Industry News and Products

Bristol-Myers Squibb Enters Global Collaboration with Nissan Chemical and Teijin Pharma on Novel Atrial Fibrillation Compound

NTC-801 is a Selective Acetylcholine-Activated Potassium Channel Blocker Bristol-Myers Squibb Company announced a global collaboration with Nissan Chemical Industries, Ltd. and Teijin Pharma Limited for the development and commercialization of NTC-801, a selective inhibitor of the acetylcholine-activated potassium ion channel (IKACh), currently in Phase I development in Japan, for the maintenance of normal sinus rhythm in patients with atrial fibrillation. Under the terms of the collaboration agreement, Nissan Chemical and Teijin Pharma will grant to Bristol-Myers Squibb exclusive rights for the development and commercialization of NTC-801, and certain backup compounds, worldwide, excluding Japan. An upfront cash payment of $40 million, potential development-based milestone payments of up to $170 million, sales based milestones of up to $175 million and royalties on net sales for licensed products are payable by Bristol-Myers Squibb. Nissan Chemical has previously granted Teijin Pharma exclusive rights to NTC-801 in Japan. “There is significant unmet medical need for a more effective and safer therapy for atrial fibrillation,” said Francis Cuss, MD, senior vice president, Discovery and Exploratory Clinical Research, Bristol-Myers Squibb. “We are pleased to have the opportunity to work with Nissan Chemical and Teijin Pharma to develop this atrial-selective antiarrhythmic medicine. NTC-801 provides us with the opportunity to leverage our company’s deep expertise in helping patients prevail over cardiovascular disease, and further strengthens and expands our pipeline in cardiovascular adjacencies.” NTC-801 is an oral inhibitor of the acetylcholine-activated potassium IKACh channel in Phase I development in Japan for the treatment of atrial fibrillation/flutter. Because IKACh channel activity is apparent in the atria, but not in the ventricles, NTC-801 could provide a more targeted and safer therapy for atrial fibrillation. ____________________________

TZ Medical Inc. Announces the Addition of Natural Anti-Microbial Barrier Claim to Its Neptune Products

TZ Medical, Inc. announced the additional claim of “Natural Anti-Microbial Barrier” to its Neptune family of topical hemostatic devices, which include the Neptune pad, Neptune Disc, and Neptune Comfort Band. The claim of “Natural Anti-Microbial Barrier” is related to the natural characteristics of calcium alginate. Calcium alginate is the main component of the Neptune family of hemostatic products. “Having a natural anti-microbial barrier is an effective deterrent to hospital-acquired infections and should help our customers reduce their costs,” according to Thomas R. Tribou, President of TZ Medical, Inc. Additionally Mr. Tribou went on to say “Millions of Neptune products have been used safely on patients around the world without any concern of adverse antibody reactions. Hospitals and patients will now have additional benefits from using the all natural Neptune products.” The Neptune families of hemostasis devices are made from calcium alginate, which is derived from seaweed. It is a natural product and does not incorporate any blood product derivatives, human or animal, which have been known to cause harmful antibody reactions in patients who have been exposed to them. Neptune works by accelerating the patient’s own clotting process by providing: • Additional calcium ions to speed topical clot formation; • Hydrophilic absorption of excess blood as it speeds the clotting process; • A textured matrix to facilitate clot formation. TZ Medical, Inc. is a privately owned company, founded in 1992 and headquartered in Portland, Oregon. The company has focused on innovation and the development of crucial products for the cardiac, electrophysiology and critical-care medical markets. TZ Medical, Inc. currently markets the following products worldwide: Neptune, natural wound dressings that facilitate clotting; the Booker System, an electrophysiology switch box; LifeLinks, a complete line of multifunction electrodes; Imaginations, a unique product line of single-use, multiple-pole electrophysiology catheters; and Tele-Rhythms, a line of pacemaker monitors and event recorders. ____________________________

Hansen Medical Announces Strategic Relationship with Advanced Cardiac Therapeutics and Procurement of Certain Exclusive Rights to its Patented Microwave Radiometry Technology

