Genaissance Pharmaceuticals Launches its Proprietary FAMILION™ Test for Genetic Mutations Associated with Sudden Cardiac Death
       Genaissance Pharmaceuticals, Inc. announced the launch of its proprietary FAMILION™ Test — a genetic test for cardiac channelopathies — at Heart Rhythm 2004, the Heart Rhythm Society’s 25th Annual Scientific Sessions. Cardiac channelopathies is a broad clinical category that includes Long QT (LQTS) and Brugada Syndromes, two causes of arrhythmia that can result in sudden cardiac death. The FAMILION™ Test: 1) Confirms the presence of mutations known to cause cardiac channelopathies; 2) Identifies family members who have similar mutations; and 3) Assists physicians in choosing the most appropriate course of treatment for each patient.
       “The availability of this test will be of tremendous benefit to families and individuals who are or may be affected by one of these inherited causes of cardiac arrhythmias,” said G. Michael Vincent, MD, Professor of Medicine, University of Utah and Chairman of the Department of Medicine at LDS Hospital, Salt Lake City. “The diagnosis by an electrocardiogram is often difficult and may be overlooked, leaving patients at risk for tragic events. This test will help clarify the diagnosis in those persons and allow early and proper treatment and follow up.” Dr. Vincent, a cardiologist and a founder of the SADS (Sudden Arrhythmia Death Syndromes) Foundation, has spent much of his career investigating and caring for patients with these disorders.
       “This launch marks a major milestone for Genaissance for three reasons,” said Kevin Rakin, President and Chief Executive Officer of Genaissance Pharmaceuticals, Inc. “First, it demonstrates that we are building a portfolio of proprietary pharmacogenomic products, enabling us to move steadily up the value curve. Second, we view this as further evidence of the steadily increasing shift towards personalized medicine that is now underway, reinforced by the positive regulatory environment for such products. Third, it positions Genaissance to collaborate with pharmaceutical companies to avoid costly drug-induced long QT problems by applying the FAMILION™ Test and our HAP™ discovery engine in clinical trials.” 
       Patients with symptoms of cardiac channelopathies are typically referred to pediatric cardiologists and electrophysiologists, whom Genaissance will initially target for the FAMILION™ Test. The diagnosis of a cardiac channelopathy by an electrocardiogram (ECG) is often difficult and may be missed, which leaves a patient at risk of a sudden cardiac death. The FAMILION™ Test will confirm the presence or absence of genetic mutations in five cardiac ion channel genes. Which gene is affected is important, both for clarifying the risk of death and for guiding the treatment of patients and their family members. For example, patients with a mutation in the LQT1 gene have the highest risk of having a cardiac event by the age of 40, and patients with a mutation in LQT3 have the lowest. Researchers have also demonstrated that patients with mutations in the LQT1 and LQT2 genes have better outcomes when treated with beta-blocker therapy, while patients with mutations in the LQT3 gene may be better managed with an implantable defibrillator. 
       Physicians will draw a blood sample that will be sent to Genaissance’s CLIA-licensed facility in New Haven, Connecticut. Genaissance will extract DNA and sequence five cardiac ion channel genes. Based upon the test results, physicians may recommend to immediate family members that Genaissance also analyze their DNA with the FAMILION™ Test for the presence or absence of the specific mutation(s) found in the original patient.
       Long QT and Brugada Syndromes, two types of cardiac channelopathies, are disorders that are typically discovered in the first four decades of life and can be fatal if not diagnosed and treated appropriately.
LQTS is a condition that impairs the electrical system of the heart. Symptoms of LQTS may include fainting, seizures, abnormal and fast heartbeats and even death. For some people, these symptoms only occur when they are stressed or taking certain medications. Most of the deaths can be prevented with early diagnosis and treatment of LQTS. People with LQTS have hearts that look and sound normal but may have abnormal electrical activity when examined with an ECG. Some people with LQTS have a normal ECG at rest but experience abnormal responses under certain conditions. For example, these people may have an unusual response when they are startled, experience emotional stress or engage in vigorous physical activities. LQTS can be an inherited or an acquired disorder.
