Category: Cardiac Assist DevicesSyndicate content

HeartWare CEO details Q4, 2012 preliminary results

January 7, 2013 by MassDevice staff

HeartWare International CEO Doug Godshall reveals the medical device company's preliminary sales figures for the 4th quarter and 2012, saying the company expects to get 100 commercial sites online in the U.S. this year.

HeartWare International

HeartWare International (NSDQ:HTWR) posted strong double-digit sales growth during both the 4th quarter and 2012, CEO Doug Godshall told investors today at the J.P. Morgan healthcare conference in San Francisco.

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Thoratec lands FDA win for HeartMate II trial

January 7, 2013 by Arezu Sarvestani

Thoratec wins an investigational device exemption from the FDA for a clinical trial evaluating its HeartMate II ventricular system in treating patients in heart failure.

Thoratec logo

Thoratec (NSDQ:THOR) landed FDA approval to launch a new study evaluating its HeartMate II ventricular assist system in a less-sick class of patients.

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Building a whole heart for children born with half: Q+A with a cardiac surgeon

December 27, 2012 by MassDevice

Could a new surgical approach help children like Lucas get the rest of their heart back?
Could a new surgical approach help children like Lucas get the rest of their heart back?

By Tom Ulrich

CardiacAssist receives FDA IDE approval for TandemHeart pivotal trial

December 19, 2012 by MassDevice staff

The FDA gives CardiacAssist Investigational Device Exemption approval for a pivotal clinical study of the TandemHeart circulatory support system.

CardiacAssist logo

Pittsburgh-based medical device maker CardiacAssist received Investigational Device Exemption approval from the FDA to begin a pivotal clinical study of its TandemHeart circulatory support system.

The TandemHeart to Reduce Infarct Size trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients with severe heart attack, according to the press release.

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UPDATE: Did Abiomed fly too close to the sun?

December 14, 2012 by MassDevice staff

Abiomed's dilemma is of its own making, Jefferies & Co. analyst Raj Denhoy tells MassDevice.com.

Abiomed

UPDATED Dec. 14, 2012, at 10:30 a.m.

Abiomed (NSDQ:ABMD) is impaled on the prongs of a 3-horned dilemma with its flagship Impella heart pump, and it's a problem of its own making, according to 1 Wall Street analyst.

Japanese health regulators approve Thoratec 's HeartMate II pump

December 13, 2012 by MassDevice staff

Thoratec receives approval from Japan's Ministry of Health, Labor & Welfare to launch its HeartMate II, which provides a "bridge-to-transplantation therapy" for patients with advanced heart failure.

thoratec logo

Medical device maker Thoratec (NSDQ:THOR) said the company won Japan's Ministry of Health, Labor and Welfare approval for its HeartMate II, a device designed to help the heart's pumping action in patients with severe heart disease and for use in people waiting for a heart transplant.

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FDA panel decision means Abiomed will need new PMA for Impella pump

December 7, 2012 by Ingrid Mezo

An FDA advisory panel's decision to maintain Class III status on certain cardiovascular assistance devices means Abiomed and other device makers must re-apply for FDA approval.

Abiomed's Impella heart pump

An FDA panel decision will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA's more stringent premarket review pathway.

The federal watchdog agency's Circulatory Devices Advisory panel this week acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, but recommended against shifting them to a lower-risk category for temporary ventricular support. Panelists also suggested down-classification into Class II (special controls) for cardiopulmonary and circulatory bypass therapy.

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