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LifeWatch Services, Inc. and Perminova Announce Device Integration for Cardiac Procedures

LifeWatch, the leading wireless cardiac monitoring service provider in the United States, has launched a strategic alliance with Perminova, a developer of web-based information systems for cardiology centers, to expand interoperability between medical monitoring devices and information technology in cardiac electrophysiology.

Under the arrangement, Perminova EP, the information system designed for electrophysiology, will integrate reports from LifeWatch’s cardiac monitoring and telemetry products directly into Perminova’s cloud-based system. This will provide physicians, nurses, technologists and other staff with a single source for patient information. Future development will also allow clinicians to order LifeWatch cardiac monitoring studies directly from Perminova systems.

The integration process begins with data uploading from a patient prescribed with one of LifeWatch’s suite of advanced ambulatory cardiac telemetry and standard cardiac event monitors to the LifeWatch data center. The LifeWatch data center then pushes the data to Perminova’s database to be matched with patients’ individual files. From there, the data is used by EP lab clinicians and becomes part of the health system’s electronic medical record. This entire process is electronic, greatly reducing the risk of human error.

“The strategic relationship between Perminova and LifeWatch creates important benefits for patients and healthcare systems,” said Craig K. Collins, President and CEO of Perminova. “On a daily basis, it will streamline workflow and improve patient safety in cardiac procedures. In a larger sense, medical device integration between Perminova and LifeWatch creates true interoperability, one of the primary objectives in the advancement of health information technology today.”

Said Dr. Yacov Geva, Chairman and CEO of LifeWatch AG: “Integration between medical devices and information systems is a critical next step in utilizing technology to improve patient health and safety. Medical device integration may also help relieve doctors, nurses and technologists of the burden of creating hard copy documentation, allowing them to spend more time on direct patient care.”

Clinical Results by Twelve Electrophysiologists at Eight Independent U.S. Sites Replicate the Acute Results of the CONFIRM Trial

Topera Medical announced the completion of initial independent clinical cases utilizing the company’s RhythmView 3D mapping system for identifying the specific sources that drive and sustain atrial fibrillation (AF). Twelve electrophysiologists at eight sites across the U.S. evaluated the RhythmView system in more than 30 patients suffering from paroxysmal, persistent and longstanding persistent AF. Three-dimensional FIRMaps produced by the RhythmView system enabled clinicians to identify in all patients the sources of AF, such as rotors and focal beats. Multiple simultaneous sources were identified in the majority of cases.

“These outcomes from independent labs validate the CONFIRM* study findings published last year that first reported the potential for the RhythmView system to improve the diagnosis and treatment planning of arrhythmias,” said Ruchir Sehra, MD, Chief Medical Officer of Topera Medical.

“RhythmView has now demonstrated its robust capabilities in more than 150 patients, while replicating the acute results observed in the CONFIRM trial in these additional 30 patients. Rotors or focal beats have been accurately identified in nearly 100 percent of all AF patients mapped by the system, providing valuable insight to support the electrophysiologist in therapeutic treatment planning.”

Topera is in advanced stages of RhythmView physician preference testing and expects to complete the current phase in the third quarter of 2012 as part of its preparation for commercialization in 2013.

Additional results from the use of RhythmView in a variety of arrhythmias were presented at the Heart Rhythm Society meeting in Boston.

Topera Medical has developed the RhythmView, 3D analysis and mapping system to assist electrophysiologists in the identification of the electrical source of complex cardiac arrhythmias. The RhythmView system, including the RhythmView console and FIRMap™ catheter, is designed to improve patient outcomes by enabling electrophysiologists to view a dynamic representation of the electrical activity of the heart, supporting the diagnosis of and treatment planning for a variety of arrhythmias including atrial flutter, atrial tachycardia, ventricular tachycardia, and AF. The RhythmView 3D mapping system has been cleared for use by the FDA. The FIRMap catheter is in development and is not available for sale.

* CONFIRM (Conventional Ablation with or without FIRM [Focal Impulse and Rotor Modulation]) was an independent, NIH-sponsored study that enrolled 103 individuals from ages 40 to 82 years old (67% persistent AF, 33% paroxysmal). This data was presented at the Heart Rhythm Society, 2011 Scientific Sessions, May 2011, in San Francisco, CA.

First ICD Implantation Performed on Patient in BIOTRONIK’s ESCAPE-ICD Registry in Latin America

BIOTRONIK announced that the first ICD implantation has been performed on a patient enrolled in the BIOTRONIK ESCAPE-ICD Registry in Latin America.

ESCAPE-ICD is a large-scale observational study sponsored by BIOTRONIK and is designed to tackle the alarming lack of data on sudden cardiac death in Latin America.

“The aim of the ESCAPE-ICD registry is to evaluate the size of the Latin American population at risk of sudden cardiac death and to collect clinical evidence so that we can provide primary prevention information to physicians,” said Dr. William Uribe, Principal Investigator of the Study.