Hansen Medical, Inc. announced an equity investment in Advanced Cardiac Therapeutics, Inc. (ACT), and the securing of exclusive rights to certain ACT intellectual property for certain robotic applications. ACT, a privately held company located in Laguna Beach, California, is developing a novel technology that is designed to accurately measure the temperature in a lesion during cardiac ablation procedures. Current manual technology used by physicians to control catheters in electrophysiology procedures can be limiting in several ways, including precise catheter control and stability as well as the inability to accurately sense tissue temperature and its potential effect on lesion quality. The Sensei® Robotic Catheter System from Hansen Medical has helped to advance the control of electrophysiologic mapping catheters by using flexible medical robotics technology to provide stable and predictable control of catheter movement inside the heart. ACT’s patented Microwave Radiometry System has the potential to be incorporated into standard and irrigated cardiac catheters. A catheter with ACT’s technology would have the potential to assist electrophysiologists by providing real-time feedback about effective energy delivery by the catheter. ACT’s technology has not been clinically tested and has not received regulatory approval. In reference to the technology, Paul Wang, MD, a leading electrophysiologist at Stanford University Medical Center, says he believes that “Accomplishing accurate and real-time temperature sensing has the potential to dramatically improve our ability to create safe, efficacious and persistent lesions.” “Hansen Medical continues to build on the value of flexible robotics technology and we are very pleased to add certain rights to this promising Microwave Radiometry System to our technology portfolio,” said Frederic Moll, MD, founder and chief executive officer, Hansen Medical. ____________________________

First U.S. Patient Receives Transoma Medical’s Sleuth AT™ Implantable Cardiac Monitoring System

System Offers Advanced Trending for Long-Term Monitoring of Complex Arrhythmias; Ohio State University Medical Center Site of First Implant Transoma Medical, Inc., manufacturer of Sleuth and Sleuth AT, the first wireless, automated implantable cardiac monitoring systems, announced that the first U.S. patient has received the company’s new Sleuth AT™ (Advanced Trending) Implantable Cardiac Monitoring System. The implant was performed on March 2 by Dr. Troy Rhodes, an electrophysiology fellow under the supervision of Dr. Mahmoud Houmsse at the Ohio State University Medical Center in Columbus. The company received FDA 510(k) marketing clearance for its next-generation product on February 11, 2009. A U.S. launch is under way to introduce Sleuth AT to physicians who manage patients with complex arrhythmias as well as patients who experience infrequent, unexplained symptoms such as fainting or palpitations. “The implant went very well and took only about 15 minutes,” reported Dr. Houmsse. “This new system also offers the option of a longer 8 cm antenna, which showed very impressive, high-quality ECG signals even before the incision was closed.” Sleuth AT allows physicians to program the capture of high-quality ECG strips at frequent intervals, providing a new level of insight into complex arrhythmias that are often asymptomatic and frequently changing. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by Certified Cardiac Technicians, who classify and notify physicians of the presence of a wide variety of cardiac arrhythmias such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation (AF). “Transoma’s enhanced Sleuth system is an exciting new development for physicians who manage difficult and changing complex arrhythmias such as atrial fibrillation,” said Dr. John Hummel, also from the Ohio State University Medical Center. “Although some therapies appear to be curative, one needs to be certain that the benefits are lasting. With Sleuth AT, I can sample 20-second ECG strips as often as every 7.5 minutes and be alerted through the monitoring center of recurrence of these arrhythmias. The Sleuth AT will provide baseline cardiac information prior to a planned AF ablation procedure and will help me monitor for recurrence of AF after the procedure. Regardless of the outcome, the access to long-term monitoring will allow me to manage the patient’s need for medications, including anticoagulation therapy.” AF is the most common cardiac arrhythmia, affecting approximately 2.2 million patients in the United States, and is increasing in prevalence as the population ages. Presence of AF can lead to two to seven times higher risk of stroke, an increased risk of heart failure or sudden cardiac death, due to inefficient pumping of the heart. “We are very excited that the first implantations of our Sleuth AT System are underway,” said Nestor Jaramillo, Transoma Medical vice president of sales and marketing. “We are having great success with our first-generation Sleuth system, and many physicians are using the device to aid their diagnosis of conditions behind recurring unexplained syncope and palpitations. With Sleuth AT, physicians can use the new capabilities in their management of an even wider spectrum of cardiac abnormalities.” ____________________________

Black and Hispanic Patients Less Likely to Receive Treatment for Advanced Heart Failure

