HeartWare International (NSDQ:HTWR) completed enrollment in a 450-patient pivotal trial considering its ventricular assist system as a destination therapy for patients with advanced heart failure.
Structural Heart
Thoratec kills it in Q1, Wall Street shrugs | Earnings Roundup
Thoratec (NSDQ:THOR) started today up 7.2% as investors reacted to its stellar 1st-quarter numbers, but by the time the market closed THOR shares had fallen back to Earth to close at $34.46, down 0.1%.
The heart pump maker posted profits of $25.5 million, or 43¢ per diluted share, on sales of $126.8 million for the 3 months ended March 31.
Thoratec kills it in Q1, Wall Street shrugs
Thoratec (NSDQ:THOR) started today up 7.2% as investors reacted to its stellar 1st-quarter numbers, but by the time the market closed THOR shares had fallen back to Earth to close at $34.46, down 0.1%.
The heart pump maker posted profits of $25.5 million, or 43¢ per diluted share, on sales of $126.8 million for the 3 months ended March 31.
HeartWare wins FDA panel nod
An FDA advisory panel recommended approval for HeartWare International‘s (NSDQ:HTWR) HVAD implantable heart pump for people with end-stage heart failure.
The watchdog agency’s circulatory devices panel said the agency should approve the left ventricular assist device for use as a so-called "bridge to transplant" for patients waiting for a heart transplant.
NASDAQ halts trading in HeartWare shares ahead of FDA panel vote
Early indications that the FDA is likely to approve an implantable heart pump made by HeartWare International (NSDQ:HTWR) pushed its shares up nearly 7% this week, prompting the NASDAQ stock exchange to halt trading of the shares today as an agency panel considers the company’s pre-market approval application.
Abbott, St. Jude Medical re-up ‘cardiovascular alliance’ | Wall Street Beat
MassDevice.com +3 | The top 3 med-tech stories for April 12, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Abiomed lands CE Mark for Impella cVAD
Less than 2 weeks after touting first-in-man use of its catheter-based Impella cVAD heart pump, Abiomed (NSDQ:ABMD) won CE Mark approval to launch the device in the European Union.
EuroZone regulators cleared the device for up to 5 days of pumping support for patients with a number of heart conditions, as well as for support during coronary bypass surgery or during or after percutaneous coronary intervention.
Thoratec’s HeartMate II correction dubbed a Class I recall
Thoratec’s (NSDQ:THOR) voluntary "correction" for the HeartMate II heart pump was slapped with Class I recall status from the FDA on concerns that an improperly connected component may result in deformation or tearing of the device’s outflow conduit.