'Despite sudden cardiac death being a major cause of death worldwide,1 there is little epidemiological data about its prevalence in the countries involved in the registry: Argentina, Brazil, Colombia, Chile, Mexico and Venezuela. 

The massive scale and scope of this undertaking has been defined in line with BIOTRONIK’s ambition to lead the industry in clinical excellence by providing answers in the most important areas of cardiovascular research and thereby optimizing therapies for cardiovascular patients.

“We are delighted to be taking part in the ESCAPE-ICD registry and to have performed the first ICD implantation on a patient who was at risk of sudden cardiac death. This registry has been long awaited, and we anticipate that we will be able to gather more data to help us address and prevent the problem of sudden death in our patients,” said Dr. Luis E. Aguinaga, Clinical Cardiac Electrophysiologist at Private Center of Cardiology (Centro Privado de Cardiología) in Tucumán, Argentina.

The study consists of two stages: the first will include 12,500 patients in order to evaluate the prevalence of patients at risk and the second stage will be used to compare patients who are only taking medical treatment with patients who have had an ICD implanted.

Dr. Sergio J. Dubner, Principal Investigator of the Study, commented, “Primary prevention of sudden cardiac death is a subject that is long overdue to come to the forefront in Latin America. It’s a great scientific challenge to identify patients at high risk of sudden cardiac death and analyze their incidence, their geographical distribution, and existing differences with other areas in the world. BIOTRONIK’s ESCAPE ICD registry will help provide physicians in Latin America the necessary data to identify patients and provide the best possible treatment.”

ESCAPE-ICD Steering Committee

  • Principal Investigators: Dr. Sergio J. Dubner, MD, FACC, Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio, Buenos Aires, Argentina, and Dr. William Uribe, MD, CES Cardiología, Medellin, Colombia
  • Clinical Advisor: Dr. Francisco J. Alzueta Rodriguez, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
  • Statistics: Dr. Javier Zamora, Universidad Complutense de Madrid, Madrid, Spain
  1. World Health Organization fact sheet No 317, www.who.int

Non-Surgical Procedure Offers Patients with Atrial Fibrillation Who Cannot Take Blood Thinners an Alternative for Stroke Reduction

Patients with atrial fibrillation (AF) who cannot take blood thinners now have an alternative to reduce their risk of stroke, which is five times more common in people with the rhythm disorder. The non-surgical procedure works by tying off the left atrial appendage (LAA), the source of most blood clots leading to stroke in patients with AF. Northwestern Medicine® heart rhythm specialists from the Bluhm Cardiovascular Institute were the first to perform this procedure in Illinois.

“Traditionally, surgery was required to close off the LAA. Now we have the ability to safely and permanently close it using a minimally invasive, non-surgical approach,” said Brad Knight, MD, medical director of the Center for Heart Rhythm Disorders at the Bluhm Cardiovascular Institute. “This is an innovative method that has the potential to revolutionize the field of stroke prevention in patients with cardiac rhythm disorders.”

The procedure, known as LAA occlusion, is performed using the FDA-approved LARIAT® Suture Delivery Device. Doctors access the LAA by inserting a catheter under the rib cage into the sac around the heart through which the suture to tie off the LAA is delivered. Another catheter is advanced through a blood vessel in the groin up into the heart, and positioned inside the LAA to help guide the suture over the LAA. The outpatient procedure eliminates the number one source of heart-related stroke, while avoiding the potentially serious side effects associated with blood thinners.

“We are happy to be able to give our patients another option. Non-surgical procedures mean less discomfort and a shorter recovery time,” said Albert Lin, MD, associate medical director of Cardiac Electrophysiology at the Bluhm Cardiovascular Institute. “Drug therapies have historically been the first line of defense for patients with AF, but they are not tolerated by all patients and can pose serious side effects for some. Now, we have the ability to safely and permanently close the LAA without the need for major surgery and potentially protect against the risk of stroke.”

AF-related deaths have increased over the past two decades and now account for one-quarter of all strokes in the elderly.

“There has recently been a renaissance in the treatment of atrial fibrillation. This latest technological advance represents yet another novel approach to treat atrial fibrillation,” said Clyde Yancy, MD, chief of the Division of Cardiology and associate director of the Bluhm Cardiovascular Institute.

“This is a great option for patients with AF who are at high risk for stroke but cannot safely take blood thinners,” said Knight. “The procedure is non-invasive and the recovery time is short, so patients are able to return to their daily activities quickly.”

Northwestern Medicine® is the shared vision that joins Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine in a collaborative effort to transform medicine through quality healthcare, academic excellence and scientific discovery.

St. Jude Medical Announces FDA Approval of Assura Implantable Defibrillators with Features that Reduce Inappropriate Shocks

St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of its Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new implantable defibrillators feature SecureSense RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices.

“The Assura product portfolio offers new features that protect patients from unnecessary defibrillation therapy,” said Mark A. Coppess, MD, at The Stern Cardiovascular Foundation in Memphis, TN.  “The SecureSense RV Lead Noise Discrimination algorithm is important because it provides a way to distinguish oversensing due to lead issues from real episodes that warrant lifesaving treatment.”

