A Product, News and Clinical Update
for the Electrophysiology Professional
June 17, 2008

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Challenges from Atrial Fibrillation in Heart Failure

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How to Manage Heart Failure Patients with CRT Devices

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These activities are supported by an educational grant from Biotronik.

NEWEST PERSPECTIVESON DRUG-ELUTING STENTS

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Release Date: June 10, 2008
Expiration Date: June 10, 2009

This activity is supported by an educational grant from Abbott Vascular.
HOW TO DEVELOP AN AF ABLATION PROGRAM: Making AF Ablations Work Efficiently in the Real World

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Release: JUNE 17, 2008
Expires: JUNE 17, 2009
This activity is supported by an educational grant from St. Jude Medical.


ADVANCED TOOLS ALLOWING DYNAMIC REGISTRATION as a Guide for Complex Left Atrial Ablations

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Release Date: June 15, 2008
Expiration Date: June 15, 2009

This activity is supported by an educational grant from St. Jude Medical.


New Developments in 3D Imaging: Pushing the Boundaries of Today’s EP Lab

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Date: June 11, 2008
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COMPLIMENTARY LIVE Webcast

Infection Prevention for Minimally Invasive Interventions:

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Featured Articles by Joseph C. Marek, MD and Moeen Saleem, MD, Midwest Heart Foundation, Midwest Heart Specialists

Midwest Heart Foundation (MHF) was established in 1988 as a non-profit research and education foundation dedicated to improving the prevention and management of cardiovascular and related diseases through research, education and community leadership.
MHF augments the efforts of the American Heart Association, which brings national attention to heart disease by making things happen at the community level such as building relationships and delivering programs.

by Mauricio Lomba, Project Manager and Arts Lead, SE London Cardiac and Stroke Network (SELCSN)

The Silent at Heart Project uses art as an expressive means to promote awareness of sudden cardiac death in the United Kingdom. Read more about this innovative project.

Industry News

Endosense Achieves ISO 13485 Certification

Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has been awarded ISO 13485:2003 certification for its quality management system by the certification authority NSAI. The international standard for the medical device industry, ISO 13485:2003 verifies Endosense’s ability to provide medical devices and related services that consistently meet customer needs and regulatory requirements.

Endosense’s flagship product is the TactiCath™, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. With TactiCath, physicians can be assured that they are using just the right force for the right lesion creation.

NASA Selects LIFEPAK® 1000 Defibrillator from Physio-Control as First Automated External Defibrillator in Space:
LIFEPAK 1000 Defibrillator Deployed on International Space Station in July 2008


Physio-Control of Redmond, Washington, announced the LIFEPAK 1000 defibrillator has been deployed on the International Space Station (ISS) as the first automated external defibrillator (AED) in space. AEDs have become common in places such as airplanes, health clubs, and schools and now the LIFEPAK 1000 AED will be available for NASA crew members should someone experience sudden cardiac arrest in space.

The ISS has utilized manual defibrillators in the past, but NASA decided to now deploy an AED because it requires less training and maintenance, better enabling astronauts to respond to a medical emergency. The small size and light weight of the 1000 also helped minimize hardware mass and volume onboard the Space Station. NASA conducted extensive evaluations of 18 AEDs available worldwide before selecting the LIFEPAK 1000 defibrillator to protect the crew members of the ISS. The AED evaluations focused on user interface, ease of use, durability and detailed technical specifications related to the unique conditions encountered in space, including electromagnetic interference, pressure susceptibility, temperature, vibration, acceleration and other environmental factors. Additionally, Medical Operations personnel evaluated the use of LIFEPAK 1000 in zero gravity conditions aboard a NASA DC-9 test aircraft as part of developing their advanced life support use protocols.

Heart Rhythm Society Applauds Introduction of Sudden Cardiac Arrest Resolutions

he Heart Rhythm Society, co-chair of the Sudden Cardiac Arrest (SCA) Coalition, applauds the introduction of Senate Concurrent Resolution 93 and House Concurrent Resolution 393, which call for a National Sudden Cardiac Arrest (SCA) Awareness Month in October. Introduced by Representatives Lois Capps (D-CA) and Chip Pickering (R-MS) and Senators Mike Crapo (R-ID) and Byron Dorgan (D-ND), the resolutions will support efforts to raise awareness about the risk of SCA, improve the public’s ability to identify warning signs, encourage individuals to seek medical attention in a timely manner and promote the need for further research into the causes of this leading killer.

