St. Jude Medical Announces European Approval Of Smaller, Higher Power ICD And CRT-D Devices With New Heart Failure Monitors
St. Jude Medical, Inc. (NYSE:STJ) announced European CE Mark approval and first implants of its Fortify(TM) and Fortify ST implantable cardioverter defibrillators (ICD) and Unify(TM) cardiac resynchronization therapy defibrillator (CRT-D). The devices will be fully launched in Europe later this spring, and U.S. versions of the Fortify ICD and Unify CRT-D are expected to be launched later this year. The reduced size of these new devices compared to those of previous generations creates the smallest available device footprint in the industry. The Fortify ICD and Unify CRT-D feature advanced battery technology and circuitry that allow for a smaller device, with more energy capacity and rapid charge times, all while increasing device longevity. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection-fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm).
Bioheart Launches First US FDA Approved Clinical Trial That Tests Gene-Modified Stem Cell Therapy In Patients With Congestive Heart Failure
Bioheart, Inc., (OTCBB:BHRT) announced that the company has commenced work on its REGEN trial, a Phase I Clinical Trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). Bioheart's MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells, that are grown from a patient's own muscle. MyoCell® has been tested successfully on patients in four clinical trials. The REGEN trial is designed to test the safety and effectiveness of a composition of muscle stem cells that have been gene-modified to induce a greater than usual release of the SDF-1 protein. The SDF-1 protein is a molecule in the human body that, after an injury, is naturally released by most tissues to attract stem cells. The stem cells assist with the healing process. Unlike other tissues, the heart muscle does not release enough SDF-1 to attract the number of stem cells that would result in complete self-healing. As a result, scar tissue forms and impairs normal heart function.
MAQUET Cardiovascular Announces Long-Term Follow-Up Data From Landmark 'SMART' Study Reinforce Positive Results For Patients Undergoing OPCAB
MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced that long-term results from the landmark SMART (Surgical Management of Arterial Revascularization) study will be presented tomorrow to attendees of the Society of Thoracic Surgeons's 46th Annual Meeting by John Puskas, M.D., Chief of Cardiac Surgery, Emory Crawford Long Hospital, Associate Chief of Cardiothoracic Surgery, Emory University, and SMART Study lead investigator. The data provide confirmation of the efficacy of performing Coronary Artery Bypass Graft surgery (CABG) while the patient's heart continues to beat a procedure known as Off-Pump Coronary Artery Bypass (OPCAB). Initiated in March 2000, the SMART study was the first randomized U.S. trial to compare OPCAB with conventional on-pump CABG surgery (in which the patient's heart is stopped and a machine takes over the work of the heart and lungs). Long-term follow-up data collected from SMART study patients confirm that outcomes are similar based on an analysis of early- and late-graft patency (freedom from blockage), incidence of recurrent heart attack, need for re-intervention, and long-term survival between the two procedures at a mean of nearly eight years after surgery.
In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). This innovative medical device is the first transcatheter heart valve to receive FDA approval. Delivered through a catheter requiring only a small incision, the Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve, which is the valve between the heart and lungs. These patients often require open-heart surgery to restore effective blood flow to their lungs. Previously, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries. To date, more than 1, 100 patients worldwide have received a Melody valve. "The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease - many of whom are young and will require several heart surgeries over their lifetime, " said pediatric cardiologist Dr.
Congenital heart defects (CHD) are the most common birth defects in humans, affecting 8 per 1000 live births with one-third of affected children requiring intervention in early infancy. Increasing numbers of survivors combined with developmental expectations for independence, behavioral self-regulation and academic achievement have led to a growing identification of neurobehavioral symptoms in some survivors. A study now suggests that a cooling technique often used in heart operations does not impair neurological outcomes. Congenital heart disease and its treatment were originally thought to potentially increase neurologic injury in these patients. The technique of deep hypothermic circulatory arrest (DHCA) is used in order to repair these congenital cardiac defects by providing a bloodless surgical field, which may facilitate completion of the best physiologic repair, and decrease the duration of blood exposure to the bypass circuit. However, it involves a period of reduced blood flow in the brain.
