News

Compiled by EPLabDigest

Compiled by EPLabDigest

HeartLight Endoscopic Ablation System Now Available in the UK

CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that the HeartLight EAS is now available in the United Kingdom. The first AF patients were treated at The Heart Hospital in London on Wednesday, August 17, with additional cases to take place throughout the month.

The procedures were performed by Drs. Edward Rowland and Oliver Segal, consultant cardiologists at The Heart Hospital, and proctored by Dr. Boris Schmidt of Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, an international expert on the HeartLight EAS technology. The Heart Hospital is part of the University College London Hospitals Foundation Trust and anticipates HeartLight EAS could be used in up to half of the nearly 400 AF ablation procedures performed at the hospital every year.

Stephen Sagon, President and CEO of CardioFocus, Inc. said, “With the addition of this important UK center, we are continuing the introduction of HeartLight EAS to leading medical hubs across Europe. We are encouraged by the quick adoption of this technology by leaders in the electrophysiology community and are pleased to bring the possibility of a more durable, reproducible ablation option to an expanding number of AF practitioners and their patients.”

HeartLight EAS is a unique catheter ablation technology that incorporates an illuminating endoscope to provide physicians with direct visualization within a beating heart, in real time and without radiation. It also features a compliant, dynamically adjustable balloon catheter for improved contact with the pulmonary vein (PV) ostium and utilizes laser energy for more efficient, precise ablation.

Recent data has demonstrated that approximately 86% of PVs remained persistently isolated after three months following a single procedure with HeartLight EAS,1 with 65% of patients achieving durable freedom from AF.2 The technology is available at sites across Europe including Germany, Italy and the Czech Republic and will soon be the subject of a pivotal clinical trial in the United States.

1 Dukkipati S. Persistent Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: Results of a Multicenter PV Remapping Study. Presented at Heart Rhythm 2011.
2 Reddy VY, et al. Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience. Presented at Heart Rhythm 2011.

First Patient Enrolls in St. Jude Medical Supported Landmark Study Investigating Atrial Fibrillation Treatment Options

St. Jude Medical, Inc., a global medical device company, announced that the first patient was enrolled in the EAST (Early comprehensive Atrial fibrillation Stroke prevention Trial) clinical trial. The investigator-initiated study seeks to determine whether an early, comprehensive, standardized intervention program can help prevent adverse cardiovascular outcomes associated with prolonged atrial fibrillation (AF), including stroke and death. More specifically, the EAST study will evaluate whether an early and comprehensive rhythm control treatment of patients with early-onset AF produces better patient outcomes than usual care alone.

The clinical sponsor of EAST is AFNET (German Competence Network on Atrial Fibrillation). The European Heart Rhythm Association (EHRA) is an equal scientific partner in the trial. The planned enrollment is more than 3,000 patients from 200 centers in Europe, with locations in Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, and the United Kingdom.

“St. Jude Medical believes it is important to marshal together the resources, people and technologies to help find a cure for AF,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “We can help accelerate the achievement of this goal by investing in clinical trials such as EAST, which address some of the most important questions about AF within the scientific community.”

In addition to EAST, St. Jude Medical also is a major supporter of the CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) pivotal trial.

Günter Breithardt, AFNET speaker, Angelo Auricchio, and Panos Vardas, current and past EHRA president, said in a joint statement, “Investigator-initiated clinical research with a relevant impact requires good ideas, perseverance, a network of colleagues, but also financial resources. As sponsor and co-organizer of the EAST trial, we therefore highly appreciate the financial support from St. Jude Medical and Sanofi to make this important clinical research possible.”

Trial Background

AF is a condition in which the upper chambers of the heart (atria) beat rapidly and erratically, affecting the heart’s ability to adequately pump blood to its lower chambers (ventricles) and subsequently to the rest of the body. Some of the complications caused by AF are increased risk of death or stroke, increased severity of stroke, increased hospitalizations, and reduced quality of life due to palpitations and other AF-related symptoms.

AF can have an impact on the heart as early as a few weeks after onset, causing cycles of remodeling, dysfunction and additional triggers which help progress the disease. These cycles both maintain and perpetuate AF from the state of initial detection, to paroxysmal (AF that begins suddenly and ends spontaneously) to persistent (recurring episodes lasting more than seven days) to permanent (ongoing and long term).

