Results of the Multicenter Automatic Defibrillator Trial II (MADIT-II), a late-breaking clinical trial presented at Heart Rhythm 2009, the Heart Rhythm Society’s 30th annual Scientific Sessions, show a significant reduction in the risk of long-term mortality in patients with an implantable cardioverter defibrillator (ICD) versus patients without an ICD. During an eight-year follow-up period, multivariate analysis demonstrated that ICD therapy is associated with improved survival for patients with serious heart health risks.
The MADIT-II trial enrolled 1,232 patients with ischemic left ventricular dysfunction and follow-up was conducted through November 2001. For the current long-term efficacy study, researchers acquired post-trial mortality data for all study patients from the U.S. and European National Death Registries. Modeling was carried out to determine the long-term outcomes of patients with an ICD versus patients not treated with an ICD.
The first results from the Medtronic Inc., OMNI Study were released at Heart Rhythm 2009, the annual congress of the Heart Rhythm Society, revealing that one out of six patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillators (CRT-Ds) to prevent sudden cardiac arrest (SCA), received potentially life-saving medical therapy — either in the form of anti-tachycardia pacing (ATP) or a shock for dangerously fast heart rhythms — within a period of two years following their implant. Further, the study showed that patients received therapy at similar rates, regardless of whether they meet current medical society guidelines.
Endosense has announced the release of acute clinical results from the TOCCATA (TOuCh+ for CATheter Ablation) European clinical trial at Heart Rhythm 2009, the Heart Rhythm Society’s 30th Annual Scientific Sessions in Boston, May 13-16. The highly anticipated results of the 76-patient, multi-center study confirm the feasibility, safety and value of Endosense’s TactiCath force-sensing ablation catheter during catheter ablation.
TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The TactiCath was granted the CE mark in May 2009.
Cardiologists Edward Tadajweski, MD, and Jeffrey L. Williams, MD, MS, FACC, are the first in the U.S. to perform 3D imaging of complex cardiac anatomy using GE's Innova 3D imaging system. In February 2009, they performed 3D reconstructions on two patients' hearts in the third Interventional Catheterization Laboratory of The Good Samaritan Hospital. The first patient underwent 3D angiography of the coronary sinus to guide a biventricular defibrillator implantation with a left ventricular pacemaker lead. The second patient underwent 3D angiography of the left atrium and pulmonary veins to plan an atrial fibrillation arrhythmia ablation.
The Heart Rhythm Society applauds the introduction of House Resolution 255, which calls for a National Atrial Fibrillation (AF) Awareness Month in September. Introduced by Representative C.A. “Dutch” Ruppersberger (D-MD) and co-sponsored by Kay Granger (R-TX), the resolution will support efforts to raise awareness about AF, which impacts approximately 2.2 million Americans each day, as well as promote prevention and advance optimal patient care.
“The Heart Rhythm Society commends Representatives Ruppersberger and Granger for taking a leadership role in bringing national attention to the serious problem of AF,” said Dr. N.A. Mark Estes III, president of the Heart Rhythm Society. “Currently, less than 30% of AF patients receive the recommended treatment. Therefore, an AF Awareness Month will play an important role in not only raising awareness but also improving patient care and ultimately saving lives.”
St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of the newest version of the Merlin.net™ Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices. This remote care system gathers and stores data from the implant procedure, in clinic follow-up visits or from both patient-initiated and automatic remote follow-up and monitoring transmissions. The updated Merlin.net PCN Version 3.1 expands on features designed to improve clinic efficiency and enhance patient care by giving physicians better and more immediate access to information to help them manage their patients’ devices. With its open architecture and standards-based interface, Merlin.net PCN is also fully integratable with all standard electronic health record (EHR) systems.
Vicor Technologies, Inc. announced that it has entered into a collaborative research agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona to study sudden cardiac death. Vicor Technologies is a development-stage biotechnology company focused on the commercialization of innovative non-invasive diagnostics for sudden cardiac death and trauma using its patented, proprietary PD2i algorithm.
Cardima, Inc. is a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System and the REVELATION® line of therapeutic electrophysiology (EP) catheters. Cardima has successfully completed its second phase of training for cardiothoracic surgeons in Thailand on the use of the Cardima Surgical Ablation System, a true closed chest procedure for the treatment of AF. Cardima’s EP product lines and the Surgical Ablation System have received product registration approval in Thailand.
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.”