Cardium Provides Update On Commercial Development Plans For Generx Angiogenic Therapy For Heart Disease At 2010 Cell Gene Therapy Forum
Cardium Therapeutics (NYSE Amex: CXM) reported that its Cardium Biologics division provided an update on plans for the continuing commercial development of Generx™ (alferminogene tadenovec, Ad5FGF-4), a DNA-based angiogenic therapy product candidate for patients with coronary artery disease. The update was presented by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer at the annual 2010 Cell & Gene Therapy Forum in Washington, D.C. on January 25, 2010. Cardium Biologics reported on the following findings and plans: (1) As previously announced, based on an agreement with the FDA, Generx would be re-formulated to increase its shelf life, and further formulation enhancements are expected to allow for storage using a standard freezer (rather than at -70 degrees C), and potentially a lyophilized version for refrigerated storage. (2) Based on clinical and pre-clinical findings, angiogenic therapy appears to lead to long-term functional improvements in cardiac microvascular circulation, and Cardium believes that cardiac perfusion (as measured by SPECT) appears to be an important efficacy endpoint to consider that is now supported by a 10-year study of the cardio-protective nature of collateral circulation (Meier et al.
Atrial Fibrillation Treatment Using Specialized Catheter Results In Better Outcomes Compared To Drug Therapy
Use of catheter ablation, in which radiofrequency energy is emitted from a catheter to eliminate the source of an irregular heartbeat, resulted in significantly better outcomes in patients with paroxysmal atrial fibrillation (intermittent cardiac rhythm disturbance) who had not responded previously to antiarrhythmic drug therapy, according to a study in the January 27 issue of JAMA. Atrial fibrillation (AF) represents an important public health problem, with patients having an increased long-term risk of stroke, heart failure and all-cause death. Although antiarrhythmic drugs are generally used as first-line therapy to treat patients with AF, they are associated with cumulative adverse effects over time and their effectiveness remains inconsistent, according to background information in the article. Catheter ablation has become an alternative therapy for AF. David J. Wilber, M.D., of Loyola University Medical Center, Maywood, Ill., and colleagues conducted a study to compare catheter ablation with antiarrhythmic drug therapy (ADT) in patients with symptomatic paroxysmal AF who previously did not respond to at least one antiarrhythmic drug.
Researchers at the PontifГ cia Universidade Catolica do Parana and Instituto Carlos Chagas have evaluated the therapeutic potential of purified and expanded CD133+ cells human umbilical cord blood (HUCB)-derived in treating myocardial infarction by intramyocardially injecting them into a rat model. Patients who have high cardiovascular risks have fewer endothelial progenitor cells (EPCs) and their EPCs exhibit greater in vitro senescence. HUCB-derived EPCs could be an alternative to rescue impaired stem cell function in the sick and elderly. The results, which appear in the January 2010 issue of Experimental Biology and Medicine, show that expanded cells ex vivo exhibited increased expression of mature endothelial cells markers and formed tubule-like structures in vitro. Only the expanded cells expressed VEGF mRNA. Cells were expanded up to 70-fold during 60 days of culture, and they retained their functional activity. A significant improvement was observed in left ventricular ejection fraction for purified and expanded cells.
Virginia Tech researcher Pavlos Vlachos and his students in the College of Engineering have a tall order to tackle: Stem the grim progression of heart disease, which kills hundreds of thousands of people each year in the United States alone. Vlachos, an associate professor of mechanical engineering and director of the Advanced Experimental Thermofluid Engineering Research Laboratory, is waging this fight with what he calls his four children. That's not a condescending term for his researchers, but a parental pride in the series of cardiac-related projects he's working on. Vlachos literally treats these research projects as a parent would treat his or her children. "I can't just talk about one, " he says of the lab experiments. Their initiative areas are wide and include better understanding the flow of blood in and out of the heart; improving drug delivery and artery stents; and creating a system that can mimic the sounds of a diseased heart in order to develop sensors that, from vibrations, can form a diagnosis.
The U.S. Food and Drug Administration approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery. Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. Patients with congenital heart defects have narrowed, leaky, or missing pulmonary valves that impede the proper flow of blood from the heart's right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement. "The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition, " said Jeffrey Shuren, J.