Industry News and Products

Medtronic Announces FDA Approval and Market Availability of Sprint Quattro Secure® S Single Coil Defibrillation Lead

Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Sprint Quattro Secure® S single coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias and sudden cardiac arrest. This new defibrillation lead is an addition to the Sprint Quattro® family that is supported by more than seven years of post-market performance data.¹ It provides an option for physicians who prefer a specific type of lead for patients with unique anatomies and is designed to help reduce tip pressure. The U.S. approval and market release of this single coil option follows its recent European approval and launch. The Medtronic Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead body (approximately 2.8 millimeters in diameter). A thin wire inserted into the chambers of the heart through blood vessels, the lead is compatible with any Medtronic implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). “I prefer a single coil lead for my patients and am looking forward to having this new option available,” said Michael Lincoln, MD, with Holy Cross Hospital in Silver Spring and NIH Heart Center at Suburban Hospital in Bethesda, Maryland. “Based on my own clinical experience and the breadth of long-term clinical performance data, I believe the Sprint Quattro family of defibrillation leads is highly reliable.” Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, said, “We are pleased the FDA has approved this single coil option, which gives physicians another choice in order to deliver the appropriate treatment to each individual patient.” In conjunction with this introduction, Medtronic is extending its defibrillation lead warranty to a lifetime limited warranty, which covers all defibrillation leads implanted in the United States on or after Dec. 1, 2008. Under the lifetime warranty, Medtronic will provide a replacement lead at no charge if the lead does not perform according to specification and meets other specified warranty criteria. It also will reimburse patients for certain unreimbursed medical expenses in the amount specified in the warranty. Defibrillation leads implanted before Dec. 1, 2008 are covered by Medtronic’s current five-year limited warranty. Medtronic has offered a lifetime limited warranty on pacing leads in the United States since 1984. ¹This prospective, multicenter clinical study, the Medtronic System Longevity Study (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. The study contains clinical data from more than 75,000 leads, of which more than 15,000 are currently active. The Sprint Quattro Secure lead family is among these active leads and has 1,367 enrollments with 51,903 cumulative months of follow-up as of July 31, 2008. _____________________________

FDA Advisory Panel Unanimously Recommends Approval of NaviStar® ThermoCool® Catheter for Atrial Fibrillation

