Clinical and Industry News

Medical Ventures Signs Letter of Intent to Acquire Angiometrx Medical Ventures Corporation is pleased to announce that it has signed a letter of intent to acquire Angiometrx Inc. (www.angiometrx.com), a privately owned medical technology company focused on the development and commercialization of the Metricath System. The Metricath System is a catheter-based technology that allows cardiologists to measure arterial size and wall characteristics during interventional treatment of coronary and peripheral artery disease. The Metricath System was developed in response to the limitations of existing measurement technologies, which are either not sufficiently accurate or prohibitively expensive and time-consuming to gain widespread acceptance. The balloon angioplasty (PTCA) catheter market exceeds $500 million worldwide. MEV hopes to capture a significant share of this market by combining the Metricath measurement technology with treatment capability on the same PTCA balloon catheter, at a similar price point to existing standard treatment-only catheters. On this basis, the Metricath technology provides measurement capability to the cardiologist with insignificant additional time or expense to the angioplasty procedure. FDA approval of the Metricath measurement-only catheter is anticipated for mid 2004. Arrangements are underway to begin trials and obtain regulatory approval for the sale of Metricath in Europe. Closing of the transaction is expected on or before May 31, 2003 and is subject to a number of conditions. Homocysteine Tied to Heart Failure A new study finds high blood levels of the protein homocysteine are associated with congestive heart failure, and there are strong hints in the report that they cause the deadly condition. That last point is crucial. The American Heart Association’s official stand is that while several studies have established an association, high homocysteine levels are not yet called a major risk factor for cardiovascular disease. We don’t recommend widespread use of folic acid and vitamin B supplements to reduce the risk of heart disease and stroke. But several aspects of the study point toward a causal link, says study author Dr. Ramachandran S. Vasan, a senior investigator with the Framingham Heart Study in Boston. First, measurements of homocysteine levels were taken before the participants, 2,491 men and women in the long-running study, began to develop heart disease. Readings of high levels were obtained before the onset of heart failure, thus establishing a sequence, Vasan says. And the association was strong, he says. The risk was double for people in the upper 50 percent of blood homocysteine levels than for those in the lower half, and quadruple for those in the upper 25 percent, compared to those in the lowest 25 percent, Vasan says. The risk was elevated even for women whose homocysteine levels are in the range now regarded as normal. Finally, there is biological plausibility to back the belief that high homocysteine levels can cause cardiovascular disease, he says. For example, laboratory studies have shown that homocysteine can have adverse effects on the endothelium. However, the key bit of evidence, a study showing that lowering blood levels of homocysteine will reduce the risk of heart disease, is missing, Vasan says, and that evidence will not be available for some time. There are studies designed to see if lowering homocysteine levels will reduce the incidence of stroke, but none aimed at heart disease, he says. The new study is interesting because it is the first to link high homocysteine levels with heart failure, rather than heart attacks and other cardiovascular diseases, says Dr. Nieca Goldberg, chief of cardiac rehabilitation at Lenox Hill Hospital in New York City and a spokeswoman for the American Heart Association. She, too, points out there is no data available saying that reducing blood homocysteine levels actually reduces the incidence of heart attacks or heart failure. It is premature to tell people to take vitamin supplements to lower blood homocysteine levels, Goldberg says. She recommends that people look at the vitamin B content of a lot of foods, particularly green, leafy vegetables. I do prescribe B vitamins in appropriate patients, Goldberg says. She explains she will prescribe them for some patients with elevated homocysteine levels even if they do not have the traditional risk factors for cardiovascular disease, such as high blood pressure or obesity. However, this is a decision that must be made for each individual patient, Goldberg says. There is a chance that taking too much vitamin B can cause damage in some people, she says. Cardiogenesis Granted FDA Panel Review of Percutaneous Myocardial Revascularization (PMR) System Independent Panel Will Make Recommendation to FDA on PMR Premarket Approval Application CardioGenesis Corporation, focusing on Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR), announced that an independent panel review of the scientific dispute in connection with the Company’s pending PMA application for its Percutaneous Myocardial Revascularization (PMR) System has been granted by the U.S. FDA. The review will be conducted