EAST is a prospective, parallel-group, randomized, open, blinded, endpoint assessment. The multicenter study seeks to understand whether improved rhythm control therapy could prevent death and stroke. Specifically, whether an earlier initiation of rhythm control therapy, when included in a comprehensive AF management strategy, has the potential to maintain the heart’s rhythm more effectively, prevent AF-related complications, and disrupt the cycles that maintain AF and cause complications.

Commenting on the need for the EAST study, Prof. Dr. Paulus Kirchhof, coordinating investigator of the trial, said, “The trial is based on the observation that insufficient, non-structured and delayed therapy of the multiple factors that maintain AF and cause its complications has most likely contributed to the limited effectiveness of rhythm control interventions in past trials. This trial takes an important step forward to learn more about the value of rhythm control therapy to improve the lives of AF patients by accounting for the cycles that initiate and maintain the disease and contribute to AF-related complications.”

Patients with recent-onset AF at risk for stroke or death are eligible for trial enrollment. Participants will be randomized to either an “early, comprehensive, standardized” intervention to maintain sinus rhythm in addition to usual care, or to usual care alone. Early intervention will include antiarrythmic drug therapy and/or pulmonary vein isolation (PVI) using catheter ablation as well as ECG monitoring of therapy. Usual care follows standardized therapy under the 2010 ESC guidelines for the treatment of AF.

The primary outcome of EAST is the composite of cardiovascular death, stroke and heart failure or acute coronary syndrome (hospitalization). There will be outpatient follow-up at 12, 24 and 36 months.

IntriCon Receives FDA 510(k) Marketing Clearance for Centauri Cardiac Diagnostic Monitor

IntriCon Corporation, a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for the Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring (CDM) device. The Centauri combines event recording with wireless transmission of patient data allowing physicians to continuously monitor patient cardiac events remotely.

Mark S. Gorder, president and chief executive officer at IntriCon, said, “With rising health care costs, we are excited to offer a device that will not only improve patient quality of life, but also reduce treatment costs by providing the ability to identify asymptomatic cardiac events remotely. The Centauri follows current industry trends of shifting patient care from expensive health-care settings to the home which not only reduces costs but improves patient comfort.”

The Centauri device provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. With continuous monitoring, automatic arrhythmia detection and wireless transmission of the recorded cardiac activity to a licensed physician for review, Centauri offers flexibility and comfort not found in traditional devices.

Given the timing of the FDA clearance, IntriCon expects to release the product in the third quarter of 2011 and anticipates modest revenue contributions in the 2011 fourth quarter.

Medtronic Receives FDA Approval for Advisa DR MRI SureScan® Pacing System Clinical Trial

Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Advisa DR MRI SureScan® pacing system. FDA approval of the Advisa MRI System Study protocol enables Medtronic to become the first company to conduct a randomized, controlled clinical trial of a second-generation pacing system designed for use in the MRI environment under specific scanning conditions in the US. The Advisa DR MRI SureScan pacing system is not approved by the FDA for US commercial distribution.

“This clinical trial is an important milestone toward providing another innovative pacing system option for patients who may need access to the potentially life-saving benefits of MRI technology during the lifetime of their device,” said Edward J. Schloss, MD, medical director of electrophysiology at The Christ Hospital in Cincinnati, Ohio.

Dr. Schloss implanted the first patient in the US with the investigational Advisa MRI System as part of the clinical trial through The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati.

The Advisa MRI study is a prospective, randomized controlled, non-blinded, multicenter worldwide investigational study to confirm safety and effectiveness of the pacing system in the clinical MRI environment when subjects receive MRI scans under specified conditions, as well as provide data on MRI image quality in the presence of pacing system. In the US, the Medtronic Advisa MRI System featuring the SureScan technology is comprised of the Advisa MRI IPG Model A2DR01 and the CapSureFix MRI active fixation Model 5086MRI lead.

Until FDA approval of Medtronic’s first-generation Revo MRI SureScan® pacing system in February 2011, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.1-4 MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scan, and critical for early detection, diagnosis and treatment. It is estimated that 50–75 percent of patients with an implantable cardiac device will need an MRI scan over the lifetime of their device.

