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 -

NeuroVive Pharmaceutical : First Heart Attack Patient Treated in European Cardioprotection Phase III trial with NeuroVive’s CicloMulsion

April 19, 2011 - Investigator-initiated European multicenter trial of 1,000 acute heart attack patients will examine the ability of cyclosporine to protect cardiac tissue — NeuroVive Pharmaceutical and Hospices Civils de Lyon (HCL) announced the enrollment and treatment of the first patient in the European multicenter trial of myocardial infarction (the CIRCUS study). NeuroVive’s advanced CicloMulsion™ cremophor-free IV cyclosporine formulation is used in this study of 1,000 patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction to examine cyclosporine’s ability to protect cardiac tissue. The double-blind, placebo-controlled, investigator-initiated study is being led by trial sponsor Professor Michel Ovize, MD, PhD, of HCL. NeuroVive is supporting the study by providing active drug, placebo and drug logistics. The study will enroll patients at 40 centers in France and additional European sites.

Professor Michel Ovize comments:
"Patients with myocardial infarction often undergo emergency percutaneous coronary intervention in which a catheter passed through the major blood vessels restores blood flow to blocked coronary arteries. Even after blood flow is restored, damage to the heart muscle continues to progress through what is known as reperfusion injury. Small-size proof-of-concept studies have shown that reperfusion injury may account for as much as 30-40% of total infarction-related myocardial damage and that timely therapeutic interventions can prevent this damage (Staat et al. Circulation 2005; Thibault et al. Circulation 2008). From a clinical point of view, it is critical to develop a drug to protect cardiac tissue during PCI and hopefully improve clinical outcome.”... NeuroVive Pharmaceutical's Press Release -

Cytori Therapeutics : Sustained Benefits at 18 Months in Cardiac Cell Therapy Heart Attack Trial

06/08/11 -- Cytori Therapeutics (NASDAQ: CYTX) is reporting 18 month outcomes from its APOLLO trial for Acute Myocardial Infarction (AMI). The results from the 14 patient, randomized, placebo-controlled, double-blind safety and feasibility trial in patients with ST-elevation AMI demonstrated the following:

• Mean reduction in infarct size at 6 months was preserved at 18 months for the cell treated group (standard-of-care plus cells), at 11.7% and 11.2%, respectively. In contrast, patients receiving control (standard-of-care plus placebo), exhibited diminished treatment effect from 6 months (6.1%) to 18 months (4.4%) (see Fig. 1);

• The mean reduction in left ventricular infarct size (reduction in the portion of the heart damaged by the heart attack) was statistically significant (p < 0.05) from baseline to 18 months in the cell-treated group. In patients receiving control, there was less improvement which was not statistically significant;

• Statistically significant (p < 0.05) improvement in perfusion of the left ventricle (blood flow through the tissue of the heart) from baseline to 18 months was observed in the cell-treated group. In patients receiving control treatment, there was less improvement which was not statistically significant; and

• There were substantially fewer premature ventricular beats (PVBs) per holter recording in patients who had received cells compared to those who had received control (mean of 24 and 146 PVBs per recording, respectively)... Cytori Therapeutics' Press Release -

Terumo launches its drug-eluting stent, "Nobori," in Japan

May 16, 2011 - Terumo Corporation (Head Office: Shibuya-ku Tokyo; President: Yutaro Shintaku) announced the start of sale of its "Nobori" Drug-Eluting Coronary Stent (DES) in Japan from May.

The product is the first made-in-Japan DES which received approval for its manufacture and sale, based on the clinical trials conducted in Japan.

"Nobori" is the only product in Japan that employs bioresorbable polymer as its drug coating material. In addition, polymer and drug are applied only to the surface to contact vessel tissues.

Terumo Corporation received CE certificate*1 for the commercial sale of the "Nobori" in Europe, in January 2008. It is currently sold in more than 20 countries in Europe, Asia (excluding Japan) and Latin America... Terumo's Press Release -