| News for medical technology professionals | September 28, 2012 |
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| AdvaMed SmartBrief Special Report: Clinical trials |
| Clinical trials are the key to ensuring that medical devices and treatments that show promise in the lab fulfill that promise with patients. Med tech companies follow rigorous standards to ensure trials provide accurate assessments of their devices. Industry groups are working with the FDA to streamline the regulatory process to shorten the time between invention and commercialization, and ease the financial burden. This AdvaMed SmartBrief Special Report looks at some medical devices in clinical trials, as well as regulatory changes that affect devices nationally and internationally. It also highlights some sessions of interest at AdvaMed 2012, taking place Oct. 1-3. |
| The Clinical Trial Pipeline |  |  |
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- Codman's aneurysm device has positive trial results
A study in Neurosurgery indicated that 81% of patients with wide-neck saccular aneurysms showed at least 90% aneurysm closure 21 months after being treated with Codman & Shutleff's Vascular Reconstruction Device. The study also found that only 8.3% of patients needed retreatment after receiving the self-expanding stent. Mass High Tech (Boston)
(9/17)      
- Dune's device shows promise in prostate cancer trial
Dune Medical Devices said its MarginProbe device has been shown in a prostate cancer study to have the ability to distinguish between healthy tissue and tumors with "a very high degree of accuracy." The company is awaiting FDA approval for use of the device in breast cancer detection, which it hopes will come by year's end. Mass High Tech (Boston)
(9/17)
- SPR gets FDA OK to test pain relief device in stroke patients
The FDA has cleared SPR Therapeutics to launch a pivotal trial to test whether its Smartpatch Peripheral Nerve Stimulation System is safe and effective in treating shoulder pain in stroke patients. About 60 patients will be enrolled in the randomized, placebo-controlled trial, which will kick off by year's end. MedCityNews.com
(9/20)
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| | Harvard Clinical Research Institute offers research sponsors operational efficiency and scientific excellence by connecting academia to industry.
HCRI-affiliated academic physicians provide insight into the impact, safety, and practicality of emerging products. | |
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| Regulatory Affairs and Compliance | | |
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- EU publishes proposals for tightened medtech oversight
New regulations for medical devices and in vitro diagnostics have been published by the European Commission. While the commission did not call for premarket approval similar to the U.S. FDA's, it did approve a "scrutiny mechanism" that allows authorities to re-examine medical devices and give their input before those devices go on the market. The new proposals also allow for companies to conduct clinical trials in multiple EU member states but make only a single application through a yet-to-be-established electronic system. Clinica (subscription required)
(9/26)
- Workshop helps China adopt latest medtech standards
The U.S.-China Joint Commission on Commerce and Trade recently held a two-day workshop to assist China's State Food and Drug Administration in implementing the third edition of IEC 60601-1, the globally recognized electrical medical equipment safety standard. AdvaMed helped lead the event, which brought in speakers from North and South America, Asia and Europe. Clinica (subscription required)
(9/21)
- FDA outlines post-market device monitoring plan
The FDA has issued a report detailing its proposals to strengthen the agency's efforts to track the safety and effectiveness of medical technologies. Comments on the four-pronged plan, which includes creating a unique system to identify devices and integrating them into electronic health records, can be submitted on the agency's website. Healthcare Finance News
(9/7)
 | Harvard Clinical Research Institute advances the research of pharmaceutical, biological and medical device products by developing collaborations between industry and academia. HCRI offers industry sponsors access to valuable scientific leadership, focused operational research functionality and analysis of high quality clinical trial data.
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| SmartPulse | | |
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What is the top concern of research sponsors today?
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Cost |
39.47%
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Regulatory |
31.58%
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Financing |
23.68%
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R&D |
5.26%
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How do clinical research sponsors use AROs?
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Study site only |
46.67%
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Early phase (I and II) |
20.00%
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Late phase (III and IV/PMS) |
20.00%
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Scientific input only |
13.33%
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Product announcements appearing in SmartBrief are paid advertisements and do not
reflect actual AdvaMed endorsements. The news reported in SmartBrief does not necessarily
reflect the official position of AdvaMed.
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| | Recent AdvaMed SmartBrief Issues:
- Thursday, September 27, 2012
- Wednesday, September 26, 2012
- Tuesday, September 25, 2012
- Monday, September 24, 2012
- Friday, September 21, 2012
| | | Lead Editor: Lisa Gough
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