Sales of its implantable heart pump surged during the 4th quarter and 2012 for HeartWare International (NSDQ:HTWR) after the medical device company won FDA approval for its flagship left ventricular assist device late last year.
Structural Heart
Abiomed shares open up 3% after FDA closes out warning letter
Medtronic brings MRI-friendly pacemaker to the U.S.
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.
Vatican unveils outgoing Pope Benedict’s secret pacemaker
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.
HeartWare warns on HVAD heart pumps
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.
Abiomed CEO Minogue on DoJ probe, FDA call
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.
Thoratec slips on Wall-Street-meeting Q4, 2012 earnings
Another shareholder sues Abiomed
Abiomed slides on lower Q3 profits
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.
HeartWare CEO details Q4, 2012 preliminary results
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.