by the FDA’s Medical Devices Dispute Resolution Panel (MDDRP), independent experts authorized to adjudicate and resolve scientific disputes between an applicant and the FDA. CardioGenesis Chairman and CEO Michael J. Quinn said the Company understands the unique challenges an innovative new technology can present to the FDA, and is encouraged by the Agency’s decision to provide an impartial forum for consideration of the evidence by qualified experts. CardioGenesis expects the MDDRP to convene within the second quarter of 2003. The panel will make a determination and recommendation to the FDA's Director of the Center for Devices and Radiological Health (CDRH). The CardioGensis PMR system has been under evaluation in pivotal human clinical trials since 1997. The current PMA application was filed with the FDA in December 1999 and amended in July 2002 to address concerns raised at a FDA advisory panel meeting. Late last year the FDA's Office of Device Evaluation (ODE) determined that, in their opinion, there was not sufficient information to demonstrate reasonable assurance of PMR’s safety and effectiveness. The Company considered all of the potential remedies to this dispute. The formal dispute resolution process provided the most direct pathway to a determination on the PMR supplement by well-qualified clinical experts. The Company will provide further information on the timing of the panel meeting when it is made available. For more information on the Company and its products, please visit https://www.cardiogenesis.com. AXIOM Artis TA Now with Integrated Ultrasound Siemens Medical Solutions will introduce AXIOM Artis TA, a ceiling mounted universal angiography C-arm system, at the 28th Annual Scientific Meeting of the Society of Interventional Radiology (SIR), which was held in Salt Lake City, Utah on March 27-April 1. The new angiography system enables comprehensive routine diagnoses with 3D image quality, radiation protection and network connectivity. The AXIOM Artis TA is designed for vascular and non-vascular diagnostic routines, as well as interventional procedures. The system is suited to the requirements of universal angiography, cardiac angiography, and neuroradiology. It is also equipped with an integrated ultrasound solution. The AXIOM Artis TA features the newest addition to the Siemens product portfolio, the CareShuttle transport system. The patient is prepared for the procedure directly on the CareShuttle tabletop, which can then be moved to the AXIOM Artis TA. While the patient is on the table, the tabletop is attached to the Artis system table, eliminating the need for patient repositioning and detaching vital signs monitoring before and after the procedure. The AXIOM Artis TA has a ceiling-mounted C-arm. The C-arm speed allows for rotational angiography and 3D reconstruction applications. There is an integrated system control box mounted directly at the examination table. Siemens C.A.R.E. (Combined Application to Reduce Exposure) program provides radiation protection for both the patients and technologists. During the examination, copper prefiltering automatically adapts filter strength to the density of the respective body region. Using the Careprofile, collimators and filters can be set for the region of the body to be examined without the use of radiation. Pulsed fluoroscopy also provides dose reduction. Integrated DICOM interfaces in all AXIOM Artis systems provide seamless network connectivity and communication, allowing data exchange with the hospital’s information technology (IT) environment. Multi-modality viewing in the examination room provides the physician with additional diagnostic and therapeutic capabilities, and enables access to images from previous examinations acquired using other modalities. Vascular Access Safety Kit Merit Medical Systems, Inc. introduces its new vascular access safety kit (A.S.K.) designed specifically for radiology and cardiology. The A.S.K. incorporates new shielded technology that helps minimize the risk of sharps and sharps related injuries associated with gaining vascular access. Benefits include: Compliance with the Needlestick Safety and Prevention Act (H.R. 5178) Increased safety from sharps and sharps related injuries One-finger activation of safety mechanism Organization of sterile field Safety Paracentesis Procedure Tray Merit Medical Systems, Inc. also introduces the new Safety Paracentesis Procedure Tray designed to provide the necessary components to perform a paracentesis procedure. Benefits include: The OneStep® centesis catheter with large drainage holes and a smooth tapered tip offers easy access and optimal drainage of fluid. Each kit includes all the components needed to complete a paracentesis drainage procedure. Increased safety from sharps-related injuries - Compli-ance with the Needlestick Safety and Prevention Act (H.R.5178) Available in three different configurations with the choice of a tray without a centesis catheter or a choice of a 5F, 7CM OneStep catheter or a 5F, 10CM OneStep centesis catheter. EECP Demonstrated to be Effective in Patients with Cardiac Syndrome X Vasomedical announced that data demonstrating the efficacy of EECP® therapy in treating