Feature | Dan Edwards

Medical device companies spend around $1 million at the front end of every device development project to get to a product concept that they want to take to market. Some vendors spend it better than others, according to Sagentia, a company that works with device vendors to develop new technologies, products and services.

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March 11, 2011 – DR Systems will exhibit its Unity Cardiovascular Information System (CVIS) at next month’s American College of Cardiology (ACC) meeting. The system provides a cost effective, comprehensive cardiology solution for institutions that need a new cardiology system whether replacing aging, limited systems or moving from tape to a digital solution.

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March 11, 2011 – U.S. Food and Drug Administration (FDA) and Lantheus Medical Imaging Inc. today reached agreement on a phase 3 clinical trial design to assess myocardial perfusion using flurpiridaz F18 positron emission tomography (PET) imaging in patients with suspected or known coronary artery disease (CAD).

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March 11, 2011 – Sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, has another possible use – helping children and young adults with congenital heart disease to better tolerate exercise.

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March 11, 2011 – Texas Children's has become the world's first pediatric hospital to complete the first phase of certification to implant the SynCardia temporary Total Artificial Heart. The hospital intends to use the device as a bridge to transplant for their patients who received a heart transplant as children and now require mechanical support as a bridge to their second transplant.

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March 11, 2011 – The U.S. Food and Drug Administration (FDA) has approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brain. This should help patients at greater risk of stroke during standard bypass surgery.

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March 10, 2011 – The U.S. Food and Drug Administration (FDA) has granted an abbreviated new drug application (ANDA) for a fludeoxyglucose (FDG) F18 injection. Siemens PETNet Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for F18 FDG.

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March 10, 2011 – The first study to compare pain associated with deployment of different vascular closure devices (VCD) as the primary endpoint has been published in the Journal of NeuroInterventional Surgery. The trial compared the discomfort associated with the Mynx 5 French VCD, from AccessClosure, to the Angio-Seal Evolution Device.

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March 10, 2011 – New guidelines have been published in The Annals of Thoracic Surgery that include point-of-care testing for platelet reactivity as a new recommendation for preoperative patient assessment.

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March 10, 2011 – Five Methodist Healthcare facilities in San Antonio, Texas, are now using a chest pain management solution to make pre-hospital and emergent electrocardiographs (ECGs) immediately available to cardiologists. The HealthView Chest Pain Management system, from Lumedx, also allows cardiologists to interpret, review and immediately compare them with previous ECGs.

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March 10, 2011 – A newly introduced catheter provides a superior answer for percutaneous fluid aspirations and small volume drainage procedures. The Drainer centesis catheter, from Vascular Solutions features large sideholes designed to prevent clogging and provide faster, more reliable drainage.

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March 8, 2011 – A new endoscopic vessel harvesting (EVH) has been launched in the United States. The Vasoview 6 Pro, by Maquet Cardiovascular, offers streamlined controls, improved functionality and simplified operation to support positive outcomes in patients undergoing coronary artery bypass graft (CABG) surgery.

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Physio-Control has acquired Swedish-based Jolife AB, the developer and manufacturer the automated Lucas Chest Compression System. Prior to the acquisition, Physio-Control had been the exclusive distribution partner for the Lucas device since 2004. The terms of the agreement are not being disclosed.

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Circadian rhythms affect the incidence of coronary stent thrombosis, with more events occurring during the early morning hours, according to new research published in the February 2011 issue of JACC: Cardiovascular Interventions.

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March 8, 2011 – The expansion of a cloud computing system has been announced at the European Congress of Radiology (ECR) in Vienna. TeraRecon is opening a European datacenter for its iNtuition Cloud. This European node will be automatically selected when users access their iNtuition Cloud account from a location closer, in network terms, to the new datacenter, ensuring optimal performance.

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