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Biosense Webster Enrolls First Patient in Groundbreaking SMART-AF Trial
Biosense Webster, Inc. announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.
The SMART-AF study is designed to demonstrate the safety and effectiveness of ThermoCool® SmartTouch™, the latest addition to the market-leading and FDA-approved NaviStar® ThermoCool® Catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enroll up to 164 patients in leading centers across the United States.
The ThermoCool® SmartTouch™ Catheter is one of the most advanced catheters developed by Biosense Webster to date. During cardiac ablation procedures, the ThermoCool® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. This information is graphically displayed on the Carto® 3 Mapping and Navigation System, the most advanced 3D Mapping System available on the market today, via the novel Carto® 3 SmartTouch™ Module, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities.
Performing the first case, Dr. Andrea Natale, Executive Medical Director of Texas Cardiovascular Arrhythmia Institute at St. David’s Medical Center, and a leading researcher in this area said, “The ThermoCool® SmartTouch™ Catheter is a breakthrough technology in the field of electrophysiology. It provides me with new contact force information during AFib ablations. I look forward to further evaluating this technology in the SMART-AF study,” he concluded.
The ThermoCool® SmartTouch™ Catheter combines Biosense Webster’s irrigated ablation technology and the accurate visualization the Carto® 3 System is renowned for globally, with force-sensing capabilities. By displaying precise contact force and direction information, the ThermoCool® SmartTouch™ Catheter provides an added parameter for the mapping and ablation of complex cardiac arrhythmias, such as atrial fibrillation.
“The ThermoCool® SmartTouch™ Catheter brings important new contact force information to physicians when performing cardiac ablation. This breakthrough technology continues our commitment to bringing advanced tools to the Cardiac Electrophysiology community, so that they may better serve their patients,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.
About AF and Cardiac Ablation
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 100,000 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 the standard of care for “simple” arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. Biosense Webster’s NaviStar® ThermoCool® irrigated ablation catheter remains the only FDA-approved radiofrequency navigation catheter for the treatment of symptomatic drug refractory atrial fibrillation on the market today.
Editor Note: Dr. Natale is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.
Coronary Artery Disease is an Independent Predictor for Early Atrial Fibrillation Development Following Heart Attack
Results from a case control study show that coronary artery disease affecting the atrial branches is an independent predictor for new-onset atrial fibrillation (AF) after acute myocardial infarction (MI), or heart attack. The study, published in the July edition of HeartRhythm, the official journal of the Heart Rhythm Society, evaluated the characteristics associated with the development of new-onset AF in a cohort of consecutive patients with acute MI. The study also considered the impact of the potential role of factors such as age, presences of left ventricular (LV) dysfunction, and left atrial (LA) enlargement and found that atrial branch disease was an independent risk of developing AF after MI.
The study consisted of 2,460 consecutive patients with acute MI presented to a single university hospital between 2004 and 2009. Of the 2,460 patients who were admitted with MI during the study period, 149 (6 percent) developed AF within the first week. In total, 42 cases were identified as subjects who developed new-onset AF during the first week post-MI. The control group consisted of 42 MI patients without AF who were matched to cases for age, sex and left ventricle (LV) ejection fraction from the same cohort of patients and had undergone both coronary angiography and echocardiography.
Results showed that patients with new-onset AF had a higher proportion of inferior MI, more than 85 percent. In multivariate analysis, right coronary atrial branch disease (66.7 percent) and left circumflex atrial branch disease (59.5 percent) were predictors of new-onset AF during the first week post-MI, after adjustments. In addition, right coronary artery disease was a characteristic of more than 71 percent of new-onset AF patients. Overall, observation from the case control study reveals coronary artery disease affecting the atrial branches is a predictor for the development of AF early after MI.
“With the angiographic data and echocardiographic findings, our results provide novel insight into the mechanisms underlying the development of AF in patients after they experience a heart attack,” stated senior author Prashanthan Sanders, MBBS, PhD, at the Royal Adelaide Hospital in Australia. “The findings shed new light on how coronary disease affects the atrial branches after the trauma of a heart attack regardless of measurable effects such as a patient’s gender or age.”
Previous studies have shown inconsistent and conflicting data regarding associations in MI and new-onset AF. The study determined coronary artery disease affecting the atrial branches to be a predictor of new-onset AF independent of measurable effects of age, gender, LV ejection fraction and several other factors.
For more information about this study, please visit www.heartrhythmjournal.com.
Medtronic To Acquire PEAK Surgical, Inc.
