A Product, News and Clinical Update
for the Electrophysiology Professional
July 19, 2008

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September 2003 Press Releases
Industry News and Products:
September 2003 Press Releases
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ELA Medical Announces US Market Launch of Next Generation Implantable Defibrillators

Cardima Reports on First Commercial Uses of REVELATION Helix STX 2.5

Medtronic InSync II Marquis Heart Failure ICD System Receives U.S. FDA Approval

St. Jude Medical Announces FDA Approval of Active-Fixation Lead

Boston Scientific Announces FDA Approval of the EPT-1000 XP™

EP MedSystems Receives FDA Clearance for EP-WorkMate

ELA Medical Announces US Market Launch of Next Generation Implantable Defibrillators
System features smaller size and streamlined follow-up management features

ELA Medical has announced the US market launch of the ALTO® 2 line of implantable cardioverter defibrillators (ICDs). This ICD family offers reduced size and streamlined follow-up management features.

Alto 2
ALTO 2 has a new smaller size improving patient comfort and ease of implant without compromising energy. ALTO 2 has double the memory storage of previous devices. It is only 12 mm thin, making it one of the thinnest ICDs in the industry, and has a maximum energy of 31 joules. Dual-chamber (DR) and single chamber (VR) models feature advanced tachyarrhythmia diagnostics and tiered therapy to treat ventricular tachycardia and ventricular fibrillation which may cause sudden cardiac death.

The single chamber model, ALTO 2 VR, features an advanced discrimination feature using stability, acceleration and long cycle search.

ALTO 2 has streamlined patient follow-up with enhanced ELAVIEW® software functions. A “one-shot interrogation” enhancement provides physicians with a full view of each follow-up. Patient follow-up can be customized in response to specific clinic settings. Follow-up reports are automatically saved to a patient directory stored in the programming system. Direct access to Holter episodes, annotated markers, EGM tracings and rhythm statistics is available for quick and easy review.

Cardima Reports on First Commercial Uses of REVELATION Helix STX 2.5; Product Treats Atrial Fibrillation Originating in the Pulmonary Veins
Cardima®, Inc. is reporting the first commercial clinical use with the company’s REVELATION® Helix STX 2.5 or “large loop” version of the Revelation Helix for the treatment of atrial fibrillation (AF) originating in the pulmonary veins.

Under the supervision of Dr. Harold Tillman, Chairman of Justus-Liebig-Universitat in Germany, Dr. Ali Erdogan performed the first procedure on an AF patient using Cardima's REVELATION® Helix STX 2.5 catheter on August 6, 2003. Commenting on the relative ease and success of the procedure, Dr. Erdogan said, “After only one ablation round, there was an approximately 60–70% reduction of signals. I am impressed with the optimal signal reduction and the remarkable signal span during the ablation.” Dr. Erdogan expressed a noted clinical difference with this new configuration.

Dr. Jaswinder Gill, a consultant Cardiologist and Director of Electrophysiology at St. Thomas Hospital in London performed the second commercial procedure that had been reported to Cardima management on August 8, 2003. Dr. Gill informed management that this particular patient was an especially difficult case of AF to treat due to the position of the LUPV as compared to the RUPV. He reported that he made three circumferential rounds with the device and one selective round in the LUPV. Dr. Gill also noted a clinically relevant difference in the effect of the treatment. Dr. Gill already has another patient case scheduled for this treatment.
“We are very pleased with the outcomes of these first commercial cases with the new Helix and are encouraged that the results are concurrent with our clinical data,” said Gabriel Vegh, Chief Executive Officer of Cardima. “Milestones such as these are important as we continue our mission to work with the medical community to find a cure for AF.”

The REVELATION® Helix STX 2.5 used in both of these procedures provides a larger loop diameter to enable more effective ablation within larger diameter pulmonary veins or ablation at the pulmonary vein-left atrium junctions. Additional new features offered by the microcatheter that distinguish it from the current line of Cardima products includes sixteen (16) short (3 mm in length), fine wire electrodes that allow for greater radial hoop pressure, better tissue contact and an enhanced current density effect.

