St. Jude Medical has launched a portable version in Europe and Japan of its system to offer physicians a view from within the heart to enable physicians to make decisions during catheter-based stenting procedures. Dubbed Optis Mobile, the system is expected to offer comparable imaging as compared to the company's already marketed Optis Integrated System.
The FDA just released a draft list of devices whose applications for marketing approval should include human factors data to ensure usability is considered during the design and regulatory process. It also finalized a guidance from 2000, providing updated information on the methods by which companies should collect and submit human factors data.
Thoratec said that two patients died and one suffered a serious injury after they were unable to connect their HeartMate II left ventricular assist device to their backup system controller in a timely manner.
The 30-day "go-shop" period for LVAD maker Thoratec is over. No other bids to acquire the company were made. That means Thoratec is likely to become part of St. Jude Medical in the Q4, when the bigwig's $3.4 billion acquisition is expected to close.
The FDA issued a public warning about the risks of left ventricular assist devices used to pump the blood of patients with end-stage heart failure, including strokes, the formation of blood clots inside the pump and bleeding complications.
The consensus is that none of the other medical device bigwigs will try and steal heart pump maker Thoratec from the clutches of St. Jude Medical during the $3.4 billion deal's 30-day "go-shop" period.
UPDATED: St. Jude to buy Thoratec for $3.4B, will pair its heart pump with the cardioMEMs patient monitor
St. Jude Medical announced its intention to acquire Thoratec, the maker of ventricular assist devices that pump the blood of patients awaiting a heart transplant, for $3.4 billion. Its stock price is up 2.5% on the news.
Industry bigwig St. Jude Medical is discussing a buyout of specialist Thoratec, a maker of left ventricular assist devices, which give heart failure patients awaiting a donated heart a bridge to organ transplantation by pumping their blood in the meantime. Thoratec stock is up 18% to around $58 on the rumor, as of 3 p.m.
Thoratec received a CE mark for its HeartMate Percutaneous Heart Pump, following a 30-person clinical trial.
Thoratec touted clinical trial data presented at an International Society for Heart and Lung Transplantation meeting in Nice, France, showing that advanced heart failure patients who receive ambulatory--or outpatient--care are better off using its HeartMate II left ventricular assist device than receiving optimal medical management.