Biosense Webster, Inc., a Johnson & Johnson company, reported the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) unanimously recommended approval of the company’s Pre-Market Approval (PMA) supplement for the NaviStar® ThermoCool® Catheter for the treatment of symptomatic paroxysmal atrial fibrillation. The NaviStar® ThermoCool® Catheter is the first ablation catheter to be recommended by the panel for FDA approval. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and one of the most common causes of stroke. “We are pleased with the recommendation for approval and will work closely with the Agency to bring this important new option to patients with AF as quickly as possible,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. Conditions for approval recommended by the review panel include a post-marketing registry and a physician education program about use of the product. Currently, there are no ablation catheters approved for marketing by the FDA for the treatment of AF in the United States. Biosense Webster requested expanding the current label for the NaviStar® ThermoCool® Catheter to include an indication for drug refractory symptomatic paroxysmal AF. The NaviStar® ThermoCool® Catheter is currently approved in the United States for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction. The unanimous recommendation was based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of AF. In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug (AAD) therapy for the treatment of symptomatic paroxysmal AF. These data were first presented at the recent American Heart Association’s Annual Scientific Sessions. Patients receiving cardiac ablation with the NaviStar® ThermoCool® Catheter, manufactured by Biosense Webster, Inc., were significantly more likely to be free of recurring AF and experienced fewer serious adverse events than those receiving AAD therapy. This clinical trial was a randomized, unblinded and controlled evaluation of symptomatic, paroxysmal AF patients who were refractory to at least one AAD and had at least three episodes of AF in the six months prior to randomization. A total of 167 patients were enrolled from 19 sites throughout the world and the primary effectiveness endpoint was freedom from documented symptomatic AF recurrence following procedural endpoint confirmation and absent new AAD use or repeat ablation outside of protocol-defined criteria. The probability of chronic success was 62.7% for patients receiving NaviStar® ThermoCool® Catheter ablation at the end of the nine-month effectiveness evaluation period, which is significantly superior (pAscent Receives Only 510(k) Clearance for Reprocessed Biosense Webster LASSO® Variable Circular Mapping Catheters Ascent Healthcare Solutions announced that it has received the industry’s first 510(k) clearance from the U.S. Food and Drug Administration (FDA) to reprocess the LASSO® 2515 Variable Circular Mapping Catheter manufactured by Biosense Webster. With this new clearance, Ascent continues to increase its portfolio of EP catheters to offer EP cath labs the ability to most effectively manage their resources while ensuring that clinicians have access to their preferred device to most effectively diagnose arrhythmias. The average price for these reprocessed circular mapping catheters is $700; a savings of 53-58 percent, compared with the national average cost of $1,500–$1,650 when these devices are purchased directly from the original manufacturer. Ascent’s focus on providing reprocessing and remanufacturing services for a wide range of high-cost, high-volume devices enables its hospital partners to reallocate its savings to staffing, services and technology that improve patient care. Hospitals using Ascent’s services also help protect the environment through reprocessing, recycling and material reclamation. According to Ascent COO Rick Ferreira, “Electrophysiology devices continue to evolve and improve, and Ascent is keeping pace by leveraging its engineering and scientific expertise to ensure that EP cath labs can maximize their resources by utilizing the industry’s most comprehensive reprocessing and remanufacturing program. Many EP cath labs rely on the savings generated through reprocessing to provide safe, high-quality care to patients with irregular heart rhythms.” The Biosense Webster LASSO¨ 2515 Variable Circular Mapping Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart and is deployed in the right or left atrium. The catheter features a variable loop that easily adjusts to any vein sized between 25 and 15 mm. Its adjustable tip provides efficient mapping and is also deflectable for maximum movement. It is available in 10 and 20-electrode configurations. These devices will be the first line of reprocessed diagnostic EP catheters to be packaged in Ascent’s thermoformed tray, which has a superior packaging design that provides even greater protection to these catheters with complex curves during transit and storage. __________________________

St. Jude Medical Announces European Approval and Initial Implant of First Device to Continuously Monitor Electrical Changes That Signal Potential Cardiac Problems

St. Jude Medical, Inc. announced European CE Mark approval of its AnalyST™ implantable cardioverter defibrillator (ICD) with ST Monitoring. The AnalyST™ ICD with ST Monitoring is a device that not only provides life-saving therapy for dangerously fast heart rhythms, but also continuously monitors electrical changes between heartbeats (ST segments) to help physicians monitor disease progression. This new monitoring capability may give physicians earlier and more accurate insight into cardiac problems and may help reduce patient risks. The device will be introduced at the International Symposium on Progress in Clinical Pacing. The AnalyST ICD with ST Monitoring is the first device to continuously monitor specific changes in the heart's electrical system that can indicate conditions such as ischemia. Changes in the ST segment also have been linked to significant clinical events such as heart attacks. Learning about these conditions earlier may lead to more timely diagnosis and therapy for patients, and possibly improve patient prognosis. With the device's monitoring diagnostic, small changes in ST segment are continuously and precisely recorded and plotted, and then retrieved for the physician to review during patient follow-up visits. Because many cardiac episodes are transient in nature, continuous ST Monitoring is important because it gives physicians more comprehensive ST segment information over time rather than a sporadic, hit-or-miss diagnostic report. In the near future, physicians also will be able to monitor patients' ST segment changes via remote transmissions from the St. Jude Medical Merlin@home transmitter, and will receive alerts through the Merlin.net patient care network. The surface ECG has been the gold standard for diagnosing risk for heart tissue damage and arrhythmias. However, surface ECG has limitations: it provides only a few seconds of information at a time, it cannot be used to continuously monitor the patient over a long period, and it is susceptible to poor signal quality. The AnalyST ICD not only provides continuous information, but it also provides high-fidelity electrograms from the inside of the heart for accurate detection of a wide range of ST segment changes. When combined with other data available to physicians, ST segment information helps physicians make better-informed, evidence-based decisions for patient care. In addition to the ST Monitoring diagnostic, the AnalyST ICD includes therapy-enhancing St. Jude Medical features, such as: • DeFT Response® technology, which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia. • SenseAbility® technology, designed to optimize sensing to help protect against inappropriate shocks. • Vibrating patient notifier, which gently vibrates, instead of issuing the standard audio alert, to notify patients if the device is not performing as designed; this can be especially beneficial for people with hearing loss. _____________________________