patients with Cardiac Syndrome X, also known as microvascular angina, were presented at Clinical Research 2003, the National Meeting of the American Federation of Medical Research, in Baltimore, Maryland on March 8, 2003. Cardiologists Kenneth Kronhaus, MD, of Lake Cardiology and William Lawson, MD, of University Medical Center Stony Brook, State University of New York authored the paper. After treatment with EECP, patients with Cardiac Syndrome X refractory to medical therapy showed an average improvement of 2.6 Canadian Cardiovascular Society angina classes at the completion of a course of therapy in this 12 patient sequential prospective case series. Angina class remained the same or further improved six months post treatment. A resolution of ischemic defects was also demonstrated through a patient’s stress test with diagnostic imaging at an average of 3.7 months after treatment in all patients. It has been reported that approximately 15 to 30 percent of all patients presenting for diagnostic cardiac catheterization with angina symptoms show no evidence of significant epicardial coronary artery disease, said Dr. Kenneth Kronhaus. EECP has been shown in our analysis to be a viable therapy in this patient population, who previously had no alternate treatment option to relieve their angina. External counterpulsation has been studied for more than 40 years as a non-invasive method for the treatment of ischemic heart disease. Additional information is available on the Company’s website at www.vasomedical.com. Teen Gets Piercing-Related Heart Infection A 13-year-old girl who was born with heart disease contracted a life-threatening infection of the membrane lining her heart soon after having her navel pierced, Michigan doctors report. While there are no existing recommendations on whether people with such congenital heart conditions should take antibiotics preventively before having a piercing or tattoo, the researchers note, the girl’s case suggests that they should be warned about the risks of endocarditis. Infective endocarditis, currently the fourth leading cause of infection-related death in the United States, occurs when bacteria or fungus colonizes the valves of the heart. If left untreated, it can lead to a fatal destruction of heart muscle. In recent years, there have been repeated reports of people developing infectious endocarditis after body piercing, the authors note. But this is the first case of a person with a history of congenital heart disease developing the condition after navel piercing, they add. Drs. Jason B. Weinberg and R. Alexander Blackwood of the University of Michigan Medical Center in Ann Arbor report on the case of the 13-year-old girl, who became seriously ill one month after piercing her own navel. The girl went to her doctor when she became very ill with a fever and was admitted to a pediatric intensive care unit. The doctors learned that the girl had been born with a heart malformation that was surgically corrected when she was 3 years old. The girl reported having pierced her navel a month prior to her illness, but said she removed the navel ring two days after performing the piercing because she thought it looked infected. Tests identified an infection with Staphylococcus aureus in one of the valves in her heart. The girl was treated with antibiotics as well as heart surgery and was released from the hospital after 22 days. Since piercing of the navel and other parts of the body do carry a risk of endocarditis to patients born with heart malformations, the researchers note, these patients should be warned of this potential complication, as well as other more common piercing risks. In Case of Heart Failure, Mice Don’t Act Like Men A genetic change that is life-threatening in humans actually appears to improve health in mice, revealing flaws in the standard research approach of studying diseases in mice to shed light on the same diseases in humans. Investigating genetic changes that can affect heart failure, researchers discovered that deleting a gene known as PLN in mice improves heart function. But when the researchers identified humans who had naturally lost the function of that gene, they found the genetic change was associated with early heart failure. Indeed, two people without the active PLN gene needed to undergo heart transplants at the ages of 16 and 27, the authors note. The mouse genome is about 14% shorter than the human genome and similar in content. Despite these genetic similarities, the current study findings show that researchers should always remember that mice are not men, said Dr. Evangelia G. Kranias of the University of Cincinnati College of Medicine in Ohio. Although the mouse has offered us a model system that has provided us with an enormous amount of information on the function of various genes, we should be cautious in designing therapeutic approaches based exclusively on results of studies in mouse models, Kranias said. The gene in question, PLN, encodes for a protein known as phospholamban, which regulates the movement of calcium through the heart. Experiments with mice who lack PLN reveal that the absence of the protein increases the cycling of calcium through the heart. Mice lacking