Medtronic, Inc. announced that it has entered into a definitive agreement to acquire PEAK Surgical, Inc., a recognized leader in the emerging field of advanced energy surgical incision technology to broaden Medtronic Surgical Technologies’ portfolio of innovative surgical products to meet customer and patient needs worldwide.
The total value of the transaction is $120 million. Medtronic had previously invested in PEAK and currently holds an ownership stake in the company. Net of this ownership stake, the transaction value is approximately $105 million. PEAK's revenue is annualizing at approximately $20 million and is growing rapidly.
PEAK Surgical, Inc. specializes in surgical instruments based on its proprietary PlasmaBlade® technology, which represents an important advancement in advanced energy surgical technologies. The PEAK PlasmaBlade® consists of a family of disposable cutting devices with proprietary insulation technology that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery with minimal thermal tissue damage. PEAK’s technology is cleared for use in a variety of settings, including Ear, Nose and Throat (ENT), plastic reconstructive, orthopedic and general surgical applications.
The addition of the PEAK PlasmaBlade® surgical solutions will help Medtronic serve doctors and patients and continue to fulfill the Medtronic mission of alleviating pain, restoring health and extending life.
“We are excited about this opportunity to bring our companies together and further broaden Medtronic Surgical Technologies’ portfolio of innovative surgical products to meet customer and patient needs worldwide,” said Chris O’Connell, executive vice president and president of Medtronic’s Restorative Therapies Group. “PEAK’s advanced energy cutting technologies complement our existing surgical product line, strengthening our core offerings and enabling us to offer surgeons and patients a full spectrum of leading products across the entire surgical continuum.”
John Tighe, president and CEO of PEAK Surgical, Inc., added, “Medtronic’s global reach will allow more patients and hospitals to benefit from the proven clinical and economic benefits associated with our PlasmaBlade® technology. We are excited to join Medtronic and by the potential to further develop our family of products in multiple surgical specialties.”
In a separate development, Medtronic announced it has signed an agreement to acquire Salient Surgical Technologies, Inc., another leader in advanced energy surgical technology, particularly in the area of advanced hemostatic sealing products. Together, these acquisitions represent Medtronic’s commitment to innovation across the entire surgical continuum from incision to closing, and represent entries into new areas such as plastic/reconstruction, electrophysiology, oncology and large bone orthopedics.
The acquisition is subject to governmental and regulatory review in the U.S. and several countries. Until the transaction is cleared and closed, the companies will continue to operate as separate entities.
PEAK Surgical, Inc. is a medical device company that has developed the PEAK PlasmaBlade®, a new tissue dissection device based on a proprietary technology that represents an important advance in radiofrequency surgical technologies. The PlasmaBlades are a family of disposable cutting devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage. These surgical devices come together with the PULSAR® Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlades, to form the PEAK® Surgery System. The PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States, and for use in general surgery in the EU. In the United States, the PEAK Surgery System was launched in July 2008 and has been used by U.S. surgeons on more than 25,000 patients.
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology — alleviating pain, restoring health and extending life for millions of people around the world.
Vasomedical Receives FDA 510(k) Clearance on Two Additional BIOX™ Monitors
Vasomedical, Inc., a leader in the sale of diagnostic imaging products through its wholly-owned subsidiary, VasoHealthcare, as well as a leader in the technology for non-invasive treatment and management of cardiovascular diseases, announced its receipt of the U.S. FDA 510(k) clearance to market its Vasomedical-BIOX™ Model 1303 3-channel ECG Holter Monitor and Model 1304 12-channel ECG Holter Monitor. These new BIOX™ models, together with the company’s already FDA-cleared Model 1305 3-channel ECG Holter Monitor, Model 1804 Ambulatory Blood Pressure Monitor and 2300 Series Combined ECG Holter/Ambulatory Blood Pressure Monitors, form a complete line of ambulatory monitoring products for long-term recording and analysis of ECG and blood pressure data, offering flexible solutions to clinicians for various diagnostic needs. All Vasomedical-BIOX™ series monitors work with the CB Series Analysis Software, also previously cleared by the U.S. FDA.
Ambulatory ECG and blood pressure data provide important information about incidental cardiovascular abnormalities that are often not observable during a visit to the physician’s office, and are therefore extremely valuable for early diagnosis of the ever-increasing cardiovascular diseases. Vasomedical’s BIOX™ brand ambulatory monitoring products, including the 1300 Series ECG Holter monitors, 1800 Series ambulatory BP monitors and 2300 Series combined ECG Holter/ABP monitors, are easy for clinicians to use, comfortable for patients to carry, and are all priced competitively. The newly cleared ultra compact Model 1303 ECG Holter Monitor is among the world’s smallest and lightest, with an LCD display for real-time viewing of recorded information.
