ZOLL Medical : Dutch Kijlstra Ambulance BV Equips Entire Fleet With Autopulse Non-invasive Cardiac Support Pump

August 17, 2011 ─ ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced that Kijlstra Ambulance BV, the largest emergency service in the Friesland province of the Netherlands, has purchased 22 AutoPulse® Non-invasive Cardiac Support Pumps to equip its entire fleet of emergency vehicles with the automated chest compression device. Kijlstra is already using the AutoPulse on its two rapid responder vehicles for cardiac arrest and resuscitation.

Erwin de Vos, Kijlstra Project Coordinator, recommended the purchase to senior management after observing that the uninterrupted, high-quality chest compressions provided by the AutoPulse could not be delivered consistently by manual compressions alone. “In our experience, the force and complete thorax compression the AutoPulse administers is superior to manual CPR. The AutoPulse moves more blood more effectively than manual chest compressions, thereby providing the best possible patient care.”

Prior to selecting the AutoPulse, a market research team lead by Edward Jona, MD, Medical Manager of Kijlstra, evaluated the AutoPulse against another automated CPR compression device. The team determined that, in addition to the AutoPulse’s ability to maintain myocardial and cerebral perfusion, it offered a high level of safety for both the patient and paramedic, indicating the device’s effectiveness in keeping both patients and rescuers safe in the back of a moving ambulance... ZOLL Medical's Press Release -

Thoratec: Acquisition of Medical Business of Levitronix

Aug. 3, 2011 - Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced that it has acquired the medical business of Levitronix LLC ("Levitronix Medical") for an upfront cash payment of $110 million, as well as potential future cash earnout payments of up to $40 million. This transaction solidifies Thoratec's position as the leading, full-line provider of mechanical circulatory support products for both acute and chronic needs, advancing the company's mission of delivering superior therapies to a broad population of heart failure patients.

The acquisition of Levitronix Medical follows a successful strategic partnership between the two companies. Since 2006, Thoratec has provided distribution and clinical support in the U.S. for the CentriMag® Acute Circulatory Support System, Levitronix Medical's flagship product, under an agreement that was scheduled to expire at the end of 2011. Levitronix Medical and Thoratec have also collaborated on the development of the fully magnetically levitated motor technology employed in the HeartMate® III left ventricular assist system, which is currently in preclinical testing... Thoratec's Press Release -

Rosetta Genomics : Preliminary Data on Discovery of Blood-Based microRNA Signature for Identification and Stratification of Heart Failure Patients

07/26/11 - Rosetta Genomics (NASDAQ: ROSGD), a leading developer and provider of microRNA-based molecular diagnostic tests, announced preliminary data from a study it conducted in order to identify a microRNA signature in blood for congestive heart failure (HF) syndrome and to assess the feasibility to develop a minimally-invasive, microRNA-based stratification test for HF.

Demographic and clinical status of HF patients in combination with indices of cardiac and renal function can identify a large proportion of high risk patients, however, risk stratification based on these factors alone remains imprecise, with some high risk patients not recognized and others inappropriately marked as high risk. Early identification of patients at higher risk for adverse events could lead to earlier intervention that could potentially improve outcomes... Rosetta Genomics' Press Release -

Berlin Heart : FDA Advisory Panel Unanimously Recommends Approval of EXCOR® Pediatric Ventricular Assist Device For Use In The United States

Tuesday July 26, 2011 - At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.
The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise. It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled. Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart “Dream Team”, worked very hard to be well prepared... [PDF] Berlin Heart's Press Release -