Industry News & Products

St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.

St. Jude Medical, Inc. announced the first implant of its Current® Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system. The St. Jude Medical SJ4 connector reduces the number of connections between the device and the wires (defibrillation leads) that send electrical impulses to the heart, which is intended to enable a streamlined implant procedure. The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device. "With only a single connection and one set screw, the SJ4 connector has the potential to improve the implant procedure, may reduce the lead volume under the ICD in the chest wall and may improve patient comfort," said Cleveland Clinic's Bruce Wilkoff, MD, who is on the company's physician lead review board and has sponsored research with St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD with SJ4 connector on June 4, 2009. "This design is intended to reduce the risk of incorrect connections of the lead to the ICD and reduce procedure time." The St. Jude Medical SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization (ISO) but will not be labeled as such until the standard is finalized, which is expected later this year. St. Jude Medical began launch of the SJ4 connector system after ISO-directed interchangeability testing among multiple manufacturers was completed. This testing was deemed an important step in ensuring that these new leads, which currently meet the drafted IS-4 standard, would be compatible with future implanted devices. "Simplifying the lead connection process is one of many design features we have incorporated as part of our commitment to making procedures safer for patients and more efficient for physicians, from implant through follow-up," said Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. "This aligns with our strategy of reducing lead risks and increasing reliability, which includes technology designed to reduce lead-to-can abrasion and sensing of far-field ventricular signals in the atrium." The Current Plus ICD was approved by the FDA in April 2009, along with the company's Promote® Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata® SJ4 defibrillation lead. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim® insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation. Both devices are built on the St. Jude Medical Unity platform, a consolidated hardware and software unified device interface, and include advanced safety features and algorithms for improved patient management, including TailoredTherapy™ features that allow physicians to customize therapy to individual patient needs. The devices also feature improved lead monitoring capabilities, including daily checks of all pacing and shock configurations, and have the ability to inform the patient's clinic, via the St. Jude Medical Merlin@home® transmitter and Merlin.net™ Patient Care Network (PCN), of any critical system changes. As a requirement for FDA approval, St. Jude Medical is conducting a post-approval study featuring the SJ4 connector that will enroll up to 1,700 patients and follow them for five years. The company will also be gathering data on this new connector system as part of its ongoing SCORE patient registry, designed to track long-term data on system performance for all products, including new technology. ___________________________

AF AWARE Cardiology Groups Call for Greater Awareness and Better Education on Atrial Fibrillation

Four leading patient and medical associations announced the formation of AF AWARE (Atrial Fibrillation AWareness And Risk Education), a joint initiative to highlight and address issues that contribute to the growing burden of atrial fibrillation (AF) worldwide. Marking the start of World Heart Rhythm Week, the World Heart Federation (WHF), Atrial Fibrillation Association (AFA), Stroke Alliance For Europe (SAFE), and European Heart Rhythm Association (EHRA) have come together to call upon their peers around the world to raise awareness and understanding of AF and its cardiovascular complications, such as stroke. AF is the most common cardiac arrhythmia seen by doctors.1 It is a fast growing public health concern currently affecting an estimated seven million people in the USA and Europe alone, and it is expected to double by 2050, reflecting the growing proportion of elderly individuals.1,2 “Patients with AF have a substantially lower quality of life than healthy individuals as a result of their condition. If left untreated, they are at higher risk of experiencing stroke or other cardiovascular complications, which can have serious and debilitating consequences,” said Trudie Lobban, CEO of the AFA. “As AF carries a fivefold increase in the risk of stroke, the risk of death or severe morbidity is considerably increased as well. In addition, patients who have a stroke and have AF often have a worse prognosis compared to patients without AF.” Results from an AF AWARE international survey of more than 1,600 cardiologists and patients in 11 countries confirm that patients need a better understanding of AF, its consequences and management options. Despite the nature and risks of AF, one in four patients in this survey said he or she did not understand and could not explain what AF is and only a third were worried or fearful about having AF. Patients indiscriminately rated all risks of complications as high and confirmed the significant impact of AF on their quality of life and ability to conduct day-to-day activities. “Very few people truly understand the real and significant impact of atrial fibrillation,” said Professor Günter Breithardt, from the WHF. “There is an urgent need for better information for patients. AF AWARE aims to expose the poor understanding of this complex disease and to help healthcare professionals, patients, policy makers and the general public understand that comprehensive management of AF should address its multiple impacts.” The majority of cardiologists (61%) in the survey said their patients needed more and better information on AF: they rated the quality of patient education materials for AF as inferior to that available for other common cardiovascular diseases, heart attack, hypertension, high cholesterol, diabetes and stroke. “AF patients need much better information about their disease, and doctors can play a central role in providing this help,” said Professor Vardas, president-elect of EHRA. “These results indicate that AF patients may feel resigned about living with this illness and its complications. World Heart Rhythm Week and AF AWARE are opportunities for us to come together to improve patients’ experience of living with AF through awareness and education.” 1 Fuster V, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. Eur Heart J 2006;27:1979-2030. 2 Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285:2370-2375. ___________________________

