Category: Cardiac Assist DevicesSyndicate content

Medtronic brings MRI-friendly pacemaker to the U.S.

February 13, 2013 by MassDevice staff

Medical device giant Medtronic lands FDA approval for its MRI-friendly Advisa pacemaker system.

Medtronic logo

Medical device giant Medtronic (NYSE:MDT) won FDA approval for its Advisa DR MRI SureScan pacing system, planning to launch commercial efforts immediately.

The pacemaker's SureScan technology allows patients to receive MRI scans that normally pose a threat to traditional pacemaker function and patient safety.

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Vatican unveils outgoing Pope Benedict's secret pacemaker

February 12, 2013 by MassDevice staff

Vatican officials unveil that outgoing Pope Benedict has had a pacemaker for years and that he recently underwent a routine battery replacement.

Pope Benedict

Vatican officials revealed today that Pope Benedict has had a pacemaker for years, and recently underwent surgery to replace the implant's battery.

Vatican spokesman Rev. Federico Lombardi told reporters that the outgoing Pope had his pacemaker for "a long time" prior to being named Pope in 2005.

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HeartWare warns on HVAD heart pumps

February 8, 2013 by MassDevice staff

HeartWare tells cardiac surgeons to inspect a component of its HVAD heart pump that's failed in a small number of patients.

HeartWare International

HeartWare International (NSDQ:HTWR) said it's issuing a "field correction" to cardiac surgeons, advising them to check a component of its HVAD implanted heart pump that's been reported to fail in less than 0.004% of some 2,900 implants.

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Abiomed CEO Minogue on DoJ probe, FDA call

February 6, 2013 by MassDevice staff

A U.S. Justice Dept. investigation and the FDA's decision to require pre-market approval for Abiomed's Impella heart pump leave CEO Michael Minogue unfazed.

Abiomed

Cardiologists aren't paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.

That noise centered around a pair of events during the 4th quarter: news of a U.S. Justice Dept. probe into its marketing of the Impella pump and an FDA decision to require the device to undergo a more rigorous approval process.

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Thoratec slips on Wall-Street-meeting Q4, 2012 earnings

February 6, 2013 by MassDevice staff

Shares of Thoratec slip today after the medical device company reports earnings in line with Wall Street analysts' expectations, despite strong sales growth.

Thoratec

Investors reacted negatively to Thoratec's (NSDQ:THOR) 4th-quarter and 2012 results, despite earnings in line with Wall Street's expectations and revenues that soundly beat its forecast for the full year.

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Another shareholder sues Abiomed

February 6, 2013 by MassDevice staff

A shareholder derivative lawsuit accuses Abiomed and its management of artificially inflating its stock price by concealing allegedly improper marketing of its Impella 2.5 heart pump.

Abiomed

Another shareholder filed suit against medical device company Abiomed (NSDQ:ABMD), alleging that the heart pump maker and its management deliberately concealed allegedly illegal marketing practices for its Impella 2.5 device that led to a U.S. Justice Dept. probe.

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Abiomed slides on lower Q3 profits

February 6, 2013 by MassDevice staff

Shares of Abiomed slide 7% after the medical device company reports flat profits for its fiscal 3rd quarter, despite strong sales growth.

Abiomed

Abiomed (NSDQ:ABMD) shares dipped sharply this morning after the medical device company reported lower profits during its fiscal 3rd quarter, despite posting strong sales growth.

Danvers, Mass.-based Abiomed logged profits of $2.7 million, or 7¢ per share, on sales of $38.3 million for the 3 months ended Dec. 31, 2012, for a profit decline of 8.1% and top-line growth of 18.8% compared with the same period in 2011.