       Brugada Syndrome is very similar to Long QT Syndrome, however, the characteristic ECG finding is different. Syncope is the most common symptom. Ventricular fibrillation, a rapid, irregular heartbeat affecting the ventricles, can also occur. During ventricular fibrillation, blood flow to the body is reduced. If not corrected, ventricular fibrillation can cause death. 
       Genaissance Pharmaceuticals, Inc. is a leader in the discovery and use of human gene variation for the development of a new generation of DNA-based diagnostic and therapeutic products. Genaissance markets its technology, clinical development skills and pharmacogenomic services as a complete solution for improving the development, marketing and prescribing of drugs. Genaissance offers the FAMILION™ Test, a CLIA-compliant genetic test for cardiac channelopathies.

Transurgical, Inc. Changes Name to ProRhythm, Inc.: New Name Reflects Focus on Treatment of Atrial Fibrillation
       Transurgical, Inc, (TSI) announced that it will change its name to ProRhythm, Inc. The change is effective immediately. Since 1997, Transurgical has pioneered the application of High Intensity Focused Ultrasound (HIFU) to advance the non-invasive treatment of complex medical conditions.
       In recent years, the company has concentrated its efforts on the development of HIFU for the treatment of a debilitating arrhythmia, atrial fibrillation (AF).
       AF is an uncontrollable, rapid heartbeat that results in a significant decline in the quality of life and can lead to serious complications, including stroke. Globally, approximately eight million people are afflicted with AF, and the current treatment options are often inadequate. Transurgical’s recent advancements in the use of HIFU technology for the treatment of this disease allow the patient to be treated through a minimally invasive, non-surgical procedure.
       “Changing the name of our company is intended to more clearly identify and communicate our core business and our mission — to develop products that can return patients with atrial fibrillation to sinus rhythm,” said Reinhard Warnking, President and CEO of Transurgical, Inc. “Changing the name of our company also allows us to more accurately identify with our customer base, the cardiac electrophysiologist.”
       Transurgical’s HIFU technology is currently being used in clinical trials in Europe and the United States to treat patients with AF. The company believes that its technology can play a significant role in the treatment of this disease and help to improve the lives of individuals who are afflicted by AF.

Angiotensin II Inhibitor Suppresses Lone Atrial Fibrillation
       Recurrences of atrial fibrillation in patients without hypertension or structural heart disease can be delayed or prevented by treatment with amiodarone plus the angiotensin II inhibitor irbesartan, according to a small randomized study presented at the Heart Rhythm Society 25th Annual Scientific Sessions.
       The study's 79 patients with so-called “lone” atrial fibrillation were randomized to one of three treatment groups, amiodarone alone or combined with one of two irbesartan dosages, before electrical cardioversion. The hazard ratio for recurrence in the group that received the higher irbesartan dosage of 300 mg/day was 0.17 (95% CI 0.05–0.62; p = 0.0075) over a median follow-up of 210 days, reported Dr. Irene M. Marin from the Hospital Ramon y Cajal in Madrid, Spain.
       The likely mechanisms behind the benefit are inhibition of arrhythmia-induced atrial remodeling as well as reduction of arterial pressures, Marin said. In retrospect, there appeared to be a direct relationship between higher initial blood-pressure levels and likelihood of atrial-fibrillation suppression by irbesartan, he said.
       Angiotensin II inhibition has been associated with fewer atrial-fibrillation recurrences in patients with cardiomyopathies or other structural heart disease, but the data are thinner in patients with the lone arrhythmia.

