October 8, 2008 – To evaluate patient safety and quality care benefits of medical devices that share data with EMRs, HIMSS Analytics and the American College of Clinical Engineering have agreed to jointly conduct an ongoing research study of medical devices in American hospitals.

October 9, 2008 – Endosense this week launched the TOCCATA (TOuCh for CATheter Ablation) clinical study to evaluate the safety of the TactiCath system for the treatment of atrial arrhythmias, with enrollment gaining momentum.

TOCCATA is a 70 patient European multi-center safety study. Constructed to gain the CE mark for the treatment of atrial arrhythmias, secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure.

October 9, 2008 - Datascope Corp. said today it will sponsor a 300-patient, randomized clinical trial in high-risk acute myocardial infarction (MI) patients who are not in cardiogenic shock to show the efficacy of intra-aortic balloon counterpulsation in reducing infarct size.

October 9, 2008 - Boston Scientific Corp. yesterday said it completed enrollment in the PERSEUS trial, designed to evaluate the company’s third-generation TAXUS Element paclitaxel-eluting coronary stent.

October 9, 2008 - Lumen Biomedical Inc. said today the FDA cleared the LBI Embolectomy System for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

October 9, 2008 - A report on initial clinical experiences with Prescient Medical’s vProtect Luminal Shield in patients with non–flow-limiting “vulnerable” plaques will be presented at TCT 2008.

Professor Patrick Serruys, director of clinical research and chief of interventional cardiology at the Erasmus Medical Center in Rotterdam, the Netherlands, will present early findings and describe the rationale and design of the SECRITT I trial, a randomized pilot study of the device in patients with vulnerable plaque.

October 8, 2008 – FDA informed healthcare professionals this week it reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) reported by Boehringer Ingelheim, which showed no increased risk of stroke with tiotropium bromide compared to placebo.

October 8, 2008 - St. Jude Medical Inc. today celebrates the 50th anniversary of the world’s first implantable pacemaker.

Oct. 8, 1958, a Swedish man named Arne Larsson received the world’s first implanted pacemaker. The groundbreaking technology for the implantable cardiac pacemaker was developed by Rune Elmqvist, M.D., of the Swedish company Elema Schönander, which eventually became part of St. Jude Medical.

October 8, 2008 - SurModics Inc. today said the PROTEX Coronary Stent System incorporating SurModics’ proprietary Finale prohealing coating technology was used in the first-in-human trial evaluating the safety of the device for the treatment of coronary artery disease.

October 8, 2008 - Ivivi Technologies Inc. said yesterday the FDA reopened the submission for an additional round of review for its SofPulse M-10, Roma and Torino II targeted pulsed electromagnetic field (tPEMF) products 510(k) submission, in response to the company’s appeal of the FDA’s earlier “not substantially equivalent” (NSE) decision.

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