Mayo Clinic Receives $48 Million in Grants to Study Catheter Ablation for Atrial Fibrillation

Mayo Clinic received $48 million in grants from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and from industry to study the treatment of atrial fibrillation (AF) in 3,000 patients and 140 centers around the world. Mayo Clinic is leading the study. The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial is designed to determine whether catheter ablation is more effective than drug therapy for the treatment of AF, says Douglas Packer, MD, the trial's principal investigator and a cardiologist at Mayo Clinic. The study, which will take six years from beginning to releasing results, is a collaborative effort among Dr. Packer and Richard Robb, PhD, at Mayo Clinic, Kerry Lee, PhD, and Daniel Mark, MD, at Duke Clinical Research Institute in Durham, North Carolina, and the NHLBI. Funding for the trial consists of $18 million from NHLBI/NIH, $20 million from St. Jude Medical and $10 million from Biosense Webster. The trial will determine whether left atrial catheter ablation, which involves inserting long, narrow tubes to reach and apply energy (hot or cold) to destroy abnormal heart tissue, to eliminate AF is better than current state-of-the-art drug therapy, Dr. Packer says. The trial also will examine AF recurrence, stroke risk, quality of life and cost-effectiveness. The study will randomize patients over three years, with half undergoing catheter ablation and half receiving rate control or rhythm control drug therapy. According to Dr. Packer, the trial is needed because: • AF is on a rapid rise and particularly increasing in individuals over 60 years of age. • Multiple recent trials have shown the inadequacy of drug therapy to maintain normal heart rhythm and reduce death. • The use of catheter ablation is rapidly increasing, but a large clinical trial such as CABANA is necessary to answer important questions about effectiveness and safety. • AF has a large impact on a patient's quality of life and on health care costs. "While prior trials have investigated the effectiveness of ablation in treating AF, their value in guiding the treatment of patients is limited by the small size of the studies, relatively short follow-up periods, and the exclusion of older patients with more long-standing AF as well as underlying disease. CABANA will include these patients and follow them for a much longer time period to more clearly define optimal therapy for AF," Dr. Packer says. "We believe that CABANA will be a landmark trial that will guide therapy in the atrial fibrillation arena for years to come." Before these grants were awarded, Mayo Clinic led a 10-center, 60-patient pilot study. Those results will be announced later this summer. The CABANA Trial will be conducted as a collaboration between the Heart Rhythm Service and Biomedical Imaging Resource Center at Mayo Clinic, Duke Clinical Research Institute, and CABANA investigators from the 140 centers around the world. Mayo Clinic and Drs. Packer and Robb have a financial interest in a mapping technology that may or may not be used in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical and Mayo Clinic, and Drs. Packer and Robb have received annual royalties greater than $10,000, the federal threshold for significant financial interest. Mayo Clinic and Dr. Robb have a financial interest in Analyze-AVW technology that will be used to analyze some of the heart images in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and both Mayo Clinic and Dr. Robb have received royalties greater than $10,000, the federal threshold for significant financial interest. In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed. ___________________________

