Explore the most recent editions of MPO Magazine, featuring expert commentary, industry trends, and breakthrough technologies.
Access the full digital version of MPO Magazine anytime, anywhere, with interactive content and enhanced features.
Join our community of medical device professionals. Subscribe to MPO Magazine for the latest news and updates delivered straight to your mailbox.
Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
Learn about outsourcing options in the medical device sector, focusing on quality, compliance, and operational excellence.
Stay updated on the latest electronic components and technologies driving innovation in medical devices.
Discover precision machining and laser processing solutions that enhance the quality and performance of medical devices.
Explore the latest materials and their applications in medical devices, focusing on performance, biocompatibility, and regulatory compliance.
Learn about advanced molding techniques for producing high-quality, complex medical device components.
Stay informed on best practices for packaging and sterilization methods that ensure product safety and compliance.
Explore the latest trends in research and development, as well as design innovations that drive the medical device industry forward.
Discover the role of software and IT solutions in enhancing the design, functionality, and security of medical devices.
Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
Stay updated on innovations in tubing and extrusion processes for medical applications, focusing on precision and reliability.
Stay ahead with real-time updates on critical news affecting the medical device industry.
Access unique content and insights not available in the print edition of the MPO Magazine.
Explore feature articles that delve into specific topics within the medical device industry, providing in-depth analysis and insights.
Gain perspective from industry experts through regular columns addressing key challenges and innovations in medical devices.
Read the editor’s thoughts on the current state of the medical device industry.
Discover the leading companies in the medical device sector, showcasing their innovations and contributions to the industry.
Explore detailed profiles of medical device contract manufacturing and service provider companies, highlighting their capabilities and offerings.
Learn about the capabilities of medical device contract manufacturing and service provider companies, showcasing their expertise and resources.
Watch informative videos featuring industry leaders discussing trends, technologies, and insights in medical devices.
Short, engaging videos providing quick insights and updates on key topics within the medical device industry.
Tune in to discussions with industry experts sharing their insights on trends, challenges, and innovations in the medical device sector.
Participate in informative webinars led by industry experts, covering various topics relevant to the medical device sector.
Stay informed on the latest press releases and announcements from leading companies in the medical device manufacturing industry.
Access comprehensive eBooks covering a range of topics on medical device manufacturing, design, and innovation.
Highlighting the innovators and entrepreneurs who are shaping the future of medical technology.
Explore sponsored articles and insights from leading companies in the medical device manufacturing sector.
Read in-depth whitepapers that explore key issues, trends, and research findings for the medical device industry.
Discover major industry events, trade shows, and conferences focused on medical devices and technology.
Get real-time updates and insights live from the CompaMed/Medica conference floor.
Join discussions and networking opportunities at the MPO Medtech Forum, focusing on the latest trends and challenges in the industry.
Attend the MPO Summit for insights and strategies from industry leaders shaping the future of medical devices.
Participate in the ODT Forum, focusing on orthopedic device trends and innovations.
Discover advertising opportunities with MPO to reach a targeted audience of medical device professionals.
Review our editorial guidelines for submissions and contributions to MPO.
Read about our commitment to protecting your privacy and personal information.
Familiarize yourself with the terms and conditions governing the use of MPOmag.com.
What are you searching for?
Devce is still undergoing clinical trials in the United States.
<!–{cke_protected}{C}%3C!%2D%2D%0A%20%2F*%20Font%20Definitions%20*%2F%0A%40font-face%0A%09%7Bfont-family%3ATimes%3B%0A%09panose-1%3A