News

Biosense Webster Announces FDA Approval of the ThermoCool® SF Catheter in the United States

Biosense Webster, Inc. announced the FDA approval of the new ThermoCool® SF irrigated ablation catheter in the United States.

The ThermoCool® SF NAV Catheter combines Biosense Webster’s latest irrigated ablation technology with the accurate visualization of the Carto®3 3D Mapping & Ablation System. The catheter was launched in Europe in October 2010, and has received excellent feedback from electrophysiologists who have used the product.

The ThermoCool® SF NAV Catheter is approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with Carto® Systems and Type 1 Atrial Flutter for patients 18 years and older.

Unlike competitive irrigated technologies, the innovative catheter design and breakthrough porous tip technology with Surround Flow technology of the ThermoCool® SF Catheter allows for uniform cooling of the entire catheter tip, and efficient heat dissipation when ablating. This cutting-edge innovation provides more effective cooling and allows half the volume load to the patient, when compared to the traditional ThermoCool® Catheter.

“We are proud to offer electrophysiologists in the United States our latest irrigated ablation technology to help treat patients with cardiac arrhythmias,” said Shlomi Nachman, Worldwide President, Biosense Webster.

About AF and Cardiac Ablation

Atrial fibrillation is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life.

Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. During cardiac ablation, energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy “disconnects” the pathway of the abnormal rhythm. Cardiac ablation is commonly used for “simple” arrhythmias, like Wolff-Parkinson-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. ThermoCool® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with Carto® Systems (excluding the NaviStar® RMT ThermoCool® Catheter).

Cameron Health Submits PMA Application to FDA for the S-ICD® System

Cameron Health, Inc. announced that it has submitted the Premarket Approval (PMA) application to the Food and Drug Administration (FDA) for the S-ICD System, the world’s only completely subcutaneous implantable defibrillator.

“This is an important milestone for our company. We look forward to working closely with the FDA through the review process to make this important technology available to more patients at risk of sudden cardiac arrest,” said Kevin Hykes, Cameron Health’s President and CEO.

The PMA submission included data from a 330-patient Pivotal IDE Clinical Study which evaluated the safety and efficacy of the S-ICD System in patients at risk of SCA.

“The S-ICD System avoids placement of leads or electrodes inside the heart. This has the potential to eliminate many of the serious complications related to traditional transvenous leads and represents an important alternative for many patients,” said Dr. Martin Burke, Professor of Medicine and clinical investigator from the University of Chicago.

In 2011, the FDA granted expedited review status for the S-ICD System PMA application.

About the S-ICD System

The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, removing the need for lead placement inside the heart. Essentially, the S-ICD System eliminates the major risks associated with transvenous leads. The S-ICD System detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias that can lead to sudden cardiac arrest. When abnormal arrhythmias are detected, the S-ICD System delivers an 80 Joule shock to restore the heart’s normal rhythm. Left unaddressed, these disorganized heart rhythms are often fatal.

Endosense Launches TactiCath® 75 Force-Sensing Catheter, Announces New Results of EFFICAS I Clinical Study

Endosense has announced the European launch of the TactiCath 75 force-sensing ablation catheter as well as results of the EFFICAS clinical study of contact force-sensing in catheter ablation procedures.

The TactiCath 75 is an 8.5 F sheath compatible, state-of-the-art open irrigated, steerable radiofrequency ablation catheter that employs the same proprietary force-sensing technology as the original TactiCath but features a longer, 75 millimeter curved tip. With the availability of both curve diameters, electrophysiologists can now address the vast majority of patient anatomies in the catheter ablation treatment of atrial fibrillation (AF). The TactiCath 75 is now offered commercially in Europe through Endosense’s distribution partner BIOTRONIK and is expected to be available soon for use in the TOCCASTAR U.S. investigational device exemption (IDE) study of the TactiCath.

In addition, Endosense has unveiled new results from its EFFICAS I European post-market study. The first in a series, EFFICAS I is a 46-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI), gap formation at three months, and atrial fibrillation (AF) treatment efficacy. While investigators performed the procedure with the TactiCath, they were blinded to contact force measurements; however, the contact forces applied were recorded. Patients were re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures were then analyzed to determine the relationship with lesion formation.