The REVELATION® Helix STX 2.5, is Cardima's fifth product in the REVELATION® series to receive European marketing approval, further expanding the capabilities of the electrophysiologist to treat AF on the left side of the heart by providing treatment options for larger pulmonary veins.

The REVELATION® Helix received CE mark in Europe in December 2001. The REVELATION® Helix, REVELATION® Helix ST, REVELATION® Tx, and REVELATION T-Flex are currently available in Europe and Canada. The REVELATION® Helix STX is available in Europe. The REVELATION® family of linear ablation catheters are not yet commercially available in the U.S.

Cardima, Inc. developed its patented, unique series of REVELATION® microcatheter systems for the mapping and treatment of AF, which the company believes is a significant market that is poorly served by current treatment alternatives. The REVELATION® series of microcatheters are minimally invasive, single-use microcatheters for the treatment of AF.

Medtronic InSync II Marquis Heart Failure ICD System Receives U.S. Food and Drug Administration Approval
System offers improved patient-tailored CRT options to help physicians manage HF patients.

Medtronic, Inc. announced United States Food and Drug Administration approval of the InSync II Marquis™ cardiac resynchronization therapy/ICD system, the company's third CRT system approved by the FDA in the past six months. The system, which offers improved, patient-tailored CRT options and effective ICD protection while minimizing shocks, will be available nationwide in a few weeks.

Heart failure is a chronic, progressive condition that has reached epidemic proportions, robbing patients of their energy, mobility and independence. The condition occurs when the heart has become damaged and gradually loses its ability to pump enough blood to meet the body's needs. Pioneered by the original Medtronic InSync® system, cardiac resynchronization therapy helps re-coordinate the beating of the heart, often with dramatic quality of life improvements for many heart failure patients.

"Heart failure patients often have complex conditions that require the most precise therapy available, and the InSync II Marquis system gives physicians the flexibility they need to tailor therapy according to distinct patient needs," said Steve Mahle, President, Medtronic Cardiac Rhythm Management. "By combining the best features of our cardiac resynchronization technology and the proven effectiveness of our industry-leading ICDs, we've created an extremely strong marriage of two important therapies."

The InSync II Marquis system offers unique anti-tachycardia pacing (ATP) options for pain-free termination of life-threatening tachyarrhythmias. This clinically proven capability can painlessly terminate up to 75 percent of fast ventricular tachycardia episodes instead of delivering unnecessary shocks. It also has the shortest battery charge-times available over the life of the device for maximum patient safety, and new left-lead monitoring tied to Patient Alert™, an exclusive Medtronic feature that warns patients with a series of tones when follow-up care is needed.

In addition, the system has new features that improve CRT delivery under a wider range of conditions, including atrial fibrillation, a common co-morbidity among heart failure patients. InSync II Marquis offers independent, programmable ventricular outputs, and unique heart failure management reports, both designed to help physicians better manage the subtle variations of each patient's condition.

About the size of a small stopwatch, the InSync II Marquis system also includes the advanced therapies of today's most implanted defibrillator, the Marquis DR® ICD, which rapidly detects and terminates fast ventricular heart rates. Sudden cardiac arrest kills approximately 450,000 people in the United States each year, and ICDs have been proven to be 99 percent effective in treating these potentially lethal rhythms.

St. Jude Medical Announces FDA Approval, CE Marking and First Implants of Active-Fixation Lead with Improved Visibility and Performance

St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) approval, European CE Marking, and the first implants of the Tendril® SDX Model 1688 active-fixation pacing lead. The Model 1688 lead, built upon St. Jude Medical's Tendril SDX cardiac lead technology, features a redesigned titanium distal tip with platinum markers and a radiopaque suture sleeve to facilitate precise location under fluoroscopy.