Cordex Receives Special Protocol Assessment Approval from FDA for ATPace™

Cordex Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace™ as an antiarrhythmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the Special Protocol Assessment (SPA) process. ATPace™ is a novel stable liquid formulation of adenosine 5’-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. ATP has been used in Europe for more than five decades as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile. Cordex intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace™ in approximately 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a New Drug Application filing of ATPace™ for the treatment of PSVT in emergency room patients. “We are very pleased with the FDA’s decision; we believe that data to be obtained in the proposed trials would constitute sufficient evidence to support the marketing approval of ATPace™ for the proposed indication,” commented Amir Pelleg, PhD, Cordex’s President and CSO. “Due to its unique mechanism of action in the heart, which involves a central vagal reflex and adenosine, the product of its rapid degradation, ATPace™ has the potential to be an important advance in the treatment of patients with PSVT,” he added. ___________________________

Temporary Leadless Pacing Found Successful in Heart Failure Patients

New research proves the feasibility of leadless pacing in heart failure patients with ultrasound-mediated stimulation energy. The new study published in the June edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, sought to apply ultrasound-mediated leadless pacing technology in heart failure patients and to evaluate the effects of respiration and body posture on the acoustic window. The study is the first of its kind to demonstrate successful leadless pacing in human subjects with advanced heart failure. Conducted by a team of researchers at the Queen Mary Hospital in Hong Kong in 2006, ten patients were identified who underwent diagnostic testing with coronary angiography and left ventriculography. Patients who were 18 years or older, had an ejection fraction of less than or equal to 35% and were in New York Heart Association (NYHA) functional class III or IV were eligible to participate. An electrophysiology catheter incorporating a receiver-electrode to deliver ultrasound-mediated pacing was positioned in the left ventricle to determine the thresholds. The acoustic windows on the chest wall were determined based on the effects of respiration while the patients were lying on their back, tilted 30 degrees leftward, rightward and upward. “It was our objective to conduct a study that would demonstrate the feasibility of leadless pacing in patients with advanced heart failure,” said lead author Dr. Kathy L. Lee, MBBS, from the Department of Medicine at the Queen Mary Hospital in Hong Kong. “We believe our study will generate further interest in leadless pacing and encourage future technological advancements in this area.” The results of the study found ultrasound-mediated pacing to be successful in all ten patients who participated, showing a 100 percent success rate. The acoustic window size was adequate for ultrasound transmission from the chest surface to a receiver electrode in the left ventricle, regardless of patient position or respiratory phase. Thus, the ability to perform leadless left ventricular pacing in heart failure patients using the novel technology under development proves to be feasible. Leadless pacing is a potential breakthrough in pacing technology that provides the advantage to avoid all complications related to the insertion and existence of a pacing lead, such as infections and lead dysfunction, which can lead to severe cardiac problems or death. ___________________________

Transoma Medical Receives FDA Marketing Clearance for Exclusive Capability Providing Immediate Access to Critical ECGs on Mobile Handheld Device

Transoma Medical, Inc., manufacturer of Sleuth® and Sleuth AT™, the wireless and automated implantable cardiac monitoring (ICM) systems, has received FDA 510(k) marketing clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient’s Personal Diagnostic Manager (PDM). The PDM is a handheld device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event, making it easier for clinicians to correlate symptoms with rhythms. “Instant access to a patient’s ECG data on the mobile handheld device is a clinically valuable tool in urgent situations, such as when the patient presents in the emergency room,” said Dr. Asim Yunus, an electrophysiologist with Michigan Cardiovascular Institute in Saginaw, Michigan. “Transoma continues to advance cardiac monitoring technology with their devices. The Sleuth systems already provided information much faster and more efficiently than other implantable monitoring options. Now, with Data Review, we don’t even have to wait for the automatic downloads to the monitoring center because the events are right there on the handheld device. This kind of access to information has never been available before.” As a complete, remote and automated system, Sleuth AT offers several advantages. The system includes a small implanted device that incorporates the most sensitive arrhythmia detector of any ICM on the market. Not only does Sleuth AT capture ECG strips containing arrhythmias automatically, it also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center, where certified cardiac technicians review the data and alert clinicians to clinically-significant events, providing a high degree of specificity. And now, with Data Review, ECG recordings that have not yet been transmitted to the monitoring center can be accessed directly on the handheld PDM. “As a device clinic coordinator, it is not uncommon for me to manage data on 2,000 or more patients at a given time from a variety of cardiac monitoring systems,” said Lori Fravel, BSN, CCRN, CCDS, a nurse who supports 10 cardiologists at Mt. Carmel Columbus Cardiology Consultants in Columbus, Ohio. “I have found the Sleuth systems to be extremely efficient because I am only alerted to clinically-significant events and I never have to call the patient to coordinate manual interrogation of his or her device. The setup of the system allows me to get the information I need in a much more streamlined fashion. Now with Sleuth AT, the added benefit of ECG access on the handheld device means any available clinician can view recently captured events without a programmer, even if the patient has been away from home. I am hopeful this will further speed access to critical information.” “With the addition of the Data Review feature, the Sleuth AT system is designed to be an even better and more accurate diagnostic tool that further enhances efficiency for the practice and simplicity for the patient,” said Nestor Jaramillo, Transoma Medical vice president of sales and marketing. “Our goal is to assure that clinicians have access to the right cardiac information at the right time in the simplest and most efficient manner possible. Providing the right information to the physician can lead to faster diagnosis and selection of the right therapeutic regimen for the patient. Everyone can benefit. At Transoma Medical, we believe better treatment starts with better information.” ___________________________

