Category: Thoratec Corp.
Here's a look at some of the top regulatory stories for medical device companies this week: Covidien taps integration chief to navigate Medtronic merger; Zimmer, Biomet appoint integration team; Thoratec inks $75M deal for Apica Cardiovascular; FTC wants more from Zimmer, Biomet on merger; Johnson & Johnson closes Ortho-Clinical Diagnostics sale
Thoratec pays $35 million up front and puts another $40 million up in milestone payments for Apica Cardiovascular and its transapical access technology.
Thoratec (NSDQ:THOR) said it paid $35 million up front and agreed to another $40 million in potential milestone payments for Apica Cardiovascular and its transapical access technology.
Thoratec says it's launched a clinical trial for its HeartMate III implantable heart pump it plans to useto back a bid for CE Mark approval in the European Union.
A New England Journal of Medicine report on higher-than-expected blood clot rates for Thoratec's HeartMate II implantable heart pump took market share during the 1st quarter, company officials said today.
A New England Journal of Medicine report last year detailing sharp increases in the rate of blood clots helped take market share away from Thoratec (NSDQ:THOR) and its HeartMate II implantable heart pump, company officials said yesterday.
ReliantHeart touts study data finding that its HeartAssist5 left ventricular assist device poses a lower risk of blood clots and damage compared with Thoratec's HeartMate II.
FDA regulators put their highest-risk Class I label on a recall of Thoratec's HeartMate II implantable heart pump after 5 patients injuries and 4 deaths were reportedly associated with a defect in controlling the implants.
MASSDEVICE ON CALL — The FDA issued it's highest-risk Class I warning after Thoratec (NSDQ:THOR) recalled its HeartMate II implantable heart pumps over a controller issue that the FDA said was associated 4 patient deaths and 5 serious injuries.
Thoratec updates its warning about the risk of switching controllers for its HeartMate II implantable heart pump.
Thoratec (NSDQ:THOR) issued an update about a problem with its HeartMate II left ventricular assist device involved in 8 serious injuries or deaths.