December 04, 2013 | By Márcio Barra
The European medicines Agency (EMA) announced yesterday that, starting January 2014, there will be greater fee-reduction rates for orphan medicines in 2014 for big companies, something that was previously only in place for micro, small or medium-sized enterprises (SMEs).
December 02, 2013 | By Anabela Farrica
The Heartmate II Pump
Thoratec faces a big challenge as a study published in the New England Journal of Medicine shows a sharp increase in blood clots in patients implanted with its HeartMate II device, a ventricular assist device that helps patients with a failing heart.
The study examined data collected from 895 patients of 3 hospitals (Cleveland Clinic, Washington University Barnes-Jewish Hospital and Duke University Medical Center), and concluded that the rate of patients with thrombosis following the insertion of the device is raising and is associated with high morbidity and mortality. The study notes that after March 2011, the incidence of confirmed pump thrombosis within three months of implantation increased from 2.2% to 8.4% by January 2013.
The study also notes that the time between device implantation and blood clot formation is shorter than what had been previously observed.
Previous studies with HearMate II have proved the device to be effective in extending the lifespan of people with cardiac failure that are either not eligible or waiting for a heart transplant. However, the findings in this report urge investigation to address this very serious matter. While the cause of these clots remains unknown, stopping the use of this device in patients that need it is not an alternative at this point. The study authors were also unable to find any predisposing factors of causes for the increase in pump thrombosis. Since the data was collected from only three different centers, its value might be limited and an update to the risk profile of the product seems reasonable for the time being.
The New England Journal of Medicine