Industry News and Products

MADIT-CRT Trial Meets Primary Endpoint

Boston Scientific Corporation and the University of Rochester Medical Center announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29 percent reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs). High risk,1 asymptomatic or mildly symptomatic, New York Heart Association (NYHA) Class I and II2 patients were enrolled in MADIT-CRT. The MADIT-CRT Executive Committee expects to present and publish the trial's full results later this year. MADIT-CRT, sponsored exclusively by Boston Scientific, demonstrates that early intervention with cardiac resynchronization therapy can slow the progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership of Principal Investigator Arthur J. Moss, MD, Professor of Medicine at the University of Rochester Medical Center. “We are very encouraged by these initial positive results, and we are hopeful they will eventually lead to a wider population of heart failure patients being treated with CRT-D therapy,” said Fred Colen, President, Boston Scientific CRM. “I would like to congratulate Dr. Moss, the Executive Committee and all the MADIT-CRT investigators on a well designed and well executed clinical trial. Boston Scientific is proud to continue the tradition of supporting advances in indications in the CRM space through trials like MADIT-CRT. More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this therapy by a clinical trial sponsored by Boston Scientific or its predecessors.3” MADIT-CRT is providing insight into the potential of CRT-D therapy to intervene earlier in the natural progression of heart failure. Currently, patients must be in NYHA Class III/IV heart failure to be indicated for CRT-D therapy. However, approximately 70 percent of all heart failure patients in the U.S. fall into Class I or II. Nearly 22 million people worldwide, including approximately 5.5 million Americans, suffer from some form of heart failure. 1 High-risk is defined as QRS width greater than or equal to 130 milliseconds and left ventricular ejection fraction less than or equal to 30 percent. 2 The New York Heart Association clinical classifications of heart failure rank patients as Class I-II-III-IV, according to the degree of symptoms or functional limits, from asymptomatic to bed ridden. 3 Trials include MADIT, MADIT-II, CONTAK-CD and COMPANION. __________________________

St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump

Automated Irrigation Pump Provides Control Over Fluid Delivery During Radiofrequency Catheter Ablation Procedures St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump. Used in conjunction with St. Jude Medical’s open-irrigated ablation catheters, an irrigation pump supplies a continuous flow of saline through the catheter’s inner lumen to cool the ablation electrode for more effective energy delivery. Designed to enhance physicians’ ability to perform successful atrial ablations, the new Cool Point irrigation pump was developed specifically for use with the company’s IBI-1500T9-CP cardiac ablation generator and family of Therapy™ Cool Path™ irrigated catheters. “The Cool Point pump is part of a fully integrated system that has been designed for easy set up and seamless operation with our latest cardiac ablation generator and our growing family of Therapy Cool Path open-irrigated catheters,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “By introducing the Cool Point Irrigation Pump, we provide plug-and-play connectivity with the lab’s existing St. Jude Medical equipment.” In addition to the intuitive setup and operation, the Cool Point Irrigation Pump provides monitoring and safety features, which are designed to give physicians more control over therapy delivery. This interface enables physicians to monitor the total volume of irrigation solution delivered through an easy-to-read display. The pump’s proprietary tubing includes an in-line occlusion detector, which monitors flow pressure between the pump and the catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate (an indication that irrigation ports on the catheter tip may be blocked and the tip cooling may not be effective). In addition, the pump has redundant bubble detectors, each designed to detect bubbles as small as two microliters. Bubbles in the bloodstream may lead to embolism or stroke. __________________________

Clinical Registry Begins Collecting Data on Industry’s Only Pacing Systems Approved for Use in MRI Machines