PLN are healthy, they live as long as normal mice, and they can exercise as well as normal mice, commented the researcher. In order to investigate whether a lack of PLN helps human hearts, Kranias and colleagues identified two people who had grown up carrying a genetic pattern that left them without the PLN protein. In contrast to what is seen in mice, the two people without PLN developed severe heart failure, both needing heart transplants before age 30. One patient, who received a new heart at the age of 17, died soon after the surgery. In terms of why, in this instance, mice and humans differ, the researcher said that the mouse heart beats around 10 times faster than the human heart, and calcium cycles very quickly through the mouse organ. The relatively slow-beating human heart, in contrast, needs a large cardiac reserve to get it through periods of exercise or stress, Kranias noted. PLN may provide this cardiac reserve in humans and thus, PLN is a requirement for proper cardiac function in humans, he said. Demographic Changes Direct the Growth of Interventional Cardiology Markets A significant increase in the aging population and unhealthy lifestyle habits such as smoking, poor diet, and lack of exercise are driving the demand for interventional cardiology products in the United States. New analysis from Frost & Sullivan’s (www.frost.com) U.S. Interventional Cardiology Markets reveals that this market generated revenues worth $2.11 billion in 2002 and is likely to reach $4.67 billion in 2006, driven primarily by the launch of drug-eluting stents likely to begin in 2003. With population over the age of 65 expected to grow by 50 percent in the next 30 years, there will be a significant demand for products used in cardiovascular procedures such as angioplasty, stenting, and vascular closure. Argatroban Assigned Medicare and Medicaid Ambulatory Payment Classification Code GlaxoSmithKline and Texas Biotechnology Corp. announced the anticoagulant Argatroban has been assigned Ambulatory Payment Classification (APC) code G9121 by the Centers for Medicare and Medicaid Services. The new APC code will provide Medicare and Medicaid reimbursement for Argatroban use in patients with or at risk for heparin-induced thrombocytopenia (HIT), undergoing hospital outpatient percutaneous coronary interventions (PCI). Argatroban is already reimbursed for most inpatient PCI procedures. With the new code, hospitals will be able to bill both for actual product used and for necessary product discard. Argatroban, a direct thrombin inhibitor, is indicated as an anticoagulant for prevention or treatment of blood clots in patients with heparin-induced thrombocytopenia (HIT). Argatroban also is indicated as an anticoagulant in patients with or at risk for HIT undergoing PCI such as balloon angioplasty and the implantation of stents. CryoCor Clinical Progress Update CryoCor, Inc. continues to accumulate clinical experience with its Cardiac Cryoablation System. This growing experience comes from commercial use of the product in Europe and Asia and from clinical trial use in the United States. Most noteworthy from Europe, one customer has declared that over 100 patients have been successfully treated to date with the CryoCor Cardiac Cryoablation System at the Academic Hospital Maastricht in The Netherlands. All of these patients were treated either under the CE Mark clinical trial, or during the initial commercial release of the CryoCor Cardiac Cryoablation System. The physicians, Dr. Luz-Maria Rodriguez, Dr. Carl Timmermans and Professor Harry HJM Crijns, are the first medical group to use the CryoCor System exclusively for all cardiac ablation procedures performed at their center. These 100 patients have suffered from various cardiac arrhythmias, including atrial fibrillation, atrial flutter, and other supraventricular tachycardias. Additionally, these physicians continue to evaluate other applications of the System, including utilization for the treatment of ventricular tachycardia. We are very enthusiastic to have this new treatment for the good of our patients. We see many benefits for our patients and, after overcoming the necessary learning curve, we can apply the new therapy in less time than RF-ablation, said Dr. Luz-Maria Rodriguez, Head of the Electrophysiology Department, Academic Hospital Maastricht. U.S. IDE Clinical Trials for Atrial Flutter and Paroxysmal Atrial Fibrillation Successful experience with the CryoCor Cardiac Cryoablation System in the U.S. for the FDA-regulated treatment of typical atrial flutter and paroxysmal atrial fibrillation continues to accumulate as well. The Company reported that in the U.S. over 20 patients have been successfully treated to-date for atrial flutter with use of the CryoCor System. In addition, the Company has also treated over 25 patients for paroxysmal atrial fibrillation. These procedures are being performed as part of feasibility studies under Investigational Device Exemptions (IDEs) granted by the U.S. Food and Drug Administration (FDA). Outlining the next steps for the Company in the U.S., CryoCor says that it expects to complete the initial patient enrollment for the atrial flutter feasibility study by 1Q 