St. Jude Medical.
CLINICAL EVENTS CALENDAR
- Saturday, March 13, 2010 - 23:00ACC.10 and i2 Summit 2010http://www.acc.org
- Tuesday, May 4, 2010 - 23:00SCAI 33rd Annual Scientific Sessionshttp://www.scai.org
- Tuesday, May 11, 2010 - 23:00Heart Rhythm: 31st Annual Scientific Sessionshttp://www.hrsonline.org
- Monday, May 31, 2010 - 23:00CEPIA Introduction to Cardiac Electrophysiologyhttp://www.cepia.com.au
EP Lab Digest News Wire
Sanofi-aventis and Bristol-Myers Squibb Announce Important Updates to PLAVIX U.S. Prescribing Information
Sanofi-aventis U.S. and Bristol-Myers Squibb Company announced revisions to the U.S. prescribing information for PLAVIX® (clopidogrel bisulfate), which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX in patients who have a genetic variation leading to reduced formation of the active metabolite. These patients, who are designated as poor metabolizers, represent, according to the prescribing information, approximately 2% of whites, 4% of blacks, and 14% of Chinese. The percentage of poor metabolizers is estimated to be approximately 3% of the population, based on published studies.
Patients should continue taking PLAVIX unless told to do otherwise by their healthcare professional. They should talk with their healthcare professional if they have any concerns about PLAVIX.
The U.S. Food and Drug Administration (FDA) issued a press release on this update, which is included below:
FDA Announces New Boxed Warning on Plavix
St. Jude Medical to Showcase Robust Portfolio of Products for Cardiac Care at American College of Cardiology (ACC) 2010
St. Jude Medical, Inc. announced it will display products and technologies from the company’s wide array of clinical solutions in the cardiology, cardiac surgery, atrial fibrillation and cardiac rhythm management markets at ACC 2010.
“St. Jude Medical is pleased to showcase our latest cardiac care solutions, from technologies that help to better connect patients to physicians, to devices proven to improve patient outcomes,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “We offer a full range of products and technologies from across the company designed to decrease hospitalizations, improve patient quality of life and reduce healthcare costs.”
Sanford Heart Hospital Physician First to Perform Innovative Procedure in South Dakota
Sanford Heart Hospital cardiologist Scott Pham, MD, FACC performed the first laser lead extraction procedure in the state of South Dakota this week. In order to perform this procedure, Dr. Pham used a new state-of-the-art technology that uses a laser to remove one or more cardiac leads from inside the heart. A lead is a special wire or wires that deliver energy to the heart muscle. When leads are not working properly, it can cause the pacemaker/defibrillator to malfunction. The leads may need to be removed because of infection.
During the procedure, a circle of fibers that emit pulses of energy travels over the lead. A “cool” ultraviolet laser light is used to safely, effectively and efficiently dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed.
Study of NewCardio's CardioBip Demonstrates Performance for Remote Wireless Monitoring and Detection of AF
NewCardio, Inc., a cardiac diagnostic technology provider, announced that the Heart Rhythm Society (HRS) has accepted an abstract detailing the superior performance of NewCardio's patented CardioBip™ technology for remote wireless monitoring and detection of atrial fibrillation (AF). The study results, which discuss the use of CardioBip for improved AF monitoring and detection, are scheduled for oral presentation at the Heart Rhythm Society 31st Annual Scientific Sessions, May 12-15, 2010, in Denver, Colorado.
The abstract, titled "Three-dimensional Atrial Signal Reconstruction Facilitates Remote Detection Of Atrial Fibrillation," was written by Alexei Shvilkin, MD, PhD, Dejan Vukajlovic, MD, Vladan Vukcevic, MD, Ihor Gussak, MD, PhD, Bosko Bojovic, PhD, Uros Mitrovic, MS and Goran Simic, MS. The abstract highlights a new AF detection algorithm based on NewCardio's proprietary 3-D ECG processing platform.
Spectranetics' LExICon Study Achieves 97.7% Clinical Success Rate in Removal Procedures
Spectranetics Corporation announced publication of the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study in the February 9th issue of the Journal of American College of Cardiology. The study evaluated the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath (SLS® II).
Stereotaxis System Procedure Featured on NBC's The TODAY Show
Stereotaxis announced that NBC's The TODAY Show featured Dr. Mauricio Arruda, a leading electrophysiologist and Director of the University Hospitals Heart & Vascular Institute in Cleveland, Ohio, performing a live cardiac ablation procedure using a Stereotaxis system during its broadcast. The patient was a 69-year-old woman who suffered from a severe cardiac arrhythmia. The procedure was completed successfully.
The Stereotaxis system allows the physician to control the tip of the catheter by using magnetic fields, providing reduced radiation exposure, a low major adverse event rate and clinical results which mimic the best hands in the world.
The TODAY Show segment is available at http://bit.ly/cLSYg9. For more information on Stereotaxis, please visit www.stereotaxis.com.
About Stereotaxis
CareFusion Announces 5-Year, Sole Source Pyxis(R) Perioperative Solutions Agreement With CHRISTUS Health
CareFusion, a leading, global medical device company, announced that it has entered into a 5-year sole source agreement with Dallas-based CHRISTUS Health, one of the top ten Catholic health systems in the U.S., to upgrade their existing Pyxis® supply point-of-use inventory management systems while expanding further into the operating rooms and cath labs.
CareFusion's Pyxis® Perioperative Solutions provide a measurable return on investment and integrate with health care information systems to improve financial performance, streamline workflow, facilitate regulatory compliance and enhance data analysis.
Cardima’s PATHFINDER® Diagnostic Catheters Receive Marketing Approval in Japan
Cardima, Inc., a medical device company focused on the diagnosis and treatment of atrial fibrillation (AF), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to re-enter the Japanese market with its family of guidewire-based, multi-electrode PATHFINDER® diagnostic mapping catheters. Cardima’s PATHFINDER catheters, which are designed for accessing and mapping the vasculature of the heart wall to facilitate treatment of arrhythmias, will be imported into Japan through an exclusive distribution agreement with medical device distributor Robert Reid Inc., an import license holder, and marketed through Japan Lifeline Co. Ltd., an exclusive distributor of Robert Reid Inc.
Findings Suggest Cardiovascular Devices Often Approved By FDA Without High-Quality Studies
Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a study in the December 23/30 issue of JAMA. The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.
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