Medtronic, Inc. announced first enrollments in a magnetic resonance imaging (MRI) substudy of the global PANORAMA registry, the largest and most comprehensive registry — with centers on four continents — collecting implanted cardiac rhythm device data in the world. Dr. Raed Sweidan, consultant electrophysiologist and head of the EP Department at King Fahd Armed Forces Hospital in Jeddah, Saudi Arabia, enrolled the first patient, who received a Medtronic EnRhythm MRI™ SureScan™ pacing system. “With Medtronic’s EnRhythm MRI and Advisa MRI™ SureScan™ pacing systems, which will enable thousands of patients to access MRI scans, extending the PANORAMA registry to include these systems reinforces the breadth and depth of our industry-leading, post-market quality systems,” said David Steinhaus, MD, medical director for the Cardiac Rhythm Disease Management business at Medtronic. The EnRhythm MRI and Advisa MRI SureScan pacing systems currently are not available for sale in the United States; further, no U.S. patients will be enrolled in the MRI substudy. The PANORAMA registry is collecting long-term product performance data on all types of Medtronic Cardiac Rhythm Disease Management devices implanted outside the United States, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy devices (CRTs), leads and insertable cardiac monitors (ICMs). For more than 25 years, Medtronic has published twice-annual product performance reports, the latest of which (2009 First Edition, Issue 60) includes data applicable to more than 13.8 million implanted cardiac devices and leads worldwide. The PANORAMA registry was initiated in 2005; it will involve 10,000 patients at 150 centers in 33 countries on four continents. PANORAMA parallels both the company’s System Longevity Study (SLS) and OMNI study in the United States. SLS has been capturing data for more than 25 years, and is designed to monitor the performance of commercially available implantable cardiac leads and devices; OMNI is the first large-scale longitudinal registry to follow nearly 3,000 real-world device patients. In addition to long-term device surveillance, PANORAMA is assessing adherence to and adoption of medical society practice guidelines for implanted cardiac devices. The MRI substudy will involve up to 1,500 patients at 120 centers as part of the ongoing PANORAMA initiative and will collect MRI-related epidemiological data on patients outside the United States who have received a market-approved Medtronic pacing system for use with MRI machines, the EnRhythm MRI SureScan or Advisa MRI SureScan pacing systems; the referral process for patients who require an MRI scan; and long-term data on system performance, as well as these systems’ performance when exposed to MRI scans, among others. __________________________

Owens & Minor Wins Top Honors from Premier in Three Award Categories: Supplier & Customer Service Excellence, Supplier Diversity Efforts, and Excellence in Contract Management

Owens & Minor, a leading distributor of national name-brand medical and surgical supplies and a healthcare supply-chain management company, won top honors in three award categories from Premier Inc., a national healthcare alliance. Owens & Minor was cited for its high supplier quality and customer service, for its efforts to increase the diversity of its suppliers, and for its contract management excellence. The awards were announced on June 17, 2009, at Premier's Annual Breakthroughs Conference and Exhibition in Anaheim, California. According to Premier, Owens & Minor was the only supplier to receive three individual awards. “We are honored that Premier has chosen Owens & Minor for three significant awards this year, as we place a high value on our relationship with Premier and its member healthcare providers,” said Craig R. Smith, president & chief executive officer of Owens & Minor. “We welcome Premier’s recognition of our ongoing dedication to providing superior customer service and the highest quality supply-chain management services, our successful efforts to encourage and promote diversity among our suppliers, and our expertise at managing the Premier contract.” Premier awarded Owens & Minor with the following distinctions: • Owens & Minor was one of only two organizations awarded the first annual Premier 2009 Polaris Award. The Polaris Award, which “aligns supplier contract performance with the customer service expectations” of Premier alliance members, recognizes excellence on a range of quantitative measures, as well as qualitative aspects of excellent customer service such as high relationship value and customer service, as determined by the votes of Premier members. • Owens & Minor was awarded the 2009 Premier Diversity Award for “efforts to purchase goods and services from Premier contracted diverse suppliers, as well as develop procurement strategies aligned with the communities they serve.” The award recognizes Premier-contracted suppliers that support efforts to increase purchasing from diverse suppliers and provide economic development opportunities for communities throughout the U.S. Of the more than 800 Premier suppliers eligible for this award, Owens & Minor was the only supplier chosen for this recognition. • Owens & Minor was also awarded the Premier 2009 Supplier Pinnacle Award, which is based on excellence in managing the Premier contract. Owens & Minor was one of 19 suppliers chosen to receive this award out of 800 Premier-contracted suppliers. “Premier is pleased to recognize Owens & Minor as one of our top performing suppliers with three separate awards recognizing commitment to excellence,” said Premier Purchasing Partners President Mike Alkire. “Owens & Minor works to exceed the needs and expectations of alliance member hospitals, and we commend their unsurpassed efforts to help our members better serve their communities.” __________________________

