The Medicines Company has announced that its financial results for the 2010 fourth quarter and full year, which ended Dec. 31, 2010, were positively impacted by sales of bivalirudin (Angiomax)particularly international salesallowing the company to pull out of net losses.

Spectranetics has reported a flat net loss for its financial results for the 2010 fiscal year, which ended Dec. 31, 2010, and net income gains in the 2010 fourth quarter, compared with the 2009 fourth quarter.

Acquired thrombocytopenia occurs in approximately one in 14 patients with acute coronary syndromes (ACS) treated with anti-thrombin and antiplatelet medications and is strongly associated with hemorrhagic and ischemic complications, according to a post hoc analysis of the ACUITY trial. The study, published in the February issue of the American Heart Journal, also found that the administration of bivalirudin monotherapy appears to be associated with less frequent declines in platelet count, compared with an anticoagulant regimen including a GP IIb/IIIa inhibitor.

A Georgia Tech and Emory University medical device startup, Apica Cardiovascular, which has developed a system to standardize transapical access and closure procedures of the beating heart during cardiac surgery, has received a $5.1 million investment.

Acute elevated levels of myocardial necrosis biomarkers following CABG surgery, no matter how incrementally small, are prognostic for death, even out to five years, which has implications for clinical trial design, according to a study in the Feb. 9 issue of the Journal of the American Medical Association.

During a recent meeting in January in France, in which regulators and physicians from the U.S. and the European Union (EU) met to discuss ways to improve the EU medical device approval process, it was determined that it would be better to see one regulatory body for the entire EU, rather than separate approval bodies for each country. The attendees also are seeking more experts specific to the device in question involved in the approval process.

Merck has posted its financial returns for the 2010 fourth quarter and the fiscal year 2010, recording a net drop in net income, partly due to charges related to its struggling antiplatelet drug vorapaxar.

Edwards Lifesciences, which develops heart valves and hemodynamic monitoring, has reported a decrease in its net income for the 2010 fiscal year, which ended Dec. 31, 2010, despite posting increases in net sales and income during the fourth quarter of 2010, compared with the previous year's last quarter.