CoreValve®: High Risk Patient Study Enrollment Complete, FDA Says Yes To Start Intermediate Risk Patient Study

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.

St. Jude “Restructures” 300 Jobs Away, And Reshuffles Execs In Future-Proofing Move

St.Jude has taken the radical decision to shoe-horn its previous four divisions into two. These will be called the Implantable Electronic Systems Division (IESD), which will encompass CRM and Neuromodulation, and the Cardiovascular and Ablation Technologies Division (CATD), which will encompass Atrial Fibrillation and Cardiovascular. 300 job cuts and a host of efficiency savings are anticipated.

Results Of IABP Study In Cardiogenic Shock Patients Only Hint At Benefit

Maquet Cardiovascular has issued a press release pointing us to the publication at ESC of clinical data which says its intra-aortic counterpulsating balloon shows observable 30 day reduction in mortality. The study size dictated that a 12% reduction was required in order to demonstrate significance, a target which was not reached.

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