“It is an exciting development that we received U.S. FDA clearances of four BIOX™ series products within a week,” commented Dr. Jun Ma, President and CEO of Vasomedical. “We are achieving our goal of building a portfolio of complementary products to address the growing needs of the medical market. Together with its core technology of Enhanced External Counterpulsation (EECP®) therapy systems, the company has strategically positioned itself for growth as a full solutions partner to the global cardiac marketplace that demands the best in products, technology, support and innovation.” Vasomedical will exhibit all BIOX™ series products and the Lumenair EECP® system at the upcoming Florida International Medical Expo (FIME) in Miami Beach, Florida, August 10–12, 2011, the European Society of Cardiology (ESC) Congress in Paris, France, August 27–30, 2011, as well other major global events, including those sponsored by the American College of Cardiology (ACC), American Heart Association (AHA), American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and the Heart Failure Society of America (HFSA).
About Vasomedical
Vasomedical, Inc. is engaged in designing, manufacturing, marketing and supporting EECP® external counterpulsation systems based on the company's proprietary technology. EECP® therapy is a non-invasive, outpatient therapy for the treatment of cardiovascular diseases and is currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The company provides hospitals, clinics and private practices with EECP® equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. The company also provides other noninvasive medical equipment including Holter monitors and ambulatory blood pressure monitors.
Vaso Diagnostics d/b/a VasoHealthcare, a wholly owned subsidiary of Vasomedical, Inc., is a professional sales representation organization offering vendors of medical devices an alternative third party sales channel. Through an agreement with GE Healthcare, it is currently engaged as an exclusive sales representative for certain GE Healthcare products.
Endosense Reports Completion of First Patient Case Utilizing Contact-Force Visualization Software, Developed in Cooperation with Siemens
Endosense, a Swiss medical technology company, has announced completion of the first patient case utilizing prototype software that integrates the contact-force data provided by Endosense’s TactiCath® force-sensing ablation catheter1 with Siemens Healthcare’s electrophysiology solutions. Performed by Dipen Shah, MD, on June 15 at the University Hospital of Geneva, this procedure demonstrated the feasibility of the companies’ jointly developed application for use during the catheter ablation treatment of cardiac arrhythmias. The new software was designed to give electrophysiologists access to contact force information in a fluoroscopically enabled, three-dimensional anatomic heart model with X-ray based catheter tracking system.
“This new contact-force visualization software brings a valuable new sensory dimension to the catheter ablation procedure, as we can now measure, control and also virtually see in 3D the contact forces we apply as we are applying them,” said Dr. Shah. “I believe this new level of visualization will not only make the procedure more intuitive and easier for electrophysiologists to perform, but it will also allow us to improve our ablation technique in such a way that we ultimately offer safer and more effective procedures.”
Eric Le Royer, chief executive officer, Endosense, also commented on the software’s potential. “This first successful patient case is a significant achievement that moves us closer to our goal of offering electrophysiologists the benefits of contact-force sensing in new and value-added platforms. We look forward to our continued partnership with Siemens as we work to take this disruptive software from prototype to commercial stage.”
Martin Ostermeier, Director of Innovations of the Interventional X-ray business unit of Siemens Healthcare, added, “The amount of information electrophysiologists have to deal with during ablation procedures is huge. Finding elegant ways to present sensor values like contact force in a 3D image context may help to make a real difference.”
1Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.
Healthy Lifestyle Associated With Low Risk of Sudden Cardiac Death in Women
Adhering to a healthy lifestyle, including not smoking, exercising regularly, having a low body weight and eating a healthy diet, appears to lower the risk of sudden cardiac death in women, according to a study in JAMA.
“Sudden cardiac death (SCD) [defined as death occurring within one hour after symptom onset without evidence of circulatory collapse] accounts for more than half of all cardiac deaths, with an incidence of approximately 250,000 to 310,000 cases annually in the United States,” the authors write as background information in the study. The authors also note that no prior studies have examined the combination of multiple lifestyle factors and risk of SCD.
Using data collected as part of the Nurses’ Health Study, Stephanie E. Chiuve, Sc.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues examined the association between a healthy lifestyle and risk of SCD. A total of 81,722 women who participated in the Nurses’ Health Study from June 1984 to June 2010 were included in the study, and lifestyle factors were assessed via questionnaires every two to four years. A low-risk lifestyle was defined as not smoking, having a body mass index (BMI) of less than 25, exercise duration of 30 minutes/day or longer, and consuming a diet closely related to a Mediterranean-style diet (emphasizes high intake of vegetables, fruits, nuts, legumes, whole grains and fish, with moderate alcohol intake).