Spectranetics Cross-Pilot Product Receives FDA Clearance

Spectranetics Corporation announced clearance from the Food and Drug Administration for the Cross-Pilot™ Laser Support Catheter. The launch of the product will commence during the first quarter of 2009 within the United States, Europe and Canada. The Cross-Pilot is a laser support catheter for the 0.9 Turbo Elite Laser Ablation Catheter. The Cross-Pilot was designed to provide additional support for reaching distal lesions. The braid-reinforced catheter construction and hydrophilic coating allow for better pushability through distal vessels, and the angled tip allows for quicker access to branched anatomy. The Cross-Pilot Laser Support Catheter is currently offered in 125 cm length and straight and angled tip configurations. "We are pleased to receive FDA clearance for another important product," stated Emile Geisenheimer, Chairman, President and Chief Executive Officer. "The Cross-Pilot product line, and the Quick-Cross Extreme product line, which was approved by the FDA, will expand our support catheter product offering to the benefit of our physician customers and their patients." Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. _____________________________

Landmark EchoCRT Trial Enrolls First European Patients

BIOTRONIK announced European rollout of the EchoCRT trial investigating the life-saving benefits of cardiac resynchronization therapy in patients with heart failure who currently do not receive device therapy. The landmark EchoCRT trial is the largest prospective, randomized, double-blind, international, multicenter clinical trial of its kind. It is designed to demonstrate that optimal medical therapy plus CRT reduces all-cause mortality or first hospitalization for worsening heart failure in the study population compared to optimal medical therapy alone. Eligible patients must have echocardiographic evidence of left ventricular dyssynchrony (discoordinated pumping action of the heart) with a ‘narrow QRS’ width (Consuming Up To Two Drinks Per Day Not Associated With Increased Risk of Irregular Heart Beat for Women Women who have up to two alcoholic drinks per day do not appear to be at increased risk of atrial fibrillation, but drinking more than that amount is associated with a higher risk, according to a study in the December 3 issue of JAMA. Studies assessing the effects of regular alcohol consumption on the risk of atrial fibrillation have provided inconsistent results, with several studies finding significant associations between moderate to high amounts of alcohol intake and increased risks of atrial fibrillation among men, but not among women. However, these studies were not of adequate size to detect significant associations among women, according to background information in the article. David Conen, MD, MPH, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and University Hospital, Basel, Switzerland, and colleagues analyzed data from a completed randomized controlled trial involving 34,715 women participating in the Women’s Health Study, to assess the effects of regular alcohol consumption on the risk of atrial fibrillation. The participants were older than 45 years, had no atrial fibrillation at the start of the study, and underwent follow-up from 1993 to October 2006. Alcohol consumption was assessed via questionnaires at the beginning of the trial and at 48 months of follow-up, and was grouped into four categories: 0 drinks per day, greater than 0 and less than 1, 1 or more and less than 2, and 2 or more drinks per day. Atrial fibrillation was self-reported on the yearly questionnaires and subsequently confirmed by electrocardiogram and medical record review. During a median follow-up of 12.4 years, there were 653 confirmed cases of new atrial fibrillation. Among women consuming no alcohol (n = 15,370), there were 294 events (1.9 percent); for women consuming more than 0 and less than 1 drink per day (n = 15,758), there were 284 events (1.8 percent); for 1 to 2 drinks per day (n = 2,228), there were 35 events (1.6 percent); and for women consuming 2 or more drinks per day (n = 1,359), there were 40 atrial fibrillation events (2.9 percent). “In the present study, alcohol consumption of up to two drinks per day was not associated with an increased risk of incident atrial fibrillation among initially healthy, middle-aged women. In contrast, the small group of women who consumed two or more alcoholic beverages per day had a 1.6-fold greater risk for atrial fibrillation relative to nondrinking women. While this finding needs to be interpreted with some caution because of the small number of women in some subgroups, it supports a possible threshold effect in the relationship between alcohol consumption and risk of atrial fibrillation among women,” the authors write. Source: (JAMA 2008;300[21]:2489-2496.) _____________________________