High Resolution Heart Images Now Available at Peak Stress

While treadmill exercise stress testing is an essential tool in the prevention, detection and treatment of cardiovascular disease, physicians are often challenged to gain clear images of the heart when a patient is at peak stress level.

That is changing at the Ohio State University Medical Center, where researchers have designed equipment to provide high resolution images of the heart at a critical stage of testing that have previously been difficult to obtain using standard testing procedures. Superior images of the heart are obtained with a test lasting less than one hour.

HUYA Bioscience International Announces Pre-IND Outcome for HBI-3000, a Promising Anti-Arrhythmia Compound Sourced From China

HUYA Bioscience International announced the outcome of its pre-investigational new drug (IND) consultation meeting with the U.S. Food and Drug Administration (FDA) for HBI-3000 (Sulcardine sulphate), a promising anti-arrhythmic compound sourced from China. The Agency reviewed and agreed with HUYA's IND-enabling CMC and toxicology plans and high-level Phase I plans pending review of non-clinical and clinical data to be submitted as part of the complete IND package. The FDA also agreed to accept data generated in China as 'supportive information' that will support the submission of a U.S. IND and the initiation of a U.S. Phase I trial. HUYA anticipates filing an IND application for HBI-3000 in Q1 2009.

Hansen Medical Announces FDA Clearance for CoHesion™ Module
New CoHesion Interface Merges 3D Visualization Guidance from St. Jude Medical with 3D Robotic Navigation


Hansen Medical, Inc., a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the CoHesion™ 3D Visualization Module for use in complex electrophysiology (EP) mapping procedures. This integrated EP solution offers a software interface between the Hansen Medical Sensei™ Robotic Catheter system and the EnSite™ System advanced mapping software from St. Jude Medical, Inc. Hansen Medical’s platform solution offers physicians the ability to instinctively navigate a catheter during the diagnostic phase of a complex cardiac arrhythmia procedure. The new CoHesion module imports the EnSite System’s 3D cardiac chamber model with anatomic labeling into the Sensei system’s main navigation window, allowing physicians to see the location of Hansen Medical’s Artisan™ Control Catheters within the heart in 3D.

FDA Approves Abbott’s Xience™ V Drug-Eluting Stent

The U.S. Food and Drug Administration (FDA) approved the Xience™ V everolimus-eluting coronary stent system for the treatment of coronary artery disease. Xience V is the only drug-eluting stent to have demonstrated superiority over Boston Scientific’s Taxus® paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. Xience V will be launched in the United States immediately. Abbott also supplies a private-label version of Xience V to Boston Scientific called the Promus™ everolimus-eluting coronary stent system. Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

Email Discussion Group

reply to | online submission form

Email Discussion Group: August 2008

Procedure Scheduling
I am looking for references pertaining to block scheduling of procedures in EP labs. Does anyone use this method and what are the rules?

— LeeAnne Hockey, RCIS, Sentara Heart Hospital, Norfolk, VA

(To reply to this question, please type “Procedure Scheduling” in your subject line.)

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Your questions and/or responses in our email discussion group may be published in a future issue of EP Lab Digest. Please note that this Email Discussion Group is for medical professionals only. EP Lab Digest's Email Discussion Group does not provide medical advice, diagnosis or treatment.

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Attention Readers:
Practical EP addendum

The editors of Practical Electrophysiology would like to point out a correction made in Table 27.1 on page 210. Please note that this table heading should read "Table 27.1: Isoproterenol Infusion Rate (µg/min) for Single-Stage HUT”. Please make a note of it in your records that it should read micrograms, not milligrams. We sincerely regret the error.

  • View the corrected table

  • Archived Article
    from the July 2008 issue

    Five Giants in Electrophysiology

    by Kevin O’Sullivan, Charlton Memorial Hospital, Fall River, Massachusetts

    I have been involved with cardiac catheterization and electrophysiology for almost 30 years. I started out as a biomedical technician and then gravitated into the cath lab. My first day in the lab was in January of 1979. Over the following decades, I moved from the clinical environment to industry and back again...several times.


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