The SecureSense RV Lead Noise Discrimination algorithm is expected to assist physicians by providing advanced alerts as well as more proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise (over-sensing of electrical signals). The technology differentiates lead noise from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes that require lifesaving therapy.

In addition, ShockGuard technology features specific programming that distinguishes between rhythms that require defibrillation therapy and those that do not, such as benign arrhythmias. DecisionTx programming offers advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high-voltage shocks. Using ShockGuard with DecisionTx programming, 98.5 percent of patients are projected to be free of inappropriate shocks after one year.1

“For some patients, the fear of receiving a shock can either prevent them from receiving a potentially lifesaving device, or cause anxiety that reduces their quality of life once they receive the device. These devices directly address this patient concern and provides physicians additional tools to manage individual patient needs,” said Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division.

The Assura family of devices will allow St. Jude Medical to continue to offer industry-leading 40 J in delivered energy, in addition to TailoredTherapy features that give physicians more options for customizing therapy for patients, such as DeFT Response Technology. The DeFT Response Technology feature is designed to meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of lifesaving therapy. The Assura product portfolio includes the Quadra Assura CRT-D, the Unify Assura CRT-D and the Fortify Assura ICD.

  1. Daubert JP, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II: Frequency, Mechanisms, Predictors, and Survival Impact. JACC 2008;51(14):1357-1365.

Boston Scientific Announces FDA Approval and First U.S. Implant of New Devices to Treat Bradycardia

Boston Scientific Corporation announces U.S. Food and Drug Administration (FDA) approval and market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P). The first implant of the INGENIO pacemaker in the U.S. was performed on May 3 by Bruce L. Wilkoff, MD, Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic.

The INGENIO and ADVANTIO pacemakers feature RightRate pacing technology designed to treat chronotropic incompetence (CI). CI is the inability of the heart to regulate its rate appropriately in response to physical activity, which may cause patients to feel tired or short of breath during daily activities such as walking or climbing stairs. RightRate employs Boston Scientific’s minute ventilation (MV) sensor, the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.

“Matching the patient’s need to increase their heart rate with their precise activities is the main goal of cardiac pacing,” said Dr. Wilkoff, who has authored numerous articles on chronotropic response and rate adaptive pacing. “Achieving that match depends on having the right tools such as an MV sensor and intelligent programming.”

In addition to RightRate, the INGENIO pacemaker offers Respiratory Rate Trend (RRT), an exclusive feature that monitors respiration — a key vital sign. The INVIVE CRT-P offers RRT as part of HF Perspectiv — a comprehensive suite of heart failure diagnostics designed to provide health care professionals with additional information to guide treatment decisions.

“We are very pleased to receive FDA approval for these advanced devices, and excited about the potential they bring to our bradycardia business. With these products, Boston Scientific embarks on a new era in pacing technology,” said Joe Fitzgerald, senior vice president and president of the Boston Scientific Cardiac Rhythm Management group.

The INGENIO, ADVANTIO and INVIVE devices are designed for use with Boston Scientific’s new LATITUDE NXT Remote Patient Management system, which is currently under review by the FDA, and will enable physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and heart health status. The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology using AT&T’s wireless network, under an agreement between Boston Scientific and AT&T.

In April, the company announced CE Mark approval and European market launch of the INGENIO and ADVANTIO pacemakers and INVIVE CRT-P.

Biosense Webster Announces Launch of the ThermoCool® SF NAV Catheter with Curve Visualization

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the new ThermoCool® SF NAV irrigated ablation catheter with Curve Visualization in the United States.

New Curve Visualization Technology

The ThermoCool® SF NAV Irrigated Ablation Catheter with Curve Visualization combines Biosense Webster’s latest porous tip technology with the accurate visualization of the Carto® 3 3D Mapping & Ablation System. This enhanced technology is designed to reduce fluoroscopy exposure to physicians, lab staff and patients alike, enhance visualization of the ablation catheters orientation and improve procedural efficiency.

Dr. Daniel Melby, Cardiac Electrophysiologist from the Minneapolis Heart Institute in Minneapolis, MN, was among the first to use the new technology in the United States. “The ThermoCool® SF Catheter with Curve Visualization provides substantial advantages over existing technologies. While using the Curve Visualization feature, the catheter position is more completely represented on the Carto display, thereby allowing less fluoroscopy use and easier catheter positioning on difficult atrial locations. In addition, the ThermoCool® SF Catheter platform provides the ability to consistently ablate at all atrial locations without the limitation of overheating and with 50% less volume delivery to the patient.”

Porous Tip Technology

Since its introduction in January 2012, the ThermoCool® SF Catheter with Surround Flow technology has achieved widespread adoption within hundreds of hospitals throughout the United States.

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.

The ThermoCool® SF NAV Catheter is approved in the United States for 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.

About AF and Cardiac Ablation

Atrial fibrillation (AF) 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. Today, most patients with AF are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs

Cardiac ablation offers a safe and efficacious alternative to treat cardiac arrhythmias. 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).

Dr. Melby is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.