2003. The Company then will file for FDA approval to proceed with a non-randomized pivotal trial necessary to support a U.S. Premarket Approval (PMA) application to the FDA. Additionally, the Company will continue enrollment and treatment of patients for the paroxysmal atrial fibrillation. For further information, visit www.cryocath.com Medtronic Study of Neurostimulation for Refractory Angina Pain Gets Underway 61-year-old Man from Indianapolis Becomes First U.S. Patient Implanted in STARTSTIM Trial Medtronic, Inc. announced the start of a clinical study of neurostimulation for refractory angina pain. A 61-year-old man from the Indiana capital recently became the first U.S. patient to be implanted with a neurostimulation system in Medtronic's STARTSTIM (Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications) Trial. The first U.S. implant, performed by Dr. Michael Turner at Indiana University Hospital, in association with Dr. Jeffrey Breall at the Krannert Institute of Cardiology at the Indiana University School of Medicine in Indianapolis, marked the beginning of the STARTSTIM Trial. It was approved by the U.S. FDA to evaluate the safety and efficacy of neurostimulation to treat the pain of severe, chronic angina that does not yield to traditional medications or standard surgical procedures. Scheduled to last about two years, the study is expected to involve more than 200 patients at 20 North American medical centers. According to published studies in peer-reviewed medical journals, neurostimulation has shown promise in European studies where chronic angina patients unresponsive to other treatments have experienced pain relief with less medication and fewer visits to the emergency room. Healthcare Institutions Can Take Positive Steps to Ease Critical U.S. Nursing Shortage Study Underscores Areas for Improvement Healthcare institutions can take positive steps to increase existing low levels of employee commitment, beginning to stem the critical shortage of nurses in the U.S. says a study released by Taylor Nelson Sofres (TNS) Intersearch, a market research firm (www.intersearch.tnsofres.com). The study showed that an alarming majority of U.S. Healthcare workers (52 %) admit to having a low level of commitment to the job they do and the institutions they work for. In a nation where healthcare is compromised by the lack of nurses, focusing on improving employee commitment can help improve the quality of healthcare and ease the nurse shortage, says Jason Palmer, vice president, TNS Intersearch Healthcare Practice. To do so, hospitals and health systems need to look beyond mere job satisfaction ratings and assess the deeper issues that relate to employee commitment such as rewards and recognition, respect from their superiors, understanding the strategic direction of the company and the quality of senior management. The healthcare study was part of a larger global workplace study that surveyed 20,000 workers across 33 countries. Approximately 20 percent of the U.S. respondents worked in the healthcare industry. The TNS study is the first study to focus on commitment, which is a proven link between turnover, productivity and time missed from work. The TNS study uses a series of behavioral and attitudinal questions called EmployeeScore1 to fully understand the relationship between employees, their job and the company. As such, the study classified heathcare workers into four different groups: Ambassadors (46 percent): The most committed; those who are fully committed to the company and to their work. Company Oriented (5 percent): The next most committed group, which includes those who are fully committed to their company more so than their work and career. Career Oriented (26 percent): Includes those who are more interested in furthering their career and their needs over the needs of the company. Disengaged (26 percent): The employee segment that no company wants, but has in abundance. They are neither committed to their company or to their career. In contrast to employees in twelve other industries studied, the healthcare industry has the highest percentage of Career oriented (26 vs. 20 percent) and the lowest percentage of Company oriented (5 vs. 8 percent) These commitment levels indicate that healthcare employees are dedicated to their profession, but workplace issues thwart commitment to the employer. Many become disillusioned and leave the profession, notes Mr. Palmer. Of even greater concern is the erosion of the highly committed; if workplace issues are not corrected, the percentage of Ambassadors could fall, contributing to the shortage. Workplace issues can be addressed by: (a) focusing on development and advancement opportunities to motivate employees; (b) ensuring a good workplace setting that enables them to do their jobs; (c) encouraging management to show concern for them as employees; (d) developing focused communications from the top down and bottom up. Employees that are committed lead to lower turnover, which ultimately has a positive impact on the bottom line. Hence, it is essential for today’s leading healthcare companies to precisely target attitudes and behaviors that impact an employee’s commitment to the company.

NULL