The new EFFICAS results have shown that the creation of a continuous line of ablation points performed with a minimum force of 10 grams and a minimum Force-Time Integral (FTI) of 400 gram seconds provides significantly higher success rates in electrical isolation per pulmonary vein segment.1 These minimum force and FTI parameters are the guidelines that were followed in the EFFICAS II clinical study, in which investigators took full advantage of the real-time, objective TactiCath contact-force control features to improve their ablation technique during lesion creation.

“The new findings from EFFICAS continue to demonstrate the clear value of contact-force sensing in catheter ablation procedures, as they prove that electrical reconnections caused by inadequate, non-transmural lesions can be avoided with the use force and FTI information,” said Jan Keltjens, Endosense president and chief executive officer. “Equally exciting are the suggested contact-force parameters for optimal lesion formation, which we have evaluated in EFFICAS II. These and other studies are key elements in our commitment to evidence-based medicine and establishing force sensing as part of the future standard of care.”

The EFFICAS II study was completed in October 2011, and Endosense expects to announce its results in the first half of 2012.

About Endosense

Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of contact-force measurement in catheter ablation with the development of the TactiCath, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Launched in April 2010 with a full release in September 2010, the second generation of the novel device has been used across Europe to treat more than 1,500 patient cases of AF and supraventricular tachycardia (SVT). Endosense is currently conducting several post-market clinical studies aimed at proving the superiority of the TactiCath force-sensing catheter over standard irrigated catheters, as well as the TOCCASTAR investigational device exemption (IDE) clinical trial.

Endosense is backed by Edmond de Rothschild Investment Partners, Neomed, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners and Initiative Capital Romandie.

  1. Neuzil, P, et al. “EFFICAS I Results – Are Low Contact Force Parameters Predictors for Gap Formation after Pulmonary Vein Isolation by Radiofrequency Catheter Ablation?” AHA abstract No. 18101, AHA 2011, Orlando, USA.

Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

Stereotaxis Announces Positive Results from First 50 Clinical Procedures Performed with New Niobe ES System

Stereotaxis, Inc. announced the completion of the first 50 clinical procedures using the company’s new Niobe ES system to treat patients with a variety of complex cardiac arrhythmias. A majority of the first 50 cases were performed to treat atrial fibrillation (AF).1 Positive initial results with the Niobe ES system in Europe demonstrate that the average time for completion of mapping and ablation for the initial AF patients was 69 minutes. The data was featured at the Boston Atrial Fibrillation Symposium 2012, held on January 12-14, 2012.

The Epoch platform, which encompasses the Niobe ES system, is the company’s new generation comprehensive solution for the electrophysiology (EP) laboratory. It is designed to improve efficiency with a fully-remote, networked and modular robotic, magnetic system that enables greater surgical precision and improved catheter control while reducing the risk of complications. Stereotaxis began initial shipments of the Epoch platform in mid-December 2011, including six system upgrades from the Niobe® II navigation system at leading medical centers in the United States and Europe.

Professor Carlo Pappone of Villa Maria Cecilia Hospital, Cotignola Italy, said, “My vision was to click on the map and for the catheter to quickly and precisely move to that spot. Today with the Epoch platform, this is a reality. I believe the Epoch platform is one of the most important innovations for the EP practice to date. With the Epoch technology all physicians can successfully and consistently perform high-quality AF procedures with the assurance of superior patient care.”

THE HEART HOSPITAL Baylor Plano in Plano, Texas was the first North American site to install the new Epoch platform, and the first hospital in the world to perform an EP procedure using the new system.

“Interventional physicians want to leverage advanced technology that minimizes surgical risks to the patient while increasing the likelihood of a favorable outcome,” said Brian DeVille, MD, FACC, electrophysiologist on the medical staff at THE HEART HOSPITAL Baylor Plano. “The new Niobe ES system will enable electrophysiologists on the medical staff to deliver therapy in a precise manner, while reducing X-ray exposure and procedure time for our patients.”

“The initial feedback and interest in our new Epoch platform has been very favorable,” said Michael P. Kaminski, President and CEO of Stereotaxis. “We look forward to continuing to build on the momentum of this milestone and have commitments for 12 additional system upgrades to Niobe ES which will be installed over the next few months.”

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation and reduced x-ray exposure.

Stereotaxis’ Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. The Odyssey Cinema Studio then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Odyssey solution then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to attract patients and promote collaboration.

The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere.