New research reveals that black and Hispanic patients who were eligible for cardiac resynchronization therapy with defibrillator (CRT-D) were less likely to receive therapy than eligible white patients. The study also found that both minority groups were more likely to meet established criteria and white patients were more likely to receive CRT-D outside of published guidelines. The new study, published in the March edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, is the first of its kind to examine and compare Hispanic, white and black patients within a national study population. The national study examined 108,341 participants in more than 1,000 hospitals enrolled in the National Cardiovascular Data Registry (NCDR) from January 2005 through April 2007. The NCDR ICD Registry™, developed in collaboration with the American College of Cardiology and the Heart Rhythm Society, was examined for racial and ethnic disparities in CRT-D implantation. Steven A. Farmer, MD, Cardiovascular Division at the Hospital of the University of Pennsylvania in Philadelphia, reviewed the number of patients who received an ICD or CRT-D and among them, the number of patients who met established guidelines. Of the 108,341 registry participants: • 22,205 patients met guidelines to receive an ICD or CRT-D; • 27,165 patients received CRT-D therapy, more than the actual number of people who were eligible. Analysis of the registry data reveals racial disparities within the study population. Results conclude that CRT-eligible black and Hispanic patients were less likely to receive CRT-D than were white patients. A substantial proportion of patients received CRT-D outside of published guidelines, although black and Hispanic patients were more likely to meet all eligibility criteria. “These results reinforce a number of questions about how race and ethnicity can impact who receives advanced treatment for heart failure,” stated lead author Dr. Farmer. “It is very surprising that there are a significant number of ICD patients who meet the required criteria for CRT-D and are not receiving the therapy, while many patients who receive the treatment fail to meet those same guidelines.” The results reflect unexplained ethnic differences in treatment for patients with advanced heart failure. The research findings suggest an important opportunity to improve care by expanding access to CRT-D therapy for eligible minority patients. ____________________________

Fighting Sudden Cardiac Arrest By Enabling Good Samaritans

Boston Life Save Highlights Value of Automated External Defibrillators and Laws that Protect their Users Three Good Samaritan rescuers in Boston recently used a Defibtech automated external defibrillator (AED) to save the life of a man who collapsed from sudden cardiac arrest at a North Station rail platform. There have been many similar life saves across the country. These actions highlight the value of Good Samaritan laws, which protect rescuers from unfair lawsuits. These laws, on the books in all 50 states, have spurred the creation of public-access AED programs throughout America. “Thousands of lives have been saved by automated external defibrillators because individuals have been able to trust their natural impulse to respond to a sudden cardiac arrest victim rather than being afraid of getting sued,” said Dr. Glenn W. Laub, Defibtech CEO and Chairman of Cardiac Surgery and Director of the Heart Hospital at St. Francis Medical Center in Trenton, New Jersey. The Boston Good Samaritans needed to react with a readily available AED in just a few minutes; sudden cardiac arrest victims treated with an AED within five minutes usually live while those left unattended for 10 minutes usually die, Dr. Laub explained. “Expecting EMS to arrive within 10 minutes, especially in Boston traffic, places unrealistic expectations on these professional responders,” Dr. Laub wrote in a commentary on the importance of enabling life saves with defibrillators. Despite the thousands of lives saved by public access defibrillator programs, some organizations are still nervous about committing to a program’s oversight, training and maintenance requirements, fearing the liability consequences if an error is made. For example, a recent Wall Street Journal article, “Why Hotels Resist Defibrillators,” (Feb. 24, 2009) outlined the reservations of some hotel chains. “Yes, deploying and maintaining AEDs and training employees on how to use them requires responsibility and a degree of risk. But have hotels considered the risks of not having AEDs?” Dr. Laub wrote, in a response to the Wall Street Journal article. The Sudden Cardiac Arrest Association also questioned the hotel industry’s approach to on-site AEDs. “Thousands of employers large and small have implemented programs to protect their employees and provide rapid response to workers who might suffer sudden cardiac arrest on the job. If nothing else, hotel executives who resist AEDs should think about the employee health and welfare benefits that go along with an emergency plan that involves staff CPR training and access to an AED,” said Chris Chiames, executive director of the Sudden Cardiac Arrest Association. To help organizations overcome liability risks — and thereby enabling Good Samaritans — Defibtech introduced a value-added service, Defibtech MD, which helps organizations to operate AED programs that meet oversight, training and maintenance requirements. “Just like a fire extinguisher or any other safety device, an AED must be properly maintained after it is purchased and placed into service. Defibtech MD assures that AED programs have the proper physician prescription, that they meet oversight requirements, and that they concur with government mandates,” said Dr. Laub. He added that Defibtech MD also helps organizations keep abreast of training requirements and ever-changing legal precedents that impact AED programs. “We’re finding that the liability tide is shifting in favor of having AEDs,” he said. Individuals have successfully sued airlines, amusement parks, transit authorities and other organizations because AEDs were not available or because employees did not receive proper AED training, he explains. “If you want to avoid liability, the answer is to have an AED program with proper oversight, training and maintenance.” He added that the nation’s courts have increasingly acknowledged the availability of an AED as a “required standard of care” for employees and citizens in public areas. Medical research also has verified the effectiveness of AED programs. A 2004 study published in the New England Journal of Medicine concluded that public access to AEDs significantly improves the chances of survival from sudden cardiac arrest, which kills up to 325,000 Americans each year. Defibtech relentlessly pursues one goal: making the best AEDs in the world at affordable prices. Defibtech designs and manufactures the Defibtech™ AEDs, which include the Lifeline™ and ReviveR™ models. Defibtech’s products are sold through its network of distribution partners in the United States and around the world. Defibtech is headquartered in Guilford, Connecticut, and manufactures all of its defibrillators in the United States in a state-of-the-art ISO 13485:2003 certified facility. ____________________________

