• Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) reported entering into a research agreement with the University of Rochester (Rochester, New York) to participate in a National Institutes for Health-funded investigation into “Risk Stratification in MADITT II Type Patients.” ART’s signal-averaging electrocardiogram (SAECG) analysis software will be used to assess the presence of cardiac late potentials in patients enrolled in the study in conjunction with other noninvasive cardiac tests. ART will provide hardware (ART 1200 EPX) and software – including its Windows-based Predictor SAECG analysis – to support the signal-averaged ECG aspect of this study. In addition, ART is providing monetary support for the acquisition of the signal-averaged ECG and the analysis of the data.
Objectives of this study are to evaluate the predictive value of a multivariate model consisting of pre-specified clinical and ECG parameters for predicting arrhythmic events in Multicenter Automatic Defibrillator Implantation Trial II (MADIT II)-type post-infarction patients; and to develop a multivariate risk-stratification model, based on a spectrum of clinical covariates and ECG parameters, and from it a risk-scoring algorithm identifying high- and low-risk patient groups. Such an algorithm, ART said, will enable an ordering of patients who may benefit most, and benefit least, from implantable cardiac defibrillator (ICD) therapy.
Based on experience from MADIT II, the study will investigate a combination of clinical variables and noninvasive ECG parameters that will indicate the contribution of different electrophysiological mechanisms that predispose a patient to the risk of ventricular arrhythmias and sudden cardiac death. The study will enroll about 800 patients at more than 20 medical research centers over the next 24 months. The study will focus on patients who currently receive ICD’s for MADITT II indications while excluding patients with atrial fibrillation, a paced ventricular rhythm, a QRS duration greater than 120 ms, and New York Heart Association Class III heart failure who are candidates for resynchronization therapy. The patients will be followed for three years.
• CardioDynamics (San Diego), focused on impedance cardiography (ICG) technology, reported that it has entered into a three-year, multi-source contract with Premier Purchasing Partners, the group purchasing division of Premier (also San Diego) for noninvasive cardiology equipment. CardioDynamics said it is the only supplier awarded in the sub-category of ICG equipment.
• Estech (San Ramon, California) reported entering into a U.S. distribution agreement with Neoprobe (Dublin, Ohio) for Estech’s Cardiosconix Quantix/OR blood flow measurement system. The Quantix/OR is designed to provide surgeons with quantitative hemodynamic information in coronary artery bypass graft [CABG] and carotid endarterectomy procedures.Estech offers tools for least invasive techniques and traditional approaches to coronary artery bypass, valve surgery, atrial ablation and surgical treatment of congestive heart failure. Neoprobe develops surgical and diagnostic products.
• Novation (Irving, Texas) has signed an agreement that continues to make Eastman Kodak’s (Rochester, New York) radiographic films, laser media, laser imagers and services available to more than 2,500 members of VHA (also Irving) and University HealthSystem Consortium (UHC; Oak Brook, Illinois). Under a new three-year dual-source agreement, Novation will offer Kodak medical imaging products to VHA and UHC members that include hospitals, non-acute facilities, outpatient imaging centers and private physician offices. The agreement begins July 1, 2006 and is in effect through June 30, 2009. Additional details were not disclosed.
• Sphere Medical (Cambridge, UK/Oudenaarde, Belgium), a developer of next-generation critical care patient monitoring systems, said it has selected AMI Semiconductor (Pocatello, Idaho), a manufacturer of mixed-signal and structured digital products for the medical and industrial sectors, to design and fabricate a sensor interface ASIC for Sphere’s continuous arterial blood gas monitor, in development. The Sphere real-time blood gas monitoring solution includes a disposable sensor and AMIS sensor interface ASIC, enclosed in a standard IV tubing set. The blood gas measurements are output to a small bedside monitor. This continuous monitoring approach offers advantages over central lab console analyzers and portable cartridge-based analyzers by making treatment decision-making faster and therapies managed more effectively, Sphere said. The sensor interface ASIC solution includes a high-performance analog subsection with an ultra-low power analog-to-digital converter, temperature sensor, power management, and a communications interface. AMIS has a network of sales and design centers in North America, Europe and the Asia Pacific region. It serves the device market through a medical and wireless product line group headquartered in Waterloo, Ontario.