A call for CE Mark overhaul grows at this year’s ESC conference | European Society of Cardiology Congress 2011

August 31, 2011 By MassDevice staff Leave a Comment

Physicians at this year’s European Society of Cardiology meeting in Paris called for an overhaul of Europe’s CE Mark medical device approval process, calling it too lax in review of potentially dangerous products.

Medical device makers have chided the FDA for inefficient review of new technologies and Congress has asked the watchdog agency to review Europe’s less stringent process for opportunities to revamp the system at home, but doctors had harsh criticism for the CE Mark pathway, saying it uses the same structure to review pacemakers and electric toasters.

Life-saving devices can hit the market faster in Europe where clinical testing is generally done after approval, unlike in the U.S. where high-risk devices more frequently undergo a battery of clinical trials to prove safety and effectiveness prior to being allowed on the market.

“Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval — and that tends to be Europe,” Cardiff University cardiologist Dr. Alan Fraser who led a E.U. regulatory review panel at the ESC meeting told Reuters.

Here’s a roundup of recent clinical trial and scientific study news from the ESC 2011 conference:

More ICD infections means more lead extractions for cardiologists
As more patients receive implantable cardioverter defibrillators the number of patients with infections related to their ICDs grows, a situation that is complicated by an increasingly older population with comorbidities and increased heart failure that push infection risks even higher.

Confirmed infections require complete removal of all pieces of the device, a procedure done in specialized centers.

"The extraction is a battle that requires a wonderful general, a great army, and a careful strategy," she said. "And a little bit of good luck in some situations," panel presenter Dr. Maria Grazia Bongiorni of the University Hospital of Pisa, Italy said.

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Ventricular assist devices do more harm than good for high-risk transplant patients
Patients with urgent but stable heart failure should avoid ventricular assist implants, according to data gathered from the Spanish National Heart Transplant Registry.
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Drug-eluting stents plus antiplatelet therapy make a good team for STEMI patients
Drug-eluting stents proved better than bare-metal stents in one-year clinical outcomes, including for in-stent thrombosis, target lesion revascularization, and target vessel revascularization.
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Stereotaxis touts magnetic navigation study results
Stereotaxis, Inc. (NSDQ:STXS) unveiled results from the first-ever, prospective multicenter evaluation of magnetic navigation for ventricular tissue ablation with a 94 percent acute success rate.
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Qosina buys Alpha Industries
Qosina announced that it has acquired Alpha Industries (Clearwater, Fla.). The financial details of the deal were not disclosed. Alpha Industries’ adds its plastic forceps, clamps and bowls as an extension to Qosina’s current OEM components offerings. “With this acquisition, Qosina continues to expand its product line, which reinforces its position as a global leader […]
Avalign Technologies acquires Thortex and Millennium Surgical
Avalign Technologies announced that is has acquired Thortex and Millennium Surgical. The financial details of the deal were not disclosed. Thortex provides precision manufacturing, porous coatings and metal injection solutions to the medical device market. It has porous coating solutions for titanium and cobalt-chrome orthopedic implants and manufacturing and engineering technologies for medical device OEMs. […]
FDA unveils new policy for accepting medical device consensus standards
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have disclosed a new process for evaluating and accepting voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
Could this algorithm be better at diagnosing arrhythmia than cardiologists?
A new algorithm that can go through hours of heart data to detect arrhythmia performs better than trained cardiologists, according to new research from Stanford University. The algorithm gathers data from wearable monitors to find life-threatening irregular heartbeats and allows for data to be sorted through in remote areas where there is a scarcity of […]
How a single drop of blood can detect sepsis
Sepsis can be identified by a single drop of blood, thanks to a lab-on-a-chip device from the University of Illinois. Researchers at the University of Illinois and the Carle Foundation Hospital in Urbana, Ill., recently completed a clinical study of the device that provides a fast, point-of-care measurement of the body’s immune system response without […]
Wearable device gives real-time posture feedback to Parkinson’s patients
University of Houston researchers have developed a smartphone-based biofeedback rehabilitation system – a wearable device designed to help people with Parkinson’s disease. The research team developed the Smarter Balance System (SBS) to help guide patients through balance exercises while using wearable technology. It is designed to help people regain stable balance and confidence in doing […]
How the IDSA Patient Safety Task Force wants to tackle U.S. medical errors
The IDSA Patient Safety Task Force has given itself a critical mission to solve the “medical error crisis” in the United States. The task force proposes to engage in strategic problem solving through creative system design, UX and the visual communication skills of industrial designers. Sean Hägen – who chairs the task force and IDSA’s Medical Special Interest […]
Tegra Medical announces new general manager
Tegra Medical announced that it has appointed John Rieth as general manager of its Franklin, Mass. location. Rieth will report to the president and CEO of Tegra, J. Mark King, and will be in charge of its local management team and plant operations. Rieth recently served as director of operations at Pharmasol Corporation, operations/engineering manager […]
Building a strong FDA workforce to bring scientific advances to patients
Dr. Scott Gottlieb The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce. Our staff must remain […]
Could this temperature sensor reduce power consumption in medical devices?
A new temperature sensor that runs at 113 pW could make wearables and even implantable medical devices less power dependent, according to research from the University of California at San Diego. The temperature sensor, developed by electrical engineers at UCSD, uses about 628 times lower power than state-of-the-art power sources and is 10 billion times […]
How MRI can power mini-robots inside the body for targeted treatment
Scientists at the University of Houston and Houston Methodist Hospital are harnessing the power of magnetic resonance imaging (MRI) to drive mini-robots through the body for targeted treatment. The researchers are developing control algorithms, imaging technology, ultrafast computational methods and human-machine immersion methods that could enable the steering of dozens or even thousands of tiny millimeter-sized […]