Mercy Hospital Physician First in Miami-Dade to Implant New Insertable Cardiac Monitor, Offering Important Insights into Patients’ Irregular Heart Rhythms

Dr. Alberto Interian Jr., Medical Director of the Mercy Hospital Arrhythmia Syncope Center, is the first doctor in Miami-Dade County to implant an innovative cardiac monitoring device for patients with irregular heart rhythms or recurrent, unexplained fainting. The Medtronic Reveal XT™ Insertable Cardiac Monitor (ICM) device monitors patients 24 hours a day, every day for up to three years, recording important cardiac rhythm trend data that may allow a physician to confirm or rule out an abnormal heart rhythm more definitively than other tests. "Cardiac arrhythmias are unpredictable," said Dr. Interian. "The Reveal XT device gives me a long-term monitoring option that further assists me in making a diagnosis and determining the appropriate treatment for my patients." Physicians may choose the Reveal XT monitor for their patients with suspected arrhythmias in difficult-to-diagnose patients for whom long-term cardiac rhythm trending data may aid in a more informed diagnosis; or in syncope patients with known or suspected atrial fibrillation (AF). The Reveal XT ICM is also an option for physicians seeking to detect the presence of atrial arrhythmias (also known as AT), including asymptomatic episodes, or to monitor the amount of time a patient is in AT/AF to assess whether medical treatment is necessary or should be adjusted. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the device weighs just 15 grams and is approximately the size of a jump drive; unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads or tiny wires that extend from the device into the heart’s chambers. To store an electrocardiogram, a patient places a hand-held, pager-sized assistant over the device and presses a button. The physician can then analyze the stored information, transmitted via the Medtronic CareLink® Network or during an in-office patient visit, and determine whether the episode was caused by an abnormal heart rhythm. ____________________________

Stereotaxis Announces First Uses of the NaviStar® RMT ThermoCool® Catheter

Stereotaxis, Inc. announced that clinicians at two centers in the United States have performed successful cardiac ablation procedures with the NaviStar® RMT ThermoCool® catheter since the announcement of its approval by the U.S. Food and Drug Administration in February. In the first procedure with the magnetic irrigated catheter, Dr. Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, successfully treated a 65-year-old male with persistent left-sided abnormal heart rhythm. "This was a very complicated case," said Dr. Natale. "The procedure was flawless, and the patient is doing extremely well. We are very pleased with the performance of the magnetic irrigated catheter. Now that it is available, we expect to use the Remote Magnetic Navigation System routinely to treat complex arrhythmias. The power of the magnetic irrigated catheter, together with the precision of the Stereotaxis System, represents a significant improvement in the management of complex arrhythmias." In a separate case, Dr. David Tschopp, electrophysiologist at The Heart Hospital of Austin, treated a 72-year-old male patient with atrial flutter. "The performance of the magnetic irrigated catheter was exceptional," said Dr. Tschopp. "We were able to deliver the necessary therapy, and the patient is doing extremely well. I believe that the combination of remote magnetic navigation with the irrigated catheter will have the greatest, most immediate impact on treating complex left-sided ablations. It is exciting for this tool to be available to the millions of people who have this disease." Prior to FDA approval, Dr. Peter Weiss, MD, MSc at Intermountain Medical Center in Salt Lake City, received a compassionate use exemption to treat a patient suffering from incessant premature ventricular contractions (PVCs) that accounted for over 30% of his heart beats each day. After treatment with the magnetic irrigated catheter, the patient’s PVCs were reduced to less than 5% of his total heart beats. The patient had failed medications and two previous attempts at catheter ablation. "The details of our case at Intermountain demonstrate the full power of an irrigated catheter combined with the precision of magnetic navigation," said Dr. Weiss. "We were able to maneuver the catheter into very difficult-to-reach anatomy, achieve excellent tissue-catheter contact, and successfully treat this complicated patient where other treatments had failed. This has been an extremely gratifying case and we look forward to broader and more consistent application of the magnetic irrigated catheter for complex cases at our Center going forward." "Everyone at Stereotaxis has been preparing for the introduction of the magnetic irrigated catheter in the U.S.," said Mike Kaminski, Stereotaxis President and CEO. "With these first cases we have begun with our partner a phased rollout to our installed base of Niobe systems, and we are working very diligently to be certain each center has the training and resources it needs to deploy the catheter with success. We’re looking forward to seeing a broader presentation of clinical experiences at the Heart Rhythm Society’s annual meeting in May." ____________________________

