Category: Congestive Heart Failure Devices

FDA approves Thoratec's HeartMate II as a "destination therapy"

January 20, 2010 by MassDevice staff

The U.S. Food & Drug Administration expanded its clearance of Thoratec Corp.'s (NSDQ:THOR) HeartMate II left ventricular assist device for implantation into patients who can't receive heart transplants.

The federal watchdog agency had previously cleared the device, which helps the heart's pumping action in patients with severe heart disease, for use in people waiting for a heart transplant. The expansion means the device can be used as a so-called "destination therapy," implanted indefinitely in people who aren't eligible for a new heart.

HeartWare files for destination therapy IDE

November 23, 2009 by MassDevice staff

HeartWare International Inc. (NASDAQ:HTWR) took another step in its chase after one-time suitor and main competitor Thoratec Corp. (NSDQ:THOR), filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren't eligible for a heart transplant.

The Framingham, Mass.-based device maker's left ventricular assist device is already cleared for use as a bridge to heart transplant. The new application seeks an IDE for use of the device as a "destination therapy," in effect a permanent implant patients would carry until death.

Abiomed posts strong Q4, fiscal 2009 sales

May 12, 2009 by MassDevice staff

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.

HeartWare: 90% of LVAD-implanted patients live at least 6 months

April 27, 2009 by MassDevice staff

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 wins 510(k) clearance from FDA for Impella 5.0 and Impella LD heart pumps

April 23, 2009 by MassDevice staff

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.

FDA OKs component of Abiomed's portable heart support system

March 30, 2009 by MassDevice staff

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.