Medtronic Announces European Release of Innovative InSync Sentry Cardiac Resynchronization Therapy Defibrillator
       Medtronic, Inc. announced the European market release of the InSync Sentry™ cardiac resynchronization therapy defibrillator (CRT-D), signaling a new era in heart failure management with the convergence of clinically proven therapy, sophisticated diagnostics and advance warning capabilities in a single implantable device.
       The InSync Sentry is a CRT-D device with automatic fluid status monitoring, which can be programmed to alert patients and clinicians to changes in fluid accumulation in the lungs and thoracic cavity. When used with other standard clinical assessments, this indicator offers the potential for early warning of fluid accumulation and appropriate clinical response.
       Heart failure is the number one cause of hospital admissions, and most of these admissions are due to fluid accumulation in the lungs, which is extremely challenging to manage and often goes undetected until the patient is critically ill. It is not unusual for these patients to require hospitalization or urgent treatment at an emergency room or critical care unit for severe respiratory distress. With hundreds of thousands of hospitalizations each year, this care pathway is a tremendous cost burden to the world's healthcare systems.
       “An implantable device that can automatically monitor a patient's fluid status and potentially provide an early warning of worsening symptoms is an incredibly significant advance in medical technology,” said Professor Cheuk-Man Yu, MD, Prince of Wales Hospital in Hong Kong and the principal investigator evaluating the feasibility of using an implantable device to track patient fluid levels.
       An exclusive new feature called OptiVol™ Fluid Status Monitoring measures changes in intra-thoracic impedance, which is an indication of a patient's changing fluid volume. Physicians set a threshold for each patient, and when the threshold is crossed, the patient and clinician are alerted, providing for the possibility of earlier clinical assessment.
       A key challenge is that normal fluid levels may vary from patient to patient, and fluid accumulation can be either chronic and slow, or acute and rapid. OptiVol is unique in that it takes measurements over time to develop a trend. By monitoring vital physiologic functions on top of standard clinical practice, OptiVol provides clinicians with an additional source of information and important new insights into patient management.
       “One of the major consequences of advanced heart failure is a significant worsening of symptoms that decrease the patient's quality of life,” said Steve Mahle, President of Medtronic Cardiac Rhythm Management. “Many of these symptoms are due to fluid accumulation, and with InSync Sentry, physicians and patients can now monitor this condition more closely and get information earlier. This is a major benefit for patients and excellent news for the healthcare system.”
       InSync Sentry offers a small size (40 cc) with increased longevity and the ability to terminate most fast ventricular tachyarrhythmias painlessly without shocks. Clinical studies have shown that Medtronic's anti-tachycardia pacing (ATP) function can dramatically reduce the need for shocks to treat fast ventricular arrhythmias — a significant patient benefit — by as much as 77 percent.
       InSync Sentry offers 35 joules of delivered energy, which is important because studies have indicated that heart failure patients sometimes require more energy to terminate life-threatening arrhythmias, and their defibrillation thresholds may rise over time. Patients with heart failure also are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population. In addition, the device maintains CRT during changing patient conditions such as atrial fibrillation, a common co-morbidity that affects about one-third of all heart failure patients.
       Approximately 22 million people worldwide have heart failure, including more than three million in France, Germany, Italy, Spain and the United Kingdom. Of these three million patients, approximately 450,000 have moderate to severe heart failure with ventricular dyssynchrony and are candidates for CRT.
       Heart failure, the only major cardiac condition that continues to grow in prevalence, is reaching epidemic proportions in Europe and is an increasing burden on healthcare systems. In Germany alone, it is estimated to cost nearly six billion Euros to manage chronic heart failure, with more than 55 percent of this figure associated with hospitalizations.

Biophan Announces Details of Study on Pacemaker Safety: Study Indicates Efficacy of Company’s Biomedical Technologies
       Biophan Technologies, Inc. announced details of a recent study on pacemaker safety. The details, released at the 2004 Heart Rhythm Society annual meeting in San Francisco, are available at: http://www.biophan.com/pacinglead.php.
       The study indicated that a standard pacemaker lead, attached to a pacemaker, will heat up at temperatures varying from as low as 2.2 degrees Centigrade to as high as 29.2 degrees Centigrade in a standard (1.5 Tesla) MRI machine. The higher temperatures are well in excess of the FDA recommended maximum temperature limit of 2.0 degrees Centigrade.
       Additionally, examination of the pacemaker electronics revealed that the exposure to the MRI procedure introduced several anomalies into the operation of the pacemaker, which could also interfere with proper pacemaker performance.
       “There has been some misunderstanding and debate about the potential for heating and other dangers associated with pacemaker exposure to MRI. Various researchers have reported different findings,” stated Michael Weiner, CEO of Biophan. “This study demonstrates that there are many variables that can affect the performance of a pacemaker during an MRI procedure, such as the position of the device in the patient and the position of the patient in the MRI machine. We have demonstrated that the heating occurs not within the pacing lead, but at the electrode-heart interface where it has the potential to significantly damage heart tissue which can then interfere with the safe operation of the pacemaker.”
       The study also evaluated several of Biophan's solutions to the heating problem, including an RF filter, which consistently reduced the heating to within acceptable FDA guidelines under all MRI test conditions. The study was performed by Biophan’s research team and electrophysiologists from a leading western New York university. Additional studies of other pacemaker safety problems are planned.
       Biophan is in discussions with several pacemaker manufacturers concerning adaptation of its technology in future pacemaker and defibrillator products. The study was performed to collect the information that will be needed by the manufacturers when they seek approval from the FDA to market an MRI-safe pacemaker.

CryoCath Completes Enrollment in First Stage of Atrial Fibrillation Study:
Early Data Shows Promising 95% Acute Success Rate Using “Tool Box” Treatment Approach
       CryoCath Technologies Inc. announced that it has completed enrollment in the first stage of its two-part Investigation Device Exemption (IDE) study for the treatment of atrial fibrillation (AF). The study involves a unique “tool box” approach to treat AF using up to three different CryoCath catheters: Arctic Circler™, Freezor® Xtra and Freezor® MAX.
       The first stage of the study, designed to establish the safety and viability of the “tool box” approach, enrolled 24 patients and was conducted at Massachusetts General Hospital under Dr. Vivek Reddy in Boston, at St. Joseph's Hospital by Dr. Jim Irwin in Tampa, Florida, and at Memorial Hospital in Colorado Springs, Colorado by Dr. Chris Cole. Dr. Reddy is acting as the principal investigator for the trial.
       Initial results showed a 95% acute success rate in achieving electrical isolation in all treated veins. As per the trial protocol, there was also a 95% success rate in establishing a flutter ablation line (confirmed by bi-directional block) in the right atrial isthmus to proactively prevent atrial flutter, which often triggers AF events. There were no reports of serious adverse events.
       “The early results from this trial, demonstrating the safety and feasibility of this approach, suggest a potentially exciting advancement in the field of AF ablation,” said Dr. Chris Cole. “We eagerly anticipate the initiation of the next stage of this trial.”
       “These results, in conjunction with our recently announced Arctic Circler Balloon data, indicate the strength of the ‘tool box’ strategy and its utility in the safe and effective treatment of AF,” said Steven G. Arless, President and CEO of CryoCath. “Our catheter-based solutions, in conjunction with our commercialized surgical system, which continues to gain market share, position us as a leader in the fight against this widespread cardiac disease.”
       Subsequent to receipt of final three-month chronic safety (stenosis) results and six-month safety and efficacy data, expected in September and December respectively, the company intends to initiate the second stage of the study. The pivotal study, scheduled to begin in the first quarter of calendar 2005, will generate sufficient data to support submission of a Pre-Marketing Approval (PMA) application to the US Food and Drug Administration (FDA). The final protocol for the second stage of the study is currently in development, but based on the encouraging preliminary data derived from the Arctic Circler Balloon human feasibility study, the company intends to incorporate this proprietary catheter in the final stage of the “tool box” clinical trial.
