Clearance and European Approvals for Cardiac Mapping and Navigation Software
St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark for the EnSite™ System Version 7 software, and European CE Mark of the EnSite Fusion™ Registration Module. The new products will help physicians create more detailed images of the heart for navigating during electrophysiology (EP) procedures that treat complex arrhythmias.
Ascent Healthcare Receives 510(k) Clearance to Reprocess Siemens ACUSON AcuNav™ Ultrasound Catheter Up to Four Times
Ascent Healthcare Solutions announced that the U.S. Food and Drug Administration (FDA) has increased the number of times that Ascent can reprocess the AcuNav™ Ultrasound Catheter from two to up to four times. Validation data submitted to the FDA covered all available models.
The catheters provide electrophysiologists and interventional cardiologists with high- quality images and blood flow information throughout the entire heart for the diagnosis of certain cardiac arrhythmias.
Hansen Medical Announces Joint Development and Co-Marketing Agreements with St. Jude Medical Targeting Electrophysiology Procedures
Collaboration Will Combine Robotic Catheter Navigation with Cardiac Mapping Technology to Enable Integrated EP Solution
No Genetic Link Found for Heart Risk, Study Says
Genetic testing failed to find any gene mutations that predict a higher risk of heart disease, a recently released study said. Scientists at Yale University worked up the genetic profiles of nearly 1,500 people to examine 85 genes that smaller, earlier studies suggested might confer susceptibility to heart problems.
Guidelines Help Coaches Prepare for Cardiac Arrest
Helping high school and college athletic programs prepare for and respond to sudden cardiac emergencies in student athletes is the goal of guidelines published this month in the journal Heart Rhythm.
Medtronic Commences Clinical Trial of Innovative Delivery Technology for Heart Failure Patients with Implanted Cardiac Resynchronization Devices
Medtronic Inc. announced the first clinical implants in the United States of the Medtronic Attain Ability™ over-the-wire lead (Model 4196), a dual-electrode left ventricular (LV) lead for use in heart failure patients with cardiac resynchronization therapy (CRT) devices.
ZOLL Receives Marketing Clearance for M Series with Real CPR Help Technology
ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, announced that it received clearance from the U.S. Food and Drug Administration (FDA) to market and sell the ZOLL M Series® with Real CPR Help™ technology.
St. Jude Medical Completes Milestone to Standardize Patient Medical Records
St. Jude Medical, Inc. announced it has successfully completed the testing process established by the IHE (Integrating the Healthcare Enterprise), an initiative promoting the adoption of standards that enable healthcare information to be shared seamlessly across clinical settings. The testing took place during IHE's annual Connectathon in Chicago.
CryoCor Provides PMA Update
CryoCor, Inc., a medical device company focused on the treatment of cardiac arrhythmias, announced that, based upon additional information from CryoCor, the U.S. Food and Drug Administration (FDA) may no longer need to convene an Advisory Panel meeting to render a decision on CryoCor's PMA for the treatment of atrial flutter. The additional information CryoCor is providing indicates a higher chronic effectiveness than in the amended PMA filing.
Ascent Healthcare Solutions Launches New Web site
Ascent Healthcare Solutions announced the launch of a redesigned, intuitive Web site, www.ascenths.com, containing extensive information about the company, which resulted from the 2006 merger between Alliance Medical Corp. and Vanguard Medical Concepts. The combination made Ascent the largest independent third-party reprocessor of single-use medical devices (SUDs) in the nation.
Philips Introduces New Imaging Tool to Help Physicians in Dealing with Treatment of Complex Cardiac Arrhythmias
Royal Philips Electronics announced the commercial release of Philips EP navigator, an easy-to-use, innovative imaging tool that will support clinicians in the treatment of complex cardiac rhythm disorders. EP Navigator combines pre–interventional 3-D CT images of a patients’ cardiac anatomy with live X-ray fluoroscopy catheter position information in a single image. This allows physicians to navigate more easily through the heart during complex procedures and enables them to work with greater confidence, in a more intuitive way.