Stabenow, Murkowski, Capps and Bono Mack Reintroduce HEART for Women Act

In a struggling economy that could force some women to make tough choices on healthcare, Senators Debbie Stabenow (D-MI) and Lisa Murkowski (R-AK) and Congresswomen Lois Capps (D-CA) and Mary Bono Mack (R-CA) reintroduced legislation that would expand access to screening and lifestyle counseling for low-income and uninsured women, including those who may have recently lost their jobs and health benefits. The Heart disease Education, Analysis and Research and Treatment (HEART) for Women Act would expand eligibility for funding to all 50 states for the Centers for Disease Control and Prevention's WISEWOMAN screening program for low-income, underinsured uninsured women. Currently the program is available in only 20 states. The legislation would educate both women and health care providers about the prevention and diagnosis of heart disease in women and the most effective treatments. It would also tighten Food and Drug Administration requirements for reporting sex and race-based data about new medicines and devices. "Heart disease is the number one killer of women in this country," said Senator Stabenow. "Too many of our daughters, mothers, and grandmothers are falling victim to this terrible disease. But the reality is that a majority of women and physicians are unfamiliar with the symptoms, diagnoses, and dangers of heart disease in women. The HEART for Women Act will help educate women and their doctors, increase access to screenings for women, and expand gender-specific analysis and research, so we are better equipped to fight this disease and save lives." "Cardiovascular disease, often called the 'silent killer,' takes the life of one woman nearly every minute," said Senator Murkowski. "The HEART for Women Act uses a multi-pronged approach — arming medical providers with the safest and most effective cardiovascular treatments for women and giving more women access to the WISEWOMAN program that provides free heart disease and stroke prevention screening to low-income, uninsured women. Passage of this legislation will ensure that providers have greater access to life-saving drugs and screening services to prevent the rise of cardiovascular disease in women." "While we have made great progress in the fight against heart disease, it remains the number one killer of American women, needlessly claiming the lives of far too many of our mothers, sisters, and daughters," said Representative Capps, a registered nurse. "Unfortunately not enough people — including health professionals — recognize that heart disease poses such a serious threat to women's health and far too many women pay a terrible price for that lack of knowledge. Our legislation addresses the critical knowledge gap by ensuring that health care professionals are informed about the risks of cardiovascular disease in women, know how this disease affects women differently than men, and are better equipped to diagnose heart disease in women.” She continues, "By providing access to high-quality screenings for heart disease and stroke, we can help women across the country secure an early diagnosis of the disease and receive effective treatment." "Women need to be more aware about what they can do to prevent and treat heart disease and lead healthier lives," said Representative Bono Mack. "Heart disease is the leading cause of death in women in our country. While more and more men are seeking treatment for cardiovascular diseases, a significantly smaller percentage of women are getting the help they need. This legislation addresses this disparity through a multifaceted approach that will improve prevention, diagnosis and treatment of heart disease and stroke. I am proud to join my colleagues in this important effort that could save millions of lives." The HEART for Women Act is endorsed by a number of leading health and women's organizations, including the American Heart Association/American Stroke Association, WomenHeart, the Society for Women's Health Research, and the Association for Black Cardiologists. "Women's heart health is of utmost importance, especially during a time when Americans are likely foregoing medical care and preventive services because of the sluggish economy," said Timothy J. Gardner, MD, American Heart Association President. "We simply cannot afford to let more women die needlessly from a largely preventable disease. The reintroduction of the HEART for Women Act will help ensure that low income, uninsured and underinsured women have access to free CVD screening and lifestyle counseling to help combat this deadly disease." "The Society for Women's Health Research feels strongly that the HEART for Women Act will finally require the FDA to provide women with the important information they need regarding sex and race based differences in new medicines and devices," said Phyllis Greenberger, M.S.W., President and CEO, Society for Women's Health Research. "The HEART Act will improve the lives of women with heart disease by helping them receive the most appropriate treatment." "A woman is twice as likely as a man to die in the year following a heart attack simply because she is not getting equal care and treatment," said Carol Allred, president of WomenHeart, the only national education and advocacy organization solely dedicated to promoting women's heart health. "The HEART for Women Act is critical legislation that supports WomenHeart's ongoing efforts to level the playing field in heart disease, where women aren't just losing the game; they are losing their lives."