Sorin Group Announces European Market Release and First Implant of New-Generation Cardiac Resynchronization Therapy Defibrillator

New PARADYM™ Provides Active Resynchronization Therapy Improving Patients’ Exercise Tolerance Sorin Group announced the commercial market release and first implant of its new-generation PARADYM™ CRT 8750 cardiac resynchronization therapy defibrillator (CRT-D). Together with the new SITUS™ BW 28D left ventricle pacing lead and lead delivery system, PARADYM CRT forms a complete new CRT system for heart failure (HF) patients. PARADYM CRT is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy in heart failure patients, thanks to the unique Brady-Tachy Overlap™ (BTO) feature. The guidelines for heart failure management recommend exercise training as part of the treatment for HF patients, as it has been shown to reduce mortality and improve quality of life. With BTO, PARADYM CRT is able to provide bi-ventricular resynchronization therapy at the elevated heart rates necessary to support patients’ exercise. However, heart failure patients often present slow ventricular tachyarrhythmias (slow VT) at the same elevated rates. Slow VTs have been reported to cause significant clinical effects. Therefore, it is important to detect and treat these arrhythmias. Unlike most other CRT-D devices, PARADYM CRT is designed to recognize and treat these slow VTs without compromise to resynchronization therapy. “The physical activity of the patient is definitely a key component to take into consideration when treating every heart failure patient. PARADYM CRT offers my heart failure patients the significant benefit of delivering resynchronization therapy during sustained exercise, while detecting and treating slower ventricular tachycardias without programming constraints,” said Dr. Christian Butter, Head of the Cardiology Department, Heart Center Brandenburg in Bernau bei Berlin, Germany, who implanted the first PARADYM CRT device in a 38-year-old woman. “In addition, I’m particularly satisfied with the small volume and thickness of this device.” For heart failure patients, it is crucial that life-saving therapies are delivered only when necessary, to avoid a decrease in the patient’s quality of life. PARADYM CRT features PARAD®+ detection algorithm, whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage reported thus far. Whenever a shock is needed, PARADYM delivers it swiftly with an energy level of up to 37J (42 J stored), the highest available in the market. This will give maximum assurance to both patients and clinicians in the treatment of life-threatening arrhythmias. _____________________________

Heart Rhythm Society Statement on Device and Lead Reliability and Safety

Statement Regarding “Learning from Our Mistakes? Testing New ICD Technology” Published by the New England Journal of Medicine The perspective “Learning from Our Mistakes? Testing New ICD Technology” by Robert Hauser, MD and Adrian Almquist, MD as well as a corresponding letter from Mitchell Shein and Daniel Schultz from the FDA were published in the December 11 issue of the New England Journal of Medicine. In response to these articles, the Heart Rhythm Society would like to reiterate its position on the importance of device and lead reliability and safety. “The Heart Rhythm Society is committed to the highest standard of patient safety,” said N.A. Mark Estes, president of the Heart Rhythm Society. “We have been at the forefront of establishing policies and guidelines to ensure the safety of life-saving devices such as internal cardiac defibrillators (ICDs) and pacemakers. The Society will continue to develop standards as technology continues to evolve.” To address issues regarding the safety of device leads, the Heart Rhythm Society created a task force earlier this year with leading experts and is currently collaborating with regulatory agencies, industry and patients to develop recommendations regarding lead performance. The Heart Rhythm Society anticipates releasing the new recommendations at Heart Rhythm 2009, the Society’s Annual Scientific Sessions, which will take place in Boston next May. “We have a proven track record of addressing device and lead reliability issues and promoting standards to improve patient care,” adds Estes. The Society’s recommendations for the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators, released in September 2006, have been adopted by physicians, government and industry, and helped to achieve greater transparency in the post-market surveillance, analysis and reporting of information; the establishment of new systems to identify malfunctioning devices more quickly; and standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified.