Boston Scientific : First Patient Enrollment in MultiSENSE Clinical Trial

July 8, 2010 - Boston Scientific Corporation (NYSE: BSX) announced enrollment of the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company's COGNIS™ cardiac resynchronization therapy defibrillators (CRT-Ds). Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure. The first patient was enrolled by Paul Coffeen, M.D., Austin Heart, Austin, Texas, where Jeffrey Whitehill, M.D., Medical Chair, Electrophysiology Department, is the site's Principal Investigator.
When combined with the Company's LATITUDE® Patient Management System, CRT-D sensors would be able to monitor a patient outside of a clinical setting and permit the LATITUDE system to deliver early notification to the physician when the patient's heart failure worsens.
"Heart failure is a complex disease and physicians use a number of diagnostics to assess a patient's condition and disease progression,"... Boston Scientific's Press Release -

BSP granted CE mark for its HyperQ AD-100 product enabling improved diagnostic performance of Stress ECG

June 27, 2010- BSP announced that the CE mark was granted to its HyperQ AD-100 and HyperQ-AN products.

BSP, which develops and commercializes advanced products for the non invasive, accurate diagnosis of heart diseases, announced that its Add-On product, the HyperQ AD-100, intended for improved diagnostic performance of Stress ECG, has been granted the European CE conformance mark. The HyperQ AD-100 product is an add-on system with the HyperQ technology which is incorporated in parallel to existing standard stress ECG systems. The integration of the HyperQ AD-100 into Stress ECG systems enables accurate and sensitive diagnosis of Ischemic Heart Disease, a leading cause of death in the world.

The unique technology developed by BSP is implemented in a non invasive manner and does not involve exposure to radiation or other hazards to patients. It is highly effective in diagnosing sick people and in ruling out disease in healthy individuals. The HyperQ AD-100 enables physicians to benefit from the clinical advantages of the technology without the need to replace their existing installed Stress ECG system... BSP 's Press Release -

Acorda Therapeutics : Receipt of NIH Grant for Development of GGF2 in Heart Failure

Jul 20, 2010 -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced the National Heart, Lung, and Blood Institute (NHLBI) has awarded a $1 million Cardiac Translational Research Implementation Program (C-TRIP) grant to support research on Glial Growth Factor 2 (GGF2), a novel investigational agent for the treatment of patients with heart failure under development at Acorda. The grant, supporting both clinical and laboratory studies, was awarded jointly to Acorda and Vanderbilt University Heart and Vascular Institute, which are collaborating on research of GGF2 in heart failure. The first clinical study for GGF2 in patients with heart failure is expected to begin in mid-2010.

"Collaboration is often critical to important scientific advances, and we are excited to be working with Vanderbilt University Heart and Vascular Institute, a leading cardiac treatment and research center, to explore the use of GGF2 in heart failure,"... Acorda Therapeutics' Press Release -

Cardiome : Investigational BRINAVESS™ (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for ...

June 25, 2010 - Investigational BRINAVESS™ (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for the Rapid Conversion of Recent Onset Atrial Fibrillation — Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS™ (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant. The proposed indication for vernakalant is for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.



Granting of marketing authorization by the European Commission is expected later this year and will apply to the 27 countries that are members of the EU plus Norway and Iceland. If approved by the European Commission, vernakalant would be the first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU... Cardiome Pharma's Press Release -

Pfizer : Caduet Reduces 10-Year Calculated Risk Of Coronary Heart Disease, Fatal Cardiovascular Disease

June 21, 2010 – Caduet® (amlodipine besylate/atorvastatin calcium) was associated with a significantly reduced calculated 10-year risk of coronary heart disease (CHD) based on a Framingham risk assessment model. In addition, Caduet was shown to reduce calculated fatal cardiovascular disease (CVD) risk, as a secondary trial endpoint based on the SCORE risk assessment model. The Framingham and SCORE risk assessment models are widely used in the U.S. and EU, respectively. These data from the CRUCIAL (Cluster Randomized Usual Care vs. Caduet Investigation Assessing Long-term Risk) trial were presented yesterday at the 20th Scientific Meeting of the European Society of Hypertension (ESH) in Oslo, Norway.

“The data presented at ESH are important because they show the potential benefit of Caduet, which combines blood pressure and cholesterol-lowering medications in a single pill, over usual care in a real-life clinical setting... Pfizer's Press Release -

St Jude Medical : Acquisition of LightLab Imaging

Jul 06, 2010 - St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, completed the previously announced acquisition of LightLab Imaging, Inc. for approximately $90 million in cash.
LightLab is the pioneer and leader in the development of Optical Coherence Tomography (OCT), a high resolution diagnostic coronary imaging technology which aids physicians in the treatment of cardiovascular disease.

The acquisition of OCT technology accelerates the expansion of St. Jude Medical's cardiovascular growth platform by providing the company with a comprehensive product offering that will allow the Company to compete in, and potentially expand, the intravascular imaging market. The IVUS market is estimated to be $500 million for 2010 and to grow 10 to 15 percent annually.

During the second half of 2010, St. Jude Medical expects the OCT platform to contribute an additional $20 million in revenue to its cardiovascular business. The OCT market is expected to grow at a double-digit compounded annual rate over the next five years and is expected to capture IVUS market share... St. Jude Medical's Press Release - [PDF] LightLab Imaging's Press Release -

Cardio3 BioSciences : Positive Three‐Month Data from its Clinical Trial of C‐Cure® in Heart Failure

June 29, 2010 - Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular diseases, announces positive safety data and preliminary efficacy results from its clinical trial of C‐Cure®, a breakthrough stem cell therapy for heart failure.
Results showed C‐Cure to have a very good safety profile with no adverse events related to C‐Cure, as assessed by an independent board. The study is also examining a number of measures of efficacy. With three month follow up data in‐hand, Cardio3 BioSciences has observed positive and encouraging trends in a number of physiological and clinical parameters. Meaningful differences were seen in ventricular size, ejection fraction and other measures of heart muscle activity in C‐Cure treated patients when compared to control and to baseline. Partial data from a paired analysis of patients at six‐months follow‐up is suggestive of these beneficial trends being reinforced over time. Cardio3 Biosciences intends to publish the study results once the full six month dataset is available and has been analysed... [PDF] Cardio3 BioSciences' Press Release -

Anthera Pharmaceuticals : First Patients in Pivotal Varespladib Phase 3 Clinical Study

June 23, 2010 - Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, announced patient enrollment has commenced in the Company's pivotal VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) Phase 3 clinical study of varespladib (A-002). High-risk patients are defined as those who have additional disease characteristics that increase their likelihood of experiencing another coronary event; these characteristics include a history of previous cardiovascular disease, age, diabetes, or metabolic syndrome.
"Current best practice to slow coronary artery disease (CAD) progression and reduce the risk of a subsequent cardiovascular event is directed at the treatment of individual cardiovascular risk factors such as high cholesterol or clotting. The VISTA-16 study with varespladib is designed to validate the hypothesis that reduction of inflammation, particularly following an ACS, leads to improved outcomes in patients with cardiovascular disease. The enrollment of patients in VISTA-16 is an important milestone for the development of varespladib,"... Anthera Pharmaceuticals' Press Release -