Biosense Webster : First Patient In Groundbreaking SMART-AF Trial And Completes First Atrial Fibrillation Ablation Case In The United States

July 14th, 2011 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.

The SMART-AF study is designed to demonstrate the safety and effectiveness of ThermoCool® SmartTouch™, the latest addition to the market-leading and FDA approved NaviStar® ThermoCool® Catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enroll up to 164 patients in leading centers across the United States.

The ThermoCool® SmartTouch™ Catheter is one of the most advanced catheters developed by Biosense Webster to date. During cardiac ablation procedures, the ThermoCool® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. This information is graphically displayed on the CARTO® 3 Mapping and Navigation System, the most advanced 3D Mapping System available on the market today, via the novel Carto® 3 Smarttouch™ Module, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities... Johnson and Johnson's Press Release -

Pegasus : U.S. PATENT FOR ITS HEARTVUE 6S SCREENING DEVICE; TWO EUROPEAN DISTRIBUTORS.

April 19th, 2011 - Pegasus/HeartView LLC, (Symbol: PGUZ-OTC), announced that they have acquired a U.S. Patent Number #US 7,519,416, titled "Diagnostic Method Utilizing Standard Lead ECG Signals" for its HeartVue 6S Screening Device.

This development will now initiate procedures to acquire FDA approval prior to marketing efforts of the system in the United States. The HeartVue 6S System is an advanced technology that analyzes low amplitude ECG oscillations (ECG dispersion mapping) and reports them as myocardial micro-alternation indexes (MMI). The HeartVue 6S System provides a non-invasive assessment of heart disease in 30 seconds, utilizing only 4 limb electrodes. The results are then presented as a color-coded, three dimensional digital heart map, which reflects electrical dispersions.

After acquiring a CE Mark Approval for the marketing of the 6S Screening Device in Europe, the Company has now subsequently appointed two distributors to roll out marketing/sales efforts in their respective territories... [PDF] Pegasus' Press Release -

Sahajanand Medical Technologies : CE mark on Two Sirolimus Eluting Coronary Stents

June 26, 2011. Surat, India - Sahajanand Medical Technologies (SMT) announced that it has received European CE marking for two Sirolimus eluting coronary stent systems; Supralimus® (Sirolimus eluting stents on stainless steel platform) & Supralimus-Core® (Sirolimus eluting stent on chromium cobalt platform).
The CE approval for Supralimus® and Supralimus-Core® brings the company the distinction of being the first in the world to have CE approval for both Sirolimus and Paclitaxel -eluting coronary stents and in total three CE approved drug eluting stents.

“The CE mark for Supralimus® and Supralimus-Core® is a significant accomplishment that substantiates our product’s excellent clinical outcomes. This further confirms our commitment to providing patients and clinicians new treatment options for coronary artery disease.” shared Dhirajlal Kotadia-CEO of Sahajanand, “The excellent flexibility, highly deliverable system and proven safety and efficacy of Sirolimus with the biodegradable polymers make our stents an excellent choice for a variety of patients” he added... [PDF] Sahajanand Medical Technologies -

BIOTRONIK launches Lumax 540 VR-T DX, the world’s only singlechamber ICD with complete atrial diagnostics

June 24, 2011 - A novel solution for optimizing sensor-based diagnostics for patients with cardiac disease - BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices, announced that the innovative new Lumax 540 VR-T DX single-chamber implantable cardiac defibrillator (ICD) and Linoxsmart S DX cardiac lead system will be launched this coming week at the EHRA EUROPACE electrophysiology congress in Madrid, Spain. The Lumax DX system uniquely expands the diagnostic capabilities of the standard single-chamber ICD by integrating special atrial sensors and advanced discrimination algorithms.

The Lumax DX serves a previously unmet need for cardiac device patients who are candidates for a single-chamber ICD. Standard single-chamber ICDs are designed only to sense changes in ventricular rhythm and are unable to correctly sense atrial arrhythmias such as atrial fibrillation (AF) correctly, which increases the risk of inappropriate shock or could potentially result in the patient having a stroke.

“Studies have demonstrated that the lifetime risk of developing AF is 25% in people who have reached the age of 40. Furthermore, out of all ICD and pacemaker patients, it has been shown that more than 13% have a previously unknown AF... [PDF] BIOTRONIK 's Press Release -

GE Healthcare and ImaginAb : Master Research Agreement for Imaging with Antibody Fragments

June 5, 2011 — GE Healthcare Ltd. and ImaginAb, Inc. have executed a master research agreement around the development of new PET (Positron Emission Tomography) diagnostic imaging agents based on ImaginAb’s antibody fragment technology. The agreement is launched with an initial exclusive collaboration around a novel cardiovascular target*.

“We are very pleased to have established this collaboration with GE and particularly delighted that our first project extends ImaginAb’s reach into the rapidly growing market for new PET tracers to image high-risk cardiovascular disease,” said Dr. Christian Behrenbruch, CEO of ImaginAb. “As a development partner, GE Healthcare brings tremendous and much-valued expertise in radiochemistry process development and clinical translation.”


“With the growing importance of biologics-based therapeutics in treating cancer and inflammation and our evolving understanding that cancer and cardiovascular disease are modulated by fundamental immune processes, we view this collaboration with ImaginAb as timely”, said Marivi Mendizabal, Head of Research, GE Healthcare, Medical Diagnostics. “Our vision is that technologies, such as the ImaginAb antibody fragment platform, will enable us to rapidly develop new targeted molecular diagnostics – not just for our own clinical portfolio, but as a ‘companion’ diagnostic offering to antibody/drug conjugat pipelines for our strategic biopharma partnerships”... ImaginAb's Press Release -