I repeatedly hear two competing, contradictory themes discussed at every symposia – the need to lower healthcare costs and that costs to bring new technology to market are rapidly increasing. The U.S. leadership position as a medical technological innovator is slipping to Europe, where there is a much wider selection of devices to choose from. The requirements to gain CE mark clearance are much more lenient than U.S. Food and Drug Administration (FDA) pre-market approval.  

I repeatedly hear two competing, contradictory themes discussed at every symposia – the need to lower healthcare costs and that costs to bring new technology to market are rapidly increasing. The U.S. leadership position as a medical technological innovator is slipping to Europe, where there is a much wider selection of devices to choose from. The requirements to gain CE mark clearance are much more lenient than U.S. Food and Drug Administration (FDA) pre-market approval.



New developments in drug-eluting stents, such as biodegradable materials and bifurcated stents, are expected to prompt an increase in market value. Companies like Biosensors and Abbott are developing biodegradable and bifurcated stents to deal with concerns about thrombosis caused by long-term device implantation and to expand the type of treatable lesions, including those located at vessel branches.


The space needed and costs involved to create a hybrid operating room (OR) for a specific speciality may not be feasible, especially at mid-sized hospitals. This was the case at Middlesex Hospital in Middletown, Conn., where the facility wanted to increase procedural volume, but needed to upgrade its small operating rooms for vascular, endovascular, laparoscopic and endoscopic procedures.



One of the biggest trends is the creation of hybrid operating rooms (ORs) that bring together the best of both surgical and interventional technologies. They are centered around a high-quality angiographic X-ray imaging system, allowing new collaborative treatment strategies and new types of procedures. Users say the shift to hybrid ORs is more than a change of venue for procedures, it is a paradigm shift in medicine.


September 20, 2011 — Maquet Cardiovascular announced it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Sensation Plus 50 cc 8 French intra-aortic balloon (IAB) catheter. The device also received CE mark approval from the British Standards Institution (BSI).

September 20, 2011 — A new study published in the Sept. 27 issue of the Journal of the American College of Cardiology reveals heart failure (HF) patients with Medicaid, Medicare or no insurance have longer hospital stays than those with private/HMO insurance. The under-insured are less likely to receive some of the recommended, evidence-based therapies for HF; they are also 22 percent more likely to die in-hospital.

September 20, 2011 — Toshiba America Medical Systems Inc. will highlight its Aquilion One computed tomography (CT) system at the American Society of Emergency Radiology (ASER) conference, Sept. 14-17, 2011 in Miami. The company will specifically showcase the system’s application in an emergency department (ED) setting.

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