Sorin Group Announces European Market Release and First Implant of its New Generation Dual Chamber Implantable Cardioverter-Defibrillator

New PARADYM™ DR ICD Provides Extra Safety Margin for Patients with High Defibrillation Thresholds Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the commercial market release and first implant of its new generation PARADYM™ DR 8550 dual chamber implantable cardioverter-defibrillator (ICD). PARADYM DR is the second product of a brand-new platform with cutting-edge electrical performance, combining high-energy shocks, with an expected 9.5 years longevity1 in a 32.8 cc small device. PARADYM can charge up to 42 J, and delivers the highest energy shocks on the market whenever needed to treat a life-threatening arrhythmia. To avoid a decrease in the patient’s quality of life, it is crucial that life-saving therapies are delivered only when necessary. PARADYM DR features PARAD®+ detection algorithm, providing accurate therapy based on superior specificity in discriminating supraventricular tachyarrhythmias (SVT). Ventricular arrhythmias often occur as regular ventricular tachycardia (VT). In most cases these VTs can be terminated by painless anti-tachy pacing (ATP), and a painful and stressful shock can be avoided. PARADYM DR is designed to detect and treat the VTs with ATP over a range of heart rates from 100 min-1 up to 255 min-1. Dr. Peter-Paul Delnoy from the Isala Clinics in Zwolle, the Netherlands, who implanted the first PARADYM DR in a 60-year-old man, commented, “Providing therapy options to my patients is of great importance. With PARADYM, its 4 tachycardia detection zones and associated therapies, I can provide a customized treatment to each patient. I also especially value the superior SVT discrimination of PARAD+, which gives me the capability to treat slow ventricular tachycardias.” PARADYM DR also includes the SafeR™ function, which allows spontaneous atrio-ventricular conduction, while managing all three types of heart block (first, second and third degree). In this way right ventricular pacing, which has been shown to increase the risk of congestive heart failure and atrial fibrillation, can be reduced to 0.1%.2 A lot of patients receiving an ICD suffer from heart failure (HF). PARADYM DR incorporates PhD™, a new continuous monitoring function that measures the patient’s activity and breathing patterns, thus giving physicians additional insight into the patient’s clinical status. Stefano Di Lullo, President of the Sorin Group CRM business unit, commented, “Sorin Group is pleased to announce the European launch of PARADYM DR. With PARADYM DR, patients can go about their daily activities with the reassurance that arrhythmias will be accurately identified and correctly treated. PARADYM’s new PhD monitoring function is specially designed to optimize patient management.” 1 Pacing in DDD mode, 1% in atrium, 15% in ventricle, 500 ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF. 2 In 80% of non-selected patients. Anselme, et al. Heart Rhythm 2006;2(Supp 5):4-99. __________________________