ProRhythm Initiates U.S. Pivotal Trial for HIFU Ablation System:
focusAF Study Evaluates HIFU Treatment for Atrial Fibrillation
ProRhythm, Inc. announced the treatment of the first patient with the company's proprietary HIFU (High Intensity Focused Ultrasound) Ablation System in the "focusAF" clinical study for the treatment of atrial fibrillation (AF). This is a critical step in the FDA approval process and comes after the successful conclusion of the feasibility phase of the trial.
Medtronic Launches Public Awareness Campaign to Address one of the Nation’s Leading Causes of Death
Medtronic, Inc. announced the launch of a national campaign designed to raise awareness of sudden cardiac arrest (SCA), its risk factors, and the role of implantable cardioverter-defibrillator (ICD) therapy in saving lives. SCA is one of the nation's leading causes of death — claiming more lives than breast cancer, lung cancer, and HIV/AIDS combined.
Hansen Medical Announces Successful Completion of Clinical Trial for Sensei Robotic Catheter System
Hansen Medical, Inc., a developer of new generation robotic technology for accurate and stable control of catheter movement in 3D during cardiac procedures, announced the successful completion of a clinical trial and seven-day follow-up using the Sensei™ Robotic Catheter System.
The 20-patient prospective trial was an observational study using the Sensei system to guide catheters into the heart for mapping heart anatomy — a critical step in identifying heart tissue that generates abnormal heart rhythms, often requiring treatment. Data from the follow-up showed no device-related adverse events, and is being prepared as part of a submission to the U.S. Food & Drug Administration (FDA) in support of a 510(k) currently under review.
CryoCath Treats First Patients with New SurgiFrost XL
CryoCath Technologies Inc., announced that the first patients have been treated with SurgiFrost XL, a new minimally invasive surgical probe for treating cardiac arrhythmias which the U.S. Food and Drug Administration provided 510(k) clearance for in late 2006. It also received CE mark approval during this same time period.
“My experience with SurgiFrost XL in a pre-clinical setting confirms its ability to create durable, transmural lesions in a beating heart,” said Dr. Saqib Masroor from Hackensack University Medical Center in Hackensack, New Jersey. “Given these results, SurgiFrost XL presents physicians with a viable, minimally invasive option to treat cardiac arrhythmias in stand-alone procedures.”
Statement on Passage of the Tax Relief and Health Care Act of 2006 Attributed to Dwight W. Reynolds, MD, FHRS, President, Heart Rhythm Society
"We at the Heart Rhythm Society are very pleased that our leaders in the Senate and the House of Representatives have worked together to pass legislation that allows physicians to continue to deliver high quality care to our patients.
"Nevertheless, the Tax Relief and Health Care Act only provides a temporary fix to the proposed Medicare cuts to physician services by freezing this update at the current rates for 2007. Without accurate and appropriate reimbursement, physicians will not be able to dedicate resources to important quality improvement measures also outlined in this legislation, which ultimately lead to improved patient care.
Parent Heart Watch Helps Facilitate South Miami Heart Center Donation of Defibrillators (AEDs) to Miami-Dade Public Schools
Parent Heart Watch (PHW), a state-by-state network of parents dedicated to reducing the often-disastrous effects of sudden cardiac arrest (SCA) in children, announced their involvement in helping the South Miami Heart Center donate automated external defibrillators to the Miami-Dade County Public School System.
GE Healthcare Unveils Program to Support FDA/HL-7 ECG Standard: GE's ECG Program Allows Clinical Trial Sponsors to Directly Transfer Data to FDA ECG Warehouse without Expensive Certification Process
The U.S. Food and Drug Administration (FDA) is collecting ECG data in FDA HL-7 XML from clinical trials to assess cardiac safety, particularly the risk of a potentially fatal arrhythmia called Torsade de Pointes. GE’s new program allows Drug Application Sponsors and Contract Research Organizations (CROs) to transform data acquired on GE Healthcare ECG recording and analysis equipment to FDA XML format. The FDA XML format data can then be submitted directly to the FDA for review, thus eliminating the need to comply with the expensive process of certification common of existing solutions.
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