|By PR Newswire||
|February 18, 2014 07:03 AM EST||
SANTA ROSA, Calif., Feb. 18, 2014 /PRNewswire/ -- Claret Medical, Inc., a developer of innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures, announced that it has received Investigational Device Exemption (IDE) approval from the FDA for a multicenter study of the Company's Sentinel Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
"Protecting cerebral vasculature from embolic debris liberated from multiple sources during TAVR procedures continues to be a critical safety challenge. Recent studies have validated that macroscopic material liberated during these procedures can be effectively captured and safely removed using Claret Medical's dual filter embolic protection system," commented Martin Leon, M.D., Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the trial's Clinical Steering Committee. "We expect the results of the SENTINEL trial to confirm the importance of embolic debris capture and removal during TAVR and to further elucidate the neurocognitive implications of such embolic protection."
The SENTINEL study will evaluate the Sentinel CPS during TAVR as compared to the standard of care. Primary endpoints include reduction in total new lesion volume by diffusion-weighted magnetic resonance imaging (DW-MRI) and rate of major adverse cardiac and cerebrovascular events (MACCE). The study will be conducted at up to 15 centers and will begin in the first quarter of 2014.
"This is another step forward in advancing our unique filter-based technology for cerebral protection during TAVR," said Azin Parhizgar, Ph.D., President and CEO of Claret Medical. "We look forward to initiating the study and providing physicians the confidence and control needed to capture and remove embolic debris liberated during TAVR procedures – debris that could otherwise be a source of peri-procedural stroke in this patient population." Dr. Parhizgar continues, "I am especially pleased that our comprehensive and collaborative pre-IDE discussions allowed us to receive timely approval to conduct the first randomized clinical study in the US for evaluating the role of cerebral protection during TAVR."
Claret Medical is the leader in cerebral protection during TAVR in the European Union since 2012.
About Claret Medical
Claret Medical is a privately held company focused on innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures. Claret Medical is currently focusing developmental and clinical research resources on addressing the problem of stroke during TAVR, a significant unmet clinical need.
Claret Medical, Inc.
SOURCE Claret Medical, Inc.
ScriptRock makes GuardRail, a DevOps-ready platform for configuration monitoring. Realizing we were spending way too much time digging up, cataloguing, and tracking machine configurations, we began writing our own scripts and tools to handle what is normally an enormous chore. Then we took the concept a step further, giving it a beautiful interface and making it simple enough for our bosses to understand. We named it GuardRail after its function - to allow businesses to move fast and stay sa...
Dec. 22, 2014 08:30 AM EST Reads: 977
SYS-CON Media announced today that Sematext launched a popular blog feed on DevOps Journal with over 6,000 story reads over the weekend. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting an...
Dec. 22, 2014 08:00 AM EST Reads: 944
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Dec. 22, 2014 05:00 AM EST Reads: 1,328
In high-production environments where release cycles are measured in hours or minutes — not days or weeks — there's little room for mistakes and no room for confusion. Everyone has to understand what's happening, in real time, and have the means to do whatever is necessary to keep applications up and running optimally. DevOps is a high-stakes world, but done well, it delivers the agility and performance to significantly impact business competitiveness.
Dec. 21, 2014 07:00 PM EST Reads: 976
"Our premise is Docker is not enough. That's not a bad thing - we actually love Docker. At ActiveState all our products are based on open source technology and Docker is an up-and-coming piece of open source technology," explained Bart Copeland, President & CEO of ActiveState Software, in this SYS-CON.tv interview at DevOps Summit at Cloud Expo®, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 21, 2014 06:00 PM EST Reads: 2,044
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover ...
Dec. 21, 2014 02:00 PM EST Reads: 2,390
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 21, 2014 01:00 PM EST Reads: 2,011
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com...
Dec. 21, 2014 11:30 AM EST Reads: 2,428
Verizon Enterprise Solutions is simplifying the cloud-purchasing experience for its clients, with the launch of Verizon Cloud Marketplace, a key foundational component of the company's robust ecosystem of enterprise-class technologies. The online storefront will initially feature pre-built cloud-based services from AppDynamics, Hitachi Data Systems, Juniper Networks, PfSense and Tervela. Available globally to enterprises using Verizon Cloud, Verizon Cloud Marketplace provides a one-stop shop fo...
Dec. 21, 2014 11:00 AM EST Reads: 2,017
Leysin American School is an exclusive, private boarding school located in Leysin, Switzerland. Leysin selected an OpenStack-powered, private cloud as a service to manage multiple applications and provide development environments for students across the institution. Seeking to meet rigid data sovereignty and data integrity requirements while offering flexible, on-demand cloud resources to users, Leysin identified OpenStack as the clear choice to round out the school's cloud strategy. Additional...
Dec. 21, 2014 11:00 AM EST Reads: 1,990
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada...
Dec. 21, 2014 10:00 AM EST Reads: 2,163
SYS-CON Media announced today that Aruna Ravichandran, VP of Marketing, Application Performance Management and DevOps at CA Technologies, has joined DevOps Journal’s authors. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Aruna's inaugural article "Four Essential Cultural Hacks for DevOps Newbies" discusses how to demonstrate the...
Dec. 21, 2014 10:00 AM EST Reads: 1,813
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Dec. 21, 2014 10:00 AM EST Reads: 2,067
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, p...
Dec. 21, 2014 08:30 AM EST Reads: 2,301
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are conf...
Dec. 21, 2014 06:30 AM EST Reads: 2,010