FDA Approves Multaq® for Patients with Atrial Fibrillation or Atrial Flutter

Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) has approved Multaq® (dronedarone) 400 mg tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq® is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL. Multaq® is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] Heart Electrical Conduction Abnormality Believed Not to be Serious May Pose Cardiovascular Risks New research indicates that a finding on a routine electrocardiogram that signals a disorder of the electrical conducting system in one part of the heart and previously believed to be benign is associated with an increased risk for atrial fibrillation (AF), the implantation of a pacemaker or death, according to a study in JAMA. Prolongation of the electrocardiographic PR interval, also known as first-degree atrioventricular block (AVB) when the PR interval exceeds 200 milliseconds, represents delayed conduction of electrical impulses from the atria to the ventricles. It is frequently encountered in clinical practice. For patients who are not hospitalized, first-degree AVB typically occurs in the absence of cardiovascular disease. “The clinical significance of first-degree AVB in this setting is unclear. Several prior studies suggest that first-degree AVB has a benign prognosis, although these studies were based on young, healthy men in the military,” the authors write. Susan Cheng, MD, of the Framingham Heart Study, Framingham, Massachusetts, and colleagues examined the prognosis associated with first-degree AVB. The study included 7,575 individuals (average age, 47 years; 54 percent women) from the community-based Framingham Heart Study who underwent electrocardiography between 1968-1974, with follow-up through 2007. During the follow-up period, 481 participants developed AF, 124 required implantation of a pacemaker, and 1,739 died. The researchers found that individuals with first-degree AVB had an increased risk of future AF (approximately 2-fold), pacemaker implantation (approximately 3-fold) and moderately (1.4-fold) increased risk of all-cause death, compared with individuals without first-degree AVB. After adjustment for conventional risk factors, the PR interval was a significant predictor of all 3 outcomes. Each 20-millisecond increment in the PR interval was associated with an increased risk for AF, pacemaker implantation, and all-cause death. “The validity of these findings is supported by the large, community-based sample, the routine surveillance of all participants for cardiovascular outcomes, and the long period of follow-up,” the authors write. “These results suggest that the natural history of first-degree AVB is not as benign as previously believed. Additional studies are needed to determine appropriate follow-up for individuals found to have prolongation of the PR interval on a routine electrocardiogram.” Source: JAMA 2009;301:2571-2577. __________________________

Older Men With Breathing Problems During Sleep More Likely to Have Irregular Heartbeats

Increasingly severe sleep-related breathing disorders in older men appear to be associated with a greater risk of abnormal heart rhythms, according to a report in the Archives of Internal Medicine, one of the JAMA/Archives journals. In addition, different types of breathing problems appear more closely associated with different categories of arrhythmia. Sleep-disordered breathing is a common condition, according to background information in the article. It causes a number of physiologic events that could be stressful to the cardiovascular system, including inadequate blood oxygen levels at night and activation of the sympathetic nervous system (associated with the body’s fight-or-flight response). Reena Mehra, MD, MS, of Case Western Reserve University School of Medicine, Cleveland, and colleagues studied 2,911 men who underwent sleep testing by polysomnography between 2003 and 2005. The number of times they experienced apnea (brief pauses in breathing) or hypopnea (shallow breathing) during sleep was recorded, as were any periods of time in which the oxygen level of blood in their arteries dipped below 90 percent (hypoxia). Having more episodes of paused or shallow breathing was associated with increased odds of two types of arrhythmias — one involving the heart’s upper chambers and one involving the heart’s lower chambers. Obstructive sleep apnea — the most common type, involving a partial or complete blockage of the airways — was associated with irregular heartbeats caused by a problem with the ventricles. Lower blood oxygen levels also appeared to be associated with this type of arrhythmia. However, central sleep apnea, involving a malfunction in brain signals controlling breathing muscles, was more strongly associated with arrhythmias in the atria. More severe cases of sleep-disordered breathing were associated with higher odds of arrhythmia; in addition, “there also seems to be a threshold effect such that moderate-to-severe sleep-disordered breathing confers the greatest increased odds of clinically significant arrhythmias independent of self-reported heart failure and cardiovascular disease,” the authors write. “This line of investigation also identified hypoxia as the possible culprit pathophysiologic characteristic of sleep-disordered breathing that may serve as the trigger of ventricular cardiac arrhythmia development in older men. The strong associations between central sleep apnea and atrial fibrillation suggest that central sleep apnea may be a sensitive marker of underlying abnormalities in autonomic or cardiac dysfunction associated with atrial fibrillation,” they conclude. “Further prospective and intervention studies are needed to better determine causality and the impact of aggressive sleep-disordered breathing interventions on cardiac outcomes.” Source: Arch Intern Med 2009;169:1147-1155. __________________________

