AGA Medical gets IDE authorization to evaluate AMPLATZER Cardiac Plug AGA Medical Holdings.


Approval of the study will now allow us to help expand evaluate our method of reducing strokes in patients with atrial fibrillation through the use of our AMPLATZER Cardiac Plug to completely seal the appendage, ideally sparing individuals from spending the others of their lives on anticoagulants. The study design is founded on a statistical method known as a Bayesian adaptive style with interim analyses that use observed efficacy and basic safety event price data to predict the final sample size, probabilities for trial achievement and when the trial ought to be stopped. Interim analyses will end up being performed following the first 400 sufferers are enrolled and at pre-identified periodic intervals thereafter, until a possible maximum of 2,000 individuals are enrolled.Vaccination strategies that successfully stimulate antitumor immune responses in both more youthful and older sufferers are dependent on combining different therapies. The therapies must keep the balance between activating a safe and effective antitumor immune response and inducing an autoimmune reaction. Dr Lustgarten concludes: ‘The disease fighting capability of the elderly is very different from the young and it is tough to extrapolate results obtained in the young, for use in the old.