Jan. 25, 2007 — ev3 Inc. has announced FDA approval of the PROTÉGÉ RX Carotid Stent, which, when used in conjunction with ev3’s SpideRX Embolic Protection Device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery.

Jan. 25, 2007 — Research emerging this week from a Harvard researcher claims there is no evidence that statins prevent heart disease in women. In addition, data suggest that men over 69 with only moderate risk of future heart problems are not benefited by taking statins either.

The drugs should no longer be regularly prescribed to these populations, according to the finding from Dr. John Abramson, Harvard Medical School, and Dr. James M. Wright, from the University of British Columbia.

Jan. 25, 2007 — Abiomed, Inc. has announced the development of a pediatric circulatory support technology. Currently in pre-clinical studies, Abiomed has developed a catheter-based heart pump, similar to the Impella LP2.5, that provides left-ventricular support to small pediatric patients requiring preconditioning prior to a cardiac intervention, or to recover patients who are either post-surgery, cannot be weaned from bypass, or who have endocarditis.

Jan. 23, 2007 — The FDA has granted 510(k) clearance for FlowCardia’s CROSSER 14 CTO Recannalization System, an endovascular catheter designed to help place standard guide wires beyond chronic total occlusions in coronary arteries.

Deployed during a minimally invasive procedure in the cath lab, the CROSSER uses high-frequency vibration to advance a guide wire across CTOs, enabling balloon angioplasty and stent placement and thus averting CABG surgery for many patients.

Jan. 23, 2007 — Vascular Solutions announced it has received 510(k) clearance from the FDA to begin marketing its new 023 version of the Twin-Pass dual access catheter, and the company says it plans to launch the device immediately through its direct U.S. sales force.

Expanding on the original two-lumen catheter launched last January, the new version offers a larger, 0.023-inch lumen diameter that allows the Twin-Pass 023 catheter to measure intra-arterial pressures and deliver specialty guide wires into the distal vasculature.

Jan. 23, 2007 — A comprehensive, large-scale computer simulation of cholesterol regulation, atherogenesis, and cardiovascular risk has been created by Entelos Inc, a life sciences company that builds predictive computer models of human physiology and "virtual patients" for drug discovery and development

The Cardiovascular PhysioLab platform enables Entelos to rapidly assess novel drug targets, evaluate combination therapies, identify and interpret biomarker patterns, and predict a drug's long-term clinical efficacy in managing cholesterol, atherosclerosis and heart disease.

Jan. 23, 2007 — Carotid stent maker ev3 will sponsor an evening symposium at the International Symposium of Endovascular Therapy Monday, Jan. 29 at the Westin Diplomat Regency, Hollywood, FL. Titled “CSI: Carotid Stenting Innovations” and themed after the CSI television show, the program will offer a forum for dialog on trends and tools in carotid stenting and embolic protection.

Jan. 18, 2007 - “Do I really need to fill out that form again? Isn’t there a way I can just answer the few questions that are different?”

This is one of the most common complaints Michael Zaroukian, M.D., hears from his patients — at least when he’s wearing his ‘primary care physician’ hat.

Jan. 19, 2007 — Biosense Webster made two agreements public this week with healthcare competitor modality giants Philips and Siemens.

Jan. 19, 2007 — Daiichi Sankyo Co., Ltd. and Eli Lilly and Co. have announced completion of patient enrollment in their pivotal Phase III head-to-head clinical study — TRITON TIMI-38 — to evaluate the safety and efficacy of prasugrel compared with clopidogrel (Plavix) in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).

Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Medical Center is the study’s lead investigator and senior investigator in the TIMI Study Group.

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