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FDA Advisors Pan Drug-Coated Balloon for Lower-Leg Ischemia


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An FDA advisory committee turned thumbs down on Becton Dickinson s Lutonix 014 drug-coated balloon (DCB) for peripheral artery disease (PAD) during a virtual meeting on Wednesday.
Circulatory System Devices Panel members voted 14-3 (with one abstention) that the benefits of the investigational angioplasty catheter do not outweigh its risks as a treatment for patients with critical limb ischemia (CLI) who have obstructive de novo or non-stented restenotic lesions in below-the-knee (BTK) arteries.
Committee members were largely unconvinced that the Lutonix DCB was supported by adequate efficacy data.
In the pivotal Lutonix BTK IDE trial, the device showed a 10.5% absolute advantage in the primary efficacy endpoint (combined primary patency and limb salvage) at 6 months that was not significant under Bayesian analysis. Such improvement, if any, vanished by 12 months, and the endpoint started to favor the regular percutaneous transluminal angioplast ....

United States , Nicole Lou , Robert Yeh , Bernard Gersh , Bram Zuckerman , Becton Dickinson Lutonix , Joaquin Cigarroa , Oregon Health Science University In Portland , Mayo Clinic College Of Medicine , Harvard Medical School , Circulatory System Devices Panel , Becton Dickinson , System Devices Panel , Oregon Health , Science University , Mayo Clinic College , Medpage Today , Ischemic Colitis , Disorder Of Artery , Disorder Of Blood Vessel , Generalized Atherosclerosis , ஒன்றுபட்டது மாநிலங்களில் , நிக்கோல் லூ , ராபர்ட் ஆமாம் , பெர்னார்ட் கெர்ஷ , பிராம் ஸக்மந் ,

How Technology Integrates into Restaurant Operations


DevPro Journal
How Technology Integrates into Restaurant Operations
Your software solution is only a part of the tech environment a restaurant needs for optimal operations.
December 15, 2020
Consumers often enjoy dining experiences without little notice of the technology supporting them, but as an ISV, you know technology solutions play a role in virtually every facet of restaurant operations. Neil D’Cruz, Sr Product Manager, System Devices Group, Epson America, Inc., points out that using the right hardware and software in the front and back of the house is pivotal to a business’ efficiency and profitability.
Point of Sale (POS) Hardware
POS ISVs spend a great deal of time perfecting their solutions, but even optimal POS software needs the right hardware on which to run. D’Cruz says to ensure your users have the best possible experiences, you need to choose hardware through the lens of a restaurant manager. Your client wants hardware th ....

System Devices Group , Epson America Inc , Epson America , அமைப்பு சாதனங்கள் குழு , எப்சன் அமெரிக்கா இன்க் , எப்சன் அமெரிக்கா ,