“The platinum markers significantly enhance fluoroscopic visibility, making it easier to verify helix extension and to achieve optimal placement,” said Dr. Charles Love, who performed the first U.S. implant of the Tendril SDX Model 1688 lead at the Ohio State University Medical Center in Columbus, Ohio. “The lead combines the best characteristics of the 1388 and 1488 to make a superb pacing lead. In addition, the ability to map intracardiac signals is excellent."

Dr. Johan Brandt performed the first European implant at University Hospital in Lund, Sweden, one of the most experienced implanting centers in Europe. “The implant procedure went very smoothly and I attribute that, in large part, to the Tendril SDX lead's clear visibility under fluoroscopy,” said Dr. Brandt. “The slim lead body and the surface coating results in excellent handling characteristics, which facilitated dual-lead introduction through the cephalic vein.” Both patients are doing well and the lead systems are performing as expected.

The Tendril SDX Model 1688 lead introduces refinements on the company's most popular pacing lead and responds to growing enthusiasm within the medical community for active-fixation devices.

“As the diagnostic and therapeutic functionality of cardiac rhythm management devices continues to expand, especially in the area of co-morbidity management, implanting physicians are looking for increased functionality and ease of use from their lead products,” said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. “St. Jude Medical is committed to continually advancing the state-of-the-art of lead technology across all of our lead product families. The feature enhancements embodied in the Tendril SDX Model 1688 are clear evidence of that commitment within the active-fixation pacing lead product segment.”

Based on physician feedback, St. Jude Medical has incorporated several significant improvements in the new lead. The Tendril SDX Model 1688 lead's 10 mm tip-to-ring spacing is designed to reduce far field sensing compared to leads with wider spacing. The new suture sleeve, impregnated with barium sulfate to facilitate radiopacity, features three symmetrical grooves to give implanting physicians more choices when anchoring the lead. The bipolar Tendril pacing lead has a small body, allowing it to be threaded through a thin 7 French sheath. Availability in a wider array of lengths (34–85 cm) gives physicians many treatment options.

The steroid-eluting lead reduces the energy requirement needed for pacing. The titanium nitride (TiN) fractal coating on both the tip and ring keep polarization low and St. Jude Medical's exclusive AutoCapture™ Pacing System compatibility high. (AutoCapture) is a threshold-tracking algorithm to combine capture confirmation with a unique backup safety pulse to ensure capture Beat-by-Beat™.

Pacemaker leads are typically inserted through a vein and connect the heart to a pacemaker. The Tendril SDX Model 1688 lead's active-fixation mechanism, containing a tiny helix that literally screws into the heart, allows a physician to securely position the lead in areas where a passive-fixation lead would not be stable.

Boston Scientific Announces FDA Approval of the EPT-1000 XP™ Cardiac Ablation System for the Treatment of Atrial Flutter
First and only 10 mm cardiac ablation catheter and 100-watt radiofrequency generator approved in the U.S.

Boston Scientific Corporation announcedthat it has received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its EPT-1000 XP™ Cardiac Ablation System for the treatment of atrial flutter.

It has been estimated that there are more than 200,000 new patients diagnosed with atrial flutter each year in the United States. The abnormal electrical signal causing atrial flutter occurs in the right atrium, in a circular pattern. Successful ablation procedures occur when a linear lesion is created across the tricuspid isthmus. This lesion interrupts the abnormal electrical circuit in a bi-directional manner, allowing the heart to return to normal rhythm permanently. The EPT-1000 XP Cardiac Ablation System allows for 8 mm and 10 mm tip electrodes to be used with up to 100-watts of radiofrequency energy to treat atrial flutter.