“The FDA approval of the Advisa MRI System Study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the MRI environment,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.

About Advisa DR MRI SureScan®

Advisa MRI, Medtronic’s second-generation pacing system in a portfolio of pacing systems designed, tested, and approved for use as labeled with MRI machines has been available in Europe since 2010. Patients with Advisa MRI in approved countries have access to full body scans, without positioning limitations in the MRI scanner.

1 Faris OP, Shein M. Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. Circulation 2006;114:1232-1233.
2 Roguin A, Schwitter J, Vahlhaus C, et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346.
3 Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: Endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878-2891.
4 Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol 2005;28:326-328.

AmbiCom Signs Contract with Major Medical Device Manufacturer to Develop Wi-Fi Solution for Defibrillator Applications

AmbiCom Holdings, Inc., a leader in the development of wireless products for medical equipment suppliers, announced that it has signed an agreement with a major medical device manufacturer to jointly develop a Wi-Fi card application for its cardiac defibrillator product.

The agreement calls for AmbiCom to design and develop a dual-band 802.11a/b/g/n Wi-Fi card for integration with the manufacturer's cardiac defibrillator product. The manufacturer will pay a fee of $470,000 for AmbiCom to develop the software and hardware architecture of the Wi-Fi card solution, including development, standard testing, and technical consultations. AmbiCom has already received an upfront fee of $125,000 to begin development, and management expects all work to be completed by October 1, 2011. These fees do not include the follow-on revenue expected from the sales of the actual Wi-Fi cards to manufacturer, post-development.

“We are very excited about this opportunity to jointly develop this hardware and software application for this manufacturer for its primary defibrillator product,” said John Hwang, CEO and Chairman of AmbiCom. “This is another example of the relationships — this is a long-term medical device partner of ours — that we have built over the years on the strength of our technology solutions and underlying customer and technical support. By being directly involved in the development of these solutions from the start, we can ensure this and other device partners the long-term support they need to support their own end customers.”

Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in the United States to Use ThermoCool® SmartTouch Contact Force Sensing Catheter

On July 6, 2011, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center became the first facility in the United States to use the ThermoCool® SmartTouch Contact Force Sensing Catheter as part of a clinical trial. The procedure was performed by Andrea Natale, MD, FHRS, FACC, FESC, cardiac electrophysiologist and executive medical director of TCAI, to treat atrial fibrillation (AF).

The ThermoCool® SmartTouch Contact Force Sensing Catheter is an advanced, pressure-sensing ablation catheter. During cardiac ablation, the ThermoCool® SmartTouch Contact Force Sensing Catheter enables the measurement of catheter tip contact force and direction inside the heart. The force and contact information is graphically displayed on the Carto® 3 Mapping and Navigation System with the Carto® 3 SmartTouch Software Module, creating the only fully integrated solution in the electrophysiology market, which combines contact force with 3D mapping and navigation capabilities.

“One of the key issues with current ablation catheters is that they provide limited tactile feedback,” Dr. Natale said. “During catheter ablation, it is difficult for physicians to determine whether or not they are maintaining good contact with the tissue. Maintaining close contact with the tissue and knowing how much pressure you are applying result in the creation of better lesions, and ultimately means better outcomes for the patients.”

Not only could the ThermoCool® SmartTouch Contact Force Sensing Catheter increase the success rates of cardiac ablation procedures, it could also reduce the chance that a patient will need an additional follow-up ablation procedure, as well as increase safety for patients.

“In the hands of a less experienced physician, current ablation catheters can puncture the heart if too much pressure is used,” Dr. Natale said. “Since this new catheter allows physicians to measure the pressure, they are less likely to damage the patient’s heart.”

Dr. Natale also performed the first human case in the world, which took place in Europe in February 2010, along with professor Josef Kautzner, MD, PhD, FESC, head of the department of cardiology at the Institute for Clinical and Experimental Medicine, Cardiology, and Hiroshi Nakagawa, MD, PhD, of the Heart Rhythm Institute at the University of Oklahoma Health Sciences Center.

The ThermoCool® SmartTouch Contact Force Sensing Catheter is currently being studied by physicians and researchers at TCAI. It has not yet received approval by the U.S. Food and Drug Administration.