Defibtech, Sudden Cardiac Arrest Association Continue to Donate AEDs in Critical Areas

For the second straight year, Defibtech and the Sudden Cardiac Arrest Association (SCAA) will donate automated external defibrillators (AEDs) to help communities with critical needs to strengthen the “chain of survival” from sudden cardiac arrest, which kills up to 1,000 Americans each day. Announcing the effort during National Cardiopulmonary Resuscitation (CPR) and Automated External Defibrillator (AED) Awareness Week, Defibtech CEO Dr. Glenn W. Laub said the success of last year’s effort was made possible by the initiative of local SCAA chapters and affiliates, which recommended the community organizations that received the AEDs. “These dedicated people make consistent efforts where they matter most,” he said. “They did a great job helping us to place defibrillators where they can make the difference between life and death from sudden cardiac arrest.” Over the past year, the Defibtech/SCAA program provided AEDs to many organizations, including the following through SCAA chapters or affiliates: Austin (Texas) City Hall (SCAA Austin Chapter); Cape Cod (Massachusetts) Challenge Club for children with disabilities (SCAA affiliate Connecting Hearts, Inc.); Urbandale (Iowa) Middle School (SCAA affiliate AED Access for All); Nassau County (New York) Little League Field (SCAA Long Island Miracles Chapter); Salvation Army, Lubbock, Texas (SCAA Lubbock Chapter); Lorain County (Ohio) Fairgrounds (SCAA Northeast Ohio Chapter); DeLagoon Ballpark, Fegus Falls, Minnesota (SCAA Ottertail County Northwest Minnesota Chapter); St. Mary’s Primary School, Taunton, Massachusetts (SCAA Southeast Massachusetts Chapter); Naugatuck (Connecticut) Senior Center (SCAA Southwest Connecticut Chapter); Oakdale Country Club, Mexico, Maine (SCAA affiliate Med-Care Ambulance); Sts. Simon and Jude School, Pittsburgh, Pennsylvania (SCAA Western Pennsylvania Chapter). SCAA Executive Director Chris Chiames said the association will again work through its local chapters and affiliates to find community organizations that lack onsite AEDs and show financial need. As organizations are identified, donations will be made appropriate to the need, he said. Defibtech Vice President Greg Slusser added that many of the organizations chosen for donations are busy community gathering sites located far from hospitals or where average EMS response is prolonged due to drive time. Having an AED onsite is important because immediate resuscitation is vital. Studies show that more than 70 percent of victims defibrillated within a minute or two after arrest survive. If defibrillation is delayed for more than 10 minutes, only 5 percent live. In addition, to help reach the American Heart Association’s (AHA) goal of training 1 million people in CPR, many AHA National Training Centers, including Defibtech distributors Annuvia, Cintas, Code Red and LifeSavers, Inc., are offering special AED and/or AED/CPR training promotions in honor of National CPR and AED Awareness Week, Slusser said.