During the 26 years of follow-up, there were 321 cases of SCD among women (average age 72 years at the time of the SCD event) in the study. All four low-risk factors were significantly and independently associated with a lower risk of SCD. Not smoking, exercising and eating a healthy diet each were inversely associated with risk of SCD. BMI also was associated with the risk of SCD, with women having a BMI between 21 and 24.9 at lowest risk.
Women at low risk for all four lifestyle factors had a 92 percent lower risk of SCD when compared with women at low risk for none of the four lifestyle factors.
“The primary prevention of SCD remains a major public health challenge because most SCD occurs among individuals not identified as high risk,” the authors write. “In this cohort of female nurses, adherence to an overall healthy lifestyle was associated with a lower risk of SCD and may be an effective strategy for the prevention of SCD.” (JAMA. 2011;306[1]62-69.)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
20,000 Patients Successfully Implanted with AIGISRx® Antibacterial Envelope for Pacemakers and Defibrillators
TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with implantable pacemakers and defibrillators, announced that it has successfully implanted its AIGISRx® Antibacterial Technology in 20,000 patients in the United States.
Implantation of cardiac implantable electronic devices (CIEDs) for permanent pacing, heart failure therapy, and prevention of sudden cardiac death exceeds 500,000 annual cases in the United States and is associated with a major infection rate from 0.5–7%.
“As the number of patients at risk for serious CIED-related infections continues to increase, it is reassuring to know that there is a product like the AIGISRx Antibacterial Envelope that can help improve patient outcomes by reducing infection and the cost of treating infection,” remarked Grant Simons, MD, FACC, Director of Cardiac Electrophysiology, Englewood Hospital and Medical Center, Englewood, New Jersey.
“TYRX is very proud to announce the successful implantation of 20,000 AIGISRx devices,” stated Robert White, TYRX Chief Executive Officer. “We view this key milestone as an indication that the cardiac care community support for the AIGISRx technology is continuing to increase.”
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug/device products focused on infection control, including the AIGISRx® Antibacterial Envelope and AIGISRx® Flat Sheet products. AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker- and defibrillator-related endocarditis, including “superbugs” or MRSA*. Following commercial release, the AIGISRx Envelope has been implanted in over 20,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2011 will receive an AIGISRx product during their procedure.
TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009;32(7):898-907.
Pitt Researchers Find New Way to Classify Post-Cardiac Arrest Patients, Improving Ability to Predict Outcomes
A new method for scoring the severity of illness for patients after cardiac arrest may help to predict their outcomes, according to researchers at the University of Pittsburgh School of Medicine. Most importantly, their findings, published in the early online version of Resuscitation, also show that none of the severity categories rules out the potential for a patient’s recovery.
“Traditionally, we have used historical or event-related information, such as initial cardiac rhythm or whether someone witnessed the collapse, to categorize these patients upon arrival at the hospital,” said Jon C. Rittenberger, MD, lead author and assistant professor of emergency medicine. “Unfortunately, more than 10 percent of the time, such information is unavailable, which limits our ability to tailor therapies, counsel families about prognosis or select patients for clinical trials.”
Cardiac arrest is the most common cause of death in North America, resulting in approximately 350,000 deaths each year.
The researchers looked at retrospective data for more than 450 post-cardiac arrest patients treated at UPMC Presbyterian between January 2005 and December 2009. Both in-hospital and out-of-hospital cardiac arrests were included. In 2007, the hospital implemented a multi-disciplinary post-cardiac arrest care plan, including therapeutic hypothermia, or cooling of patients to minimize brain damage.
Four distinct categories of illness severity were identified based on a combination of neurological and cardiopulmonary dysfunction during the first few hours after restoration of a patient’s spontaneous circulation. The researchers looked at rates of survival, neurologic outcomes and development of multiple organ failure for patients in each category, and found wide variations among the groups.
“Now, objective data available to the clinician at the bedside during initial evaluation may provide a better way of predicting outcomes and guiding the decisions of families and clinicians. We found that the category of illness severity had a stronger association with survival and good outcomes than did such historically used factors as initial rhythm of arrest or where it happened,” said Dr. Rittenberger. “Our results indicate that illness severity should be carefully measured and accounted for in future studies of therapies for these patients.”
Co-authors of the study include Samuel A. Tisherman, MD, Margo B. Holm, PhD, Francis X. Guyette, MD, MPH, and Clifton W. Callaway, MD, PhD, all of the University of Pittsburgh.
The research was supported by a grant from the National Center for Research Resources. Dr. Rittenberger is also supported by an unrestricted grant from the National Association of EMS Physicians/Zoll EMS Resuscitation Research Fellowship.
