Cardiac Science : MTWA Module for Stress Testing

Sept 21, 2010 - Company Extends Leadership in Stress Category - Cardiac Science Corporation (Nasdaq: CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, announced the launch of a Microvolt T-Wave Alternans (MTWA) module that integrates with its industry-leading Quinton Q-Stress cardiac stress systems.

"Physicians that have Q-Stress systems can add the MTWA module to their existing Q-Stress systems, or order it as an option with new systems," said Tony Titus, Cardiac Science vice president of marketing. "The MTWA test is a clinically proven test for assessing the risk of sudden cardiac arrest and it can be performed during a standard stress test session. It is the only test of its kind that Medicare will reimburse... Cardiac Science's Press Release -

Edwards Lifesciences : Approval to Begin U.S. Clinical Trial of Next-Generation Transcatheter Valve

September 23, 2010 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Food and Drug Administration (FDA) conditionally approved the first of two planned cohorts of the randomized, controlled The PARTNER II Trial. Building upon the learnings of the world's first randomized transcatheter heart valve trial -- Edwards' The PARTNER Trial -- the first cohort of The PARTNER II Trial will study the next-generation Edwards SAPIEN XT transcatheter heart valve. This trial includes the low-profile NovaFlex transfemoral delivery system, which broadens the number of eligible patients... Edwards Lifesciences' Press Release -

Sanofi-aventis : Largest Atrial Fibrillation Registry Reveals Poor AF Control and High Rates of Cardiovascular Hospitalization

September 1, 2010 - Over 10,000 Patients Included in RealiseAF – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that results from the RealiseAF (Real-life global survey evaluating patients with Atrial Fibrillation) registry show that control of atrial fibrillation (AF) (defined by the 2006 ACC/AHA/ESC AF guidelines as either sinus rhythm or AF with heart rate at rest ≤ 80 bpm) was not achieved in more than 40 percent of the AF patients included in this 10,000 patient cross-sectional registry, as presented during the European Society of Cardiology Congress in Stockholm, Sweden. In addition, the registry revealed that a majority of patients complain of symptoms, even when AF is controlled (55.7 percent).
Importantly, cardiovascular (CV) events were very frequent in this population, with a high rate of concomitant CV risk factors (72.2% of patients were hypertensive and 46.3% of patients had dyslipidemia) 28.7 percent of AF patients suffered from CV events such as acute coronary syndrome (ACS) acute heart failure or stroke, leading to an unplanned hospitalisation during the last 12 months and 12.4 percent of patients requiring major CV interventions such as Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG) or valvular surgery... [PDF] Sanofi-aventis' Press Release -

Cardica : Multi-Vessel Minimally-Invasive Cardiac Bypass Surgery Using Automated Stapling Devices

Sept 14, 2010 - Nationally-renowned cardiovascular and thoracic surgeon Mahesh Ramchandani, M.D. of the Methodist DeBakey Heart & Vascular Center in Houston is innovating minimally-invasive cardiac surgery using Cardica, Inc.'s (Nasdaq: CRDC) C-Port(R) Distal Anastomosis and PAS-Port(R) Proximal Anastomosis Systems. Dr. Ramchandani offers patients an alternative to traditional "open chest" bypass procedures without cutting the sternum using the minimally-invasive cardiac surgery/coronary artery bypass graft (MICS CABG).

"MICS is not just a surgical procedure, it is an attitude towards minimally-invasive cardiac surgery, taking a logical, structured, step-wise approach with patient safety as its paramount concern... Cardica's Press Release -

Cardiovascular Systems : First Patient in ORBIT II Coronary Clinical Trial

May 26, 2010 - Pivotal Study Evaluating the Clinical Benefits of Treating Calcified Coronary Lesions with the Diamondback 360° System – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360® System in treating coronary arteries. The patient was treated by Dr. P.K. Khanna, an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. Dr. Khanna also treated patients in the 2008 ORBIT I coronary study of 50 patients in India. ORBIT I showed that the Diamondback 360° was successful in 98 percent of patients with calcified lesions, with an acute procedural success rate of 94 percent.

“Severely calcified coronary lesions have frequently been excluded from other clinical studies over the past decade because they are a clinical challenge for coronary interventions,” Dr. Khanna said. “I believe that the Diamondback 360° is an essential advancement in treating patients with this type of disease. This easy-to-use tool should prove — through the ORBIT II trial — to be safe and effective in treating calcified lesions in order to facilitate stent placement.”

The ORBIT II study advances CSI’s progress toward U.S. regulatory approval for a coronary application and a significant market expansion. CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010. The pivotal trial will initially enroll up to 100 patients, with the potential to enroll up to 429 patients... Cardiovascular Systems' Press Release -

Cardioxyl Pharmaceuticals : Dose-Defining Phase IIA Study of Its Lead Candidate, CXL-1020, in Heart Failure Patients

August 26, 2010 - Following Positive Results in Phase I/IIa Dose Escalation Trial, Cardioxyl Continues to Evaluate Clinical Safety and Tolerability of CXL-1020 – Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure (ADHF). ADHF is the leading diagnosis for patients at the time of discharge from U.S. hospitals and the most common cause of hospitalization for patients over 65 years of age.
"Following the significant clinical results from our recently completed Phase I/IIa dose escalation study demonstrating CXL-1020's attractive hemodynamic and safety profile, we are excited to continue to evaluate this important new therapy for patients with ADHF,"... Cardioxyl Pharmaceuticals' Press Release -