Impella Circulatory Support Device No Benefits in Cardiogenic Shock

New results from a prospective, randomized, multi-center trial of the Impella CP heart pump (Abiomed) versus intra-aortic balloon (IAB) counterpulsation in patients with cardiogenic shock demonstrated no improvement in mortality with the Impella CP device and significantly more bleeding and hemolysis complications. The data were recently presented at the 28th Annual Transcatheter Cardiovascular Therapeutics (TCT) … Continue reading Impella Circulatory Support Device No Benefits in Cardiogenic Shock

ST. JUDE & ABBOTT to sell portion of vascular closure and electrophysiology business to TERUMO

ABBOTT’S ACQUISITION OF ST. JUDE MEDICAL IS EXPECTED TO CLOSE BY YEAR-END THE AGREEMENT IS AN IMPORTANT STEP TOWARD COMPLETION OF ABBOTT’S ACQUISITION OF ST. JUDE MEDICAL Abbott (NYSE: ABT) and St. Jude Medical, Inc. (NYSE: STJ) announced today an agreement in principle to sell certain products to Terumo Corporation. The transaction reflects a purchase … Continue reading ST. JUDE & ABBOTT to sell portion of vascular closure and electrophysiology business to TERUMO

Jarvik Heart Receives FDA Approval for Clinical Trial of Miniature Heart Assist Device for Infants and Children

The U.S. Food and Drug Administration has granted conditional approval to conduct an Investigational Device Exemption study of Jarvik Heart’s new miniature Left Ventricular Assist Device (LVAD) System. The study will compare the implanted, portable electrically-powered Jarvik 15mm LVAD System with the Berlin Heart EXCOR Pediatric System. Jarvik Heart, Inc. is the manufacturer of the … Continue reading Jarvik Heart Receives FDA Approval for Clinical Trial of Miniature Heart Assist Device for Infants and Children

Abiomed: Approval received for Japan approval for its Impella 2.5 and Impella 5.0 heart pumps.

The approved devices are cannulas blood pumps, designed for acute heart failure (cardiogenic shock). Abiomed is opening a larger office in Tokyo, recruiting for clinical support staff, and submitting for Japanese reimbursement in the near future. A rigorous on-site training and certification program is planned including physician proctoring. Abiomed plans to start supporting patients in … Continue reading Abiomed: Approval received for Japan approval for its Impella 2.5 and Impella 5.0 heart pumps.

Intra-Aortic Circulatory Support Pump with Aortix Minimally Invasive technic

Over 6 million people are affected by Heart failure in the US alone. Every year, 660,000 new cases are diagnosed and more than 1 million hospitalizations occur, with a cost approaching $35 billion. For 2 million of these patients (US), drugs can no longer control the problem and, in most cases, the only options remaining … Continue reading Intra-Aortic Circulatory Support Pump with Aortix Minimally Invasive technic

Atrium Medical Corp. from Getinge Group agrees to $11.5 million settlement

Medical device manufacturer accused of improper kickbacks to doctors Hudson-based Atrium Medical Corp. has agreed to an $11.5 million settlement with former sales representative and whistle blower Esther Grace Sullivan over claims it paid improper kickbacks to doctors for promoting the unapproved use of medical stents in patients’ arteries. Grace, who also worked as a … Continue reading Atrium Medical Corp. from Getinge Group agrees to $11.5 million settlement

Coronary Stents with a maximum retail price to be announce

The general public can expect the government to announce within three months, the maximum retail price for coronary stents, which has recently been added to the national list of essential medicines (NLEM) 2015, effectively bringing them under price control. While patients, doctors and Indian-stent manufactures have welcomed the move, others aren’t celebrating the announcement. Recommendations … Continue reading Coronary Stents with a maximum retail price to be announce

ECMO Market (Extracorporeal membrane oxygenation) systems: Industry and future trends analysis

The global ECMO market accounted for USD 227.7 million in 2014 and is expected to reach USD 287.6 million by 2020 at a CAGR of 4.0% from 2015 to 2020. The purpose of the report published recently is to cover the definition, description, and forecast of Global Extracorporeal Membrane Oxygenation (ECMO) System market. It involves … Continue reading ECMO Market (Extracorporeal membrane oxygenation) systems: Industry and future trends analysis

Save More Than $8,000 Per Patient Annually are Geneia’s Study Findings thanks to Remote Patient Monitoring Could

The results of a year-long remote patient monitoring pilot from Geneia LLC (Geneia), an analytics and technology leader in transforming healthcare delivery, yielded a savings of $8,375 per monitored patient annually, which, for a typical one-million-member health plan could translate into about $1.1 million saved each year. A remote patient monitoring pilot reported average annual … Continue reading Save More Than $8,000 Per Patient Annually are Geneia’s Study Findings thanks to Remote Patient Monitoring Could