“The EPT-1000 XP Cardiac Ablation system provides increased benefit in the treatment of patients with atrial flutter,” said Gregory Feld, MD, Professor of Medicine, Director of the Electrophysiology Program at the University of California San Diego Medical Center and Principal Investigator of the clinical trial. “Our experience in treating atrial flutter shows an advantage to using a 10 mm tip electrode, such as the BLAZER II XP™ catheter, and a power generator with up to 100 watts of radiofrequency energy. The results of this multi-center study show shorter procedure times with fewer ablations and a chronic success rate for atrial flutter in excess of 96 percent. At present, Boston Scientific is the only company that has developed an ablation catheter with a 10 mm tip electrode and a 100 watt radiofrequency generator.”

“We are very excited to have received approval for the first 100-watt radiofrequency system used in the treatment of atrial flutter,” said Tom Coen, President of Boston Scientific's Electrophysiology business. “Evolutionary in design, the EPT-1000 XP system has demonstrated excellent results when compared with 50-watt and 70-watt systems on the market. We anticipate that the familiar user interface of the generator and predictable performance of the catheter will facilitate rapid market adoption.”

Dr. Robert Mittleman, Associate Medical Director at Boston Scientific, noted that “From our clinical trial study results, patients with atrial flutter who had an ablation with the EPT-1000XP Cardiac Ablation System demonstrated a dramatic improvement in their quality of life one month after the procedure, and this improvement persisted through the six-month measurement period. They also displayed a marked reduction in both arrhythmia-related symptoms and the use of medications to treat this condition.”

EP MedSystems Receives FDA Clearance for EP-WorkMate with RPM Catheter Navigation Technology
Company to Receive $1 Million Milestone Payment From Boston Scientific Corporation

EP MedSystems, Inc. announced that it received 510k market clearance notification from the U.S. Food and Drug Administration for its integration of Boston Scientific Corporation's RPM™ Realtime Position Management™ technology with EP MedSystems' EP-WorkMate® workstation. The new EP-WorkMate® with RPM™ will be the only EP recording system on the market to integrate advanced recording and stimulation, with anatomic modeling, advanced mapping and 3D navigation features, allowing electrophysiologic studies to be more efficient and user friendly.

EPMD also announced that the FDA 510k approval for the EP-WorkMate® with RPM™ meets a milestone term set forth in the company's joint-development agreement with Boston Scientific Corporation. Pursuant to the joint-development agreement, Boston Scientific agreed to purchase $1 million of EPMD unregistered common stock at market price upon notification of the 510k market clearance. The EP-WorkMate® with RPM™ integrated EP recording and navigation system is the culmination of a strategic joint-development project with the electrophysiology business unit of Boston Scientific Corporation.

Reinhard Schmidt, President and CEO of EP MedSystems commented, “This is a very exciting opportunity for EP MedSystems to enhance the present capabilities of the EP-WorkMate® pace and record system for both new users and our existing installed base. We showed leadership previously, in this market, when we integrated the EP-3 stimulator into the WorkMate platform, and have again demonstrated our dedication to advancing EP technology with the integration of anatomic modeling, advanced mapping and 3-D catheter navigation functions to the WorkMate platform. This clearly demonstrates that the EP-WorkMate® is the system of choice for all electrophysiology procedures. This 510k clearance will allow us to sell the EP-WorkMate® with RPM™ into the U.S. market, which we believe represents a sizable revenue opportunity for the Company in the future.”

Tom Coen, President of Boston Scientific's Electrophysiology division said, “We are pleased to collaborate with EP MedSystems through the integration of our RPM™ advanced mapping and 3-D catheter navigation technology into the EP-WorkMate® recording system. We believe that the resulting product will be of tremendous interest to our customers, who have clearly expressed a desire for a fully integrated, easy-to-use EP system that will meet all their conventional and advanced clinical needs. We look forward to working closely with EP MedSystems to facilitate bringing this new technology and added clinical capability of the combined system to the market and thereby, expand the number of electrophysiologists who can appreciate the benefits of RPM software and RPM-based catheters.”

EP Lab Digest - ISSN: 1535-2226 - Volume 3 - Issue 7: September - September 2003 - Pages: 40 - 44
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