|By PR Newswire||
|August 6, 2014 04:02 PM EDT||
PLEASANTON, Calif., Aug. 6, 2014 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, announced today that its CE Mark Clinical Trial for HeartMate PHPTM (Percutaneous Heart Pump) has commenced.
"We are excited to begin the CE Mark Clinical Trial for HeartMate PHP and look forward to successful execution of this important clinical study," said Gary F. Burbach, President and Chief Executive Officer. "The HeartMate PHP addresses a significant clinical need for acute mechanical circulatory support and represents a new area of future growth for Thoratec," he added.
HeartMate PHP is a percutaneous device designed to deliver short-term support for patients needing acute cardiac assistance. Through a proprietary expandable catheter technology, HeartMate PHP seeks to deliver improvements in device size, performance and clinical outcomes compared with currently available acute support technologies.
A portion of the initial cases in the HeartMate PHP CE Mark trial were performed by Juan F. Granada M.D., Assistant Professor of Medicine at Columbia University in New York and Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation. Dr. Granada performed these cases at the Instituto del Corazón in Bucaramanga, Colombia and commented, "HeartMate PHP offers clinicians a new and effective alternative to address the need for short-term acute cardiac support," adding "the HeartMate PHP performance and ease of deployment are important advancements ideal for usage in this high-risk patient cohort that requires rapid and predictable hemodynamic stabilization." Additional cases in the CE Mark trial were performed by Adrian Ebner M.D., Chief of the Cardiovascular Department at Sanatorio Italiano in Asuncion, Paraguay, where the first human cases using PHP were also successfully completed in 2013.
The HeartMate PHP CE Mark trial will enroll up to 50 patients at sites in Europe and South America. The study will focus on use during high-risk percutaneous coronary interventions (high-risk PCI) and includes a primary endpoint of procedural success and avoidance of major adverse events for 30 days. Dariusz Dudek M.D., Physician in Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland, and principal investigator of the HeartMate PHP CE Mark Trial commented, "On behalf of all the investigators, I wish to congratulate the teams in South America on the initiation of the clinical study. We look forward to treating patients in Europe with HeartMate PHP in the near future."
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate II® LVAS (Left Ventricular Assist Systems) and Thoratec® VAD (Ventricular Assist Device) with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures the CentriMag® and PediMag®/PediVAS® product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's website at http://www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate II are registered trademarks of Thoratec Corporation and HeartMate PHP, is a trademark of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
The preceding paragraphs contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "views," "expects," "plans," "projects," "should," "hopes," "could," "will," "estimates," "potential," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, the development of new products, including development and clinical trial timing , the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of international and FDA regulatory requirements, our ability to address quality issues adequately and on a timely basis without a resulting recall of products or interruption of manufacturing or shipment of products, the effects of healthcare reimbursement and coverage policies, and the effects of competition. Forward-looking statements contained in this press release should be considered in light these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
SOURCE Thoratec Corporation
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
Nov. 23, 2014 02:00 AM EST Reads: 984
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
Nov. 22, 2014 10:00 PM EST Reads: 1,077
Software-driven innovation is becoming a primary approach to how businesses create and deliver new value to customers. A survey of 400 business and IT executives by the IBM Institute for Business Value showed businesses that are more effective at software delivery are also more profitable than their peers nearly 70 percent of the time (1). DevOps provides a way for businesses to remain competitive, applying lean and agile principles to software development to speed the delivery of software that ...
Nov. 22, 2014 08:00 PM EST Reads: 1,440
Docker offers a new, lightweight approach to application portability. Applications are shipped using a common container format and managed with a high-level API. Their processes run within isolated namespaces that abstract the operating environment independently of the distribution, versions, network setup, and other details of this environment. This "containerization" has often been nicknamed "the new virtualization." But containers are more than lightweight virtual machines. Beyond their small...
Nov. 22, 2014 06:45 PM EST Reads: 1,157
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...
Nov. 22, 2014 05:45 PM EST Reads: 1,258
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Nov. 22, 2014 05:30 PM EST Reads: 1,090
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...
Nov. 22, 2014 07:00 AM EST Reads: 1,340
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
Nov. 21, 2014 09:15 PM EST Reads: 1,263
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...
Nov. 21, 2014 08:45 PM EST Reads: 1,222
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the ...
Nov. 21, 2014 08:00 PM EST Reads: 1,340
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Nov. 21, 2014 08:00 PM EST Reads: 1,280
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...
Nov. 21, 2014 07:00 PM EST Reads: 1,265
"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.
Nov. 21, 2014 07:00 PM EST Reads: 1,219