HeartWare International Inc. president and CEO Doug Godshall was upbeat in a letter to shareholders accompanying a securities filing, writing that the company is on sound footing despite a move by the U.S. Federal Trade Commission to block its proposed acquisition by Thoratec Corp.
Saying it believes the merger “would substantially reduce competition in the U.S. market for left ventricular devices,” the commission alleged that Thoratec already enjoys a monopoly on the sale of LVADs in the U.S. and would only increase its hegemony if the merger is consummated.
Strong sales of a catheter-based cardiac assist device helped Abiomed Inc. narrow its losses by nearly 25 percent for fiscal 2009.
Sales rose 12 percent to $19.6 million during the fourth quarter of 2009, compared with $17.5 million for the same period last year, according to a filing with the federal Securities and Exchange Commission. Net losses narrowed to $8.5 million on the quarter, compared with $15 million for the same period during fiscal 2008.
Full-year sales were $72.5 million, a 24 percent jump compared to $58.3 million during fiscal 2008. Net losses narrowed to $31.6 million, compared to $41 million for the prior year.
Ninety percent of patients in the first human trial of HeartWare International Inc.‘s left ventricular assist implantable pump survived at least 180 days.
The clinical trial involved 50 patients in the United Kingdom, Austria, Germany and Australia who were implanted with the Framingham-based heart pump maker’s device, designed to enable heart transplant candidates to survive until transplatation.
Abiomed Inc.‘s latest heart pump models got the nod to hit the market from the federal Food & Drug Administration.
The federal watchdog agency granted 510(k) approval for the Danvers-based heart pump maker’s Impella 5.0 and Impella LD devices.
That means the minimally-invasive catheter-based pumps are cleared to provide circulatory support for up to six hours, easing the burden on patients’ hearts during serious cardiac events.
The federal Food & Drug Administration granted pre-market approval to Abiomed Inc.‘s AB Portable driver, clearing the way for the Danvers-based cardiac device maker to bring the portable support console component to market.
The device is designed to power Abiomed‘s AB5000 circulatory support system, which provides temporary support for one or both sides of the heart when the heart has failed but could recover, according to the company’s website.
Zoll Medical Corp. agreed to buy out Alsius Corp. for $12 million, adding the Irvine, Calif.-based intravascular temperature management product maker’s operations to its line of cardiac resuscitation devices.
Chelmsford, mass. based Zoll said it will integrate the Alsius business into its operations in Sunnyvale, Calif.