       Arctic Circler Linear and Arctic Circler Balloon, both uniquely configured to treat AF originating in the PV, have the ability to create lesions rapidly within the ostia (openings) of the four PVs. Freezor Xtra can be used to touch up gaps, resulting from unique PV anatomy, if necessary. Freezor MAX will be used to create a flutter ablation line in all AF patients whether atrial flutter is present or not.
       With a priority focus on providing physicians with a complete solution of catheter and surgical products to treat cardiac arrhythmias, CryoCath has multiple products approved in the U.S. and across Europe. The company is developing additional products to expand its pipeline of products to treat cardiac arrhythmias and has development projects for the treatment of cardiac ischemia and peripheral arterial disease.

Medtronic Announces European Release of Intrinsic Implantable Cardioverter-Defibrillator: ICD has Ability to Minimize Ventricular Pacing Using New MVP Pacing Mode
       Medtronic, Inc. announced the European market release of the high-energy Intrinsic™ implantable cardioverter-defibrillator, an ICD with Managed Ventricular Pacing™ (MVP). MVP is a new pacing mode designed to promote natural heart activity by minimizing unnecessary right ventricular pacing, which is accomplished by automatically switching between single- and dual-chamber pacing based on specific patient needs. Medtronic received CE Mark for this device on May 4, 2004.
       Recent clinical studies have shown that excessive ventricular pacing may be harmful to some patients, possibly leading to heart failure. The Intrinsic ICD was specifically developed for patients who are at risk for sudden cardiac arrest and need the protection of an ICD, but whose electrical conduction may be normal and require little or no pacing.
       Using beat-to-beat verification of a patient's natural electrical conduction system, the MVP mode allows the device to provide dual-chamber pacing of the right ventricle when needed, but it automatically switches to atrial pacing as its primary therapy when normal heart conduction is present. Most physicians prefer dual-chamber devices for their patients because of the advantages in maintaining a more normal heart function and improved detection between heart rhythms that may be dangerous and those that likely are not. Dual-chamber devices also collect important diagnostic information. However, the MVP mode helps ensure that patients are not over-paced when it's unnecessary.
       “Because of the MVP mode capability, the Intrinsic ICD meets an important clinical need for physicians, and I expect it to be of significant benefit for my patients,” said Dr. Francis Murgatroyd, King's College Hospital, London, UK. “By minimizing right ventricular stimulation but still retaining the safety of dual-chamber pacing as a backup, this device offers implanting physicians the best of both worlds.”
       With the MVP mode, automatic switching between dual-chamber pacing and single-chamber atrial pacing (AAI pacing) can reduce the amount of ventricular pacing to less than 5 percent, compared to 50 percent or more with typical dual-chamber pacing. For patients with less frequent pacing needs, this clinical difference can be dramatic over the lifetime of the device.
       “This product is a great example of how our research and development team was able to come up with a solution to a significant clinical problem,” said Steve Mahle, President, Medtronic Cardiac Rhythm Management. “There is nothing more important than developing a technology that combines safety features with important patient benefits. This is what we've accomplished with the Intrinsic ICD.”
       The device offers 35 joules of energy, a small 38 cc size and a typical longevity of up to eight years, making it very cost-effective for the healthcare system.
       In addition, the device also has the ability to painlessly terminate most fast ventricular tachyarrhythmias by using short pacing bursts instead of shocks. Clinical studies have shown that Medtronic's sophisticated detection algorithms and anti-tachycardia pacing (ATP) function can dramatically reduce shocks for treating ventricular arrhythmias by as much as 77 percent, a significant patient quality of life benefit.
       The Intrinsic ICD is part of the Medtronic Physiologic Pacing Program, a comprehensive initiative focused on providing tailored medical technology solutions to help replicate a patient's normal cardiac function.