St. Jude Medicals net earnings have slipped $13 million in acquisition and restructuring charges, but 2011 second quarter sales demonstrate increases, especially in its atrial fibrillation and structural heart units.

  GAITHERSBURG, Md.—The discussion at the July 20 meeting of the FDA's Circulatory System Devices Panel, which is evaluating the Sapien transcatheter heart valve (Edwards Lifesciences) for an expected recommendation to the FDA, has been largely focused on the complication of stroke associated with transcatheter aortic valve implantations (TAVI) found in the PARTNER Cohort B trial. PARTNER investigator Michael J. Mack, MD, explained to Cardiovascular Business why the researchers did not standardize the stroke protocol differently at the trial onset.

While nesiritide (Natrecor, Johnson & Johnson) is approved by the FDA to treat dyspnea in acute heart failure (HF) patients, there is still an ongoing debate as to whether or not the human B-type natriuretic peptide is safe for the HF population. However, authors of the ASCEND-HF trial published in the July 7 issue of the New England Journal of Medicine concluded that they cannot recommend the drugs use in the majority of acute HF patients due to its association with hypotension.

CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has gained a $3.5 million equity investment in ValveXchange, a private medical device company that was spun-off out of Cleveland Clinic to develop a heart valve replacement technology platform with exchangeable bioprosthetic leaflets.

The guideline-recommended treatment is fairly well established in patients with symptomatic mitral regurgitation, but those with asymptomatic disease have a less clear strategy. Some surgeons are now advocating for earlier intervention in this population.

While it is no surprise that intense lifestyle interventions and metformin therapy can significantly reduce the development of type 2 diabetes compared with placebo, research has shown that it is also cost-effective, according to a study presented June 28 at the American Diabetes Associations (ADA) 71st annual scientific sessions in San Diego.

A global analysis has shown that the prevalence of diabetes has increased since 1980 and reached a whopping 347 million by 2008. While Harvard researchers say this boom was due to the aging population and population growth, they concluded that preventive interventions are necessary to manage and detect patients with this comordibity, according to the study published online June 25 in the Lancet.

In patients diagnosed through screening in general practice, intervention to promote early intensive management of patients with type 2 diabetes was associated with only a small, nonsignificant reduction in the incidence of cardiovascular events and death, based on the ADDITION-Europe study published June 25 in the Lancet.