CardioFocus Receives CE Mark for Atrial Fibrillation Ablation Catheter

CardioFocus, Inc. announced that it has received a CE Mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation. The EAS is the latest generation, percutaneous catheter system that has been used clinically to treat patients with atrial fibrillation. This novel device incorporates both a micro-endoscope and light energy fibers to give physicians the capacity to actually see within the heart, and for the first time, visually direct the application of energy through a catheter. “We are grateful for the thorough review and the rapid response we received from our notified body,” said Burke Barrett, CardioFocus VP of Clinical and Regulatory Affairs. Atrial Fibrillation is a common cardiac arrhythmia affecting several million people in Europe and over 2.5 million more in the United States. Researchers believe that the considerable incidence and prevalence of the disease are increasing due to aging populations worldwide. Professional medical societies have endorsed the use of catheter ablation therapy when anti-arrhythmic drugs are ineffective, which can occur more than half the time. “The EAS represents a new era for catheter ablation of this complex arrhythmia. The CardioFocus device provides the electrophysiologist with a direct view of the cardiac anatomy that simply has not been available using other catheters. I believe that seeing the true orientation of the anatomy in full color and in real time, combined with the ability to safely and reliably deliver energy to the right target, increases the likelihood of delivering effective therapy,” said Vivek Y. Reddy, MD, Director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York City. The EAS was the subject of several presentations at the recent Heart Rhythm Society meeting in Boston, highlighting excellent clinical results, simplified ease of use, reduced x-ray exposure and shortened procedure times. The CardioFocus device was also featured on the scientific program at the EuroPace meeting in Berlin in June, and will be prominent on the program at the Europe AF meeting in London in September. Since clinical results were reported at the 2009 Boston AF Symposium, physician interest in visually guided catheter ablation has been accelerating dramatically. As reported by several top centers, current catheter therapies are effective in barely 50% of patients receiving a single treatment. “CE Marking for our product highlights the great progress our company has made; our entire group has been dedicated to achieving this milestone. This facilitates more ambitious international research and European commercialization of our device. Cardiac electrophysiology is a focused area of medicine where a small company can make a big impact with the right product. Our interactions with well known specialists worldwide have provided enormous encouragement,” commented Stephen W. Sagon, CardioFocus President and CEO. __________________________

Vascular Solutions Launches the Trespass™ Angiographic Catheter

Vascular Solutions, Inc. announces the availability of the new Trespass™ angiographic catheter. The Trespass catheter is specifically designed for use by interventional radiologists and other physicians performing endovascular abdominal aortic aneurysm (AAA) repair procedures, and its unique hybrid design offers simplicity and multiple functionality. The Trespass angiographic catheter combines an angled tip design to facilitate guidewire delivery and direction with radiopaque markers for vessel sizing and sideports for high-pressure injections. Because the Trespass is a flush catheter, angled tip catheter and vessel-sizing catheter all in one, it replaces multiple catheters that are commonly used in AAA procedures with just one. The catheter comes in a 5 French, 65 cm configuration. The Trespass catheter is intended for use for delivering radiopaque media to selected sites of the vascular system, and for pressure and anatomical measurements, and is currently available for sale in the United States. Vascular Solutions, Inc. is a leading medical device company that delivers proprietary clinical solutions for diagnosing and treating vascular conditions. The company’s rapidly growing product line consists of innovative devices across established and emerging areas of coronary and peripheral vascular medicine. Trespass is a trademark of Vascular Solutions, Inc.