  1. Niobe ES is cleared for the U.S., but is not approved for treatment for atrial fibrillation.

Data from St. Jude Medical’s ASSERT Implantable Device Monitoring Study Published

St. Jude Medical announced the publication of results from the ASSERT cohort study in the New England Journal of Medicine (NEJM). The ASSERT study, or ASymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial, was designed to determine whether the detection of arrhythmias using pacemaker-based diagnostics predicts an increased risk of stroke in elderly, hypertensive patients without any history of atrial fibrillation (AF).

The study results, previously presented at an American Heart Association Scientific Sessions meeting, found that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias. The trial was sponsored by St. Jude Medical and was conducted by the Population Health Research Institute of McMaster University and Hamilton Health Sciences in Hamilton, Canada.

“Approximately 85 percent of atrial arrhythmias documented in the study were picked up only by the pacemaker, proving the device plays a very significant role in identifying patients with a higher risk of stroke,” said Dr. Jeff S. Healey, principal investigator for the arrhythmias program at the Population Health Research Institute. “This monitoring technology is a built-in diagnostic tool and a huge value-add to further assist physicians in properly treating their patients.”

The study included 2,580 pacemaker and ICD patients over the age of 65 with hypertension and no history of AF. Subclinical (non-symptomatic) atrial tachyarrhythmias detected by implanted devices occurred in over 10 percent of patients at three months. The risk of systemic embolism (or stroke) associated with non-symptomatic atrial tachyarrhythmias was 13 percent. The diagnostic data and alerts available through St. Jude Medical implantable devices allow physicians and patients to be notified whenever a patient experiences significant atrial arrhythmias in the heart’s upper chambers, such as AT or AF.

“The publication of these findings reminds us how important it is to identify patients with an increased risk of stroke. Diagnostic tools and remote monitoring capabilities already found in St. Jude Medical pacemakers and ICDs make it easier for physicians to capture information to manage AT and AF even when the arrhythmias are not accompanied by symptoms,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division.

Cardiovascular Credentialing International Maintains Accreditation for Four Credentialing Programs and is Awarded Additional ANSI/ISO/IEC 17024 Accreditations

Cardiovascular Credentialing International (CCI) announced that on December 13th, 2011, the Personnel Certification Accreditation Committee (PCAC) of the American National Standards Institute (ANSI) met and took actions on the results of CCI’s 2011 annual surveillance report. The PCAC supported the assessors’ recommendation to grant CCI continued accreditation for the following four credentialing programs: Registered Cardiovascular Invasive Specialist (RCIS), Registered Cardiac Electrophysiology Specialist (RCES), Registered Cardiac Sonographer (RCS), and the Registered Vascular Specialist (RVS). CCI gained ANSI/ISO/IEC 17024 accreditation for these credentialing programs in 2008.

ANSI’s PCAC also approved the assessors’ recommendation to expand CCI’s accreditation scope to include the following four credentialing programs:

  • Certified Cardiographic Technician (CCT)
  • Certified Rhythm Analysis Technician (CRAT)
  • Registered Congenital Cardiac Sonographer (RCCS)
  • Registered Phlebology Sonographer (RPhS)

“To gain and maintain ANSI/ISO/IEC 17024 accreditation is an achievement,” states CCI’s Board President Doug Passey, RCES, RCIS, FSICP, “and 17024 accreditation represents the world’s highest standards as they pertain to personnel credentialing bodies who administer valid credentialing programs.”

About CCI

CCI is a not-for-profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI began credentialing cardiovascular professionals in 1968. The CCI Board of Advisors is comprised of representatives nominated by the following organizations to represent their cardiovascular specialty field: American College of Cardiology (ACC), American College of Phlebology (ACP), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Diagnostic Medical Sonography (SDMS), Society of Invasive Cardiovascular Professionals (SICP), and the Society for Vascular Ultrasound (SVU).

About ANSI

The American National Standards Institute (ANSI) has served in its capacity as administrator and coordinator of the United States private sector voluntary standardization system for more than 90 years. ANSI was founded in 1918 by five engineering societies and three government agencies. The Institute remains a private, nonprofit membership organization supported by a diverse constituency of private and public sector organizations. ANSI is the official U.S. representative to the International Organization of Standardization (ISO).

If you would like more information about this topic, please visit www.cci-online.org or contact CCI Director of Communications, Christine Johnson, at 800-326-0268 or by email at cjohnson@cci-
online.org.