November 1, 2012 — Terumo Interventional Systems announced the nationwide availability of its new Pinnacle Precision Access System, a new vascular access system specifically designed for smooth, efficient and reliable peripheral vascular access.


November 1, 2012 — InspireMD Inc. announced that its proprietary MGuard embolic protection stent (EPS) was shown to be significantly superior when compared to standard bare metal and drug-eluting stents in achieving complete ST resolution and restoring normal blood flow in a major study of 432 randomized patients undergoing emergency coronary intervention for potentially fatal heart attacks.

October 31, 2012 — Boston Scientific Corp. received CE mark approval for the Synergy everolimus-eluting platinum chromium (PtCr) coronary stent system featuring an ultra-thin abluminal (outer) bioabsorbable polymer coating.
Breast Cancer Radiation Therapy Clinical Trial/Study

Breast cancer patients who receive radiation treatment do not have a higher risk of long-term cardiac morbidity when compared to patients undergoing modified radical mastectomy (MRM), according to research presented at the American Society for Radiation Oncology’s (ASTRO’s) 54th Annual Meeting. This is the first study to document comprehensive, late cardiac outcomes 25 years after breast cancer treatment.

Maquet Cardiovascular received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new Sensation Plus 7.5 French 40 cc intra-aortic balloon (IAB) catheter. This new larger-volume, fiber-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy “at the speed of light” to smaller patients.

W. L. Gore & Associates (Gore) responded to initial results reported in St. Jude Medical Inc.’s RESPECT clinical trial. The RESPECT study investigated whether transcatheter closure of patent foramen ovale (PFO) using St. Jude’s Amplatzer PFO Occluder device is safe and effective compared to best medical therapy in the prevention of recurrent cryptogenic stroke. Gore is concurrently conducting its Gore REDUCE Clinical Study using both the Gore Helex Septal Occluder and, as reported earlier this week, the new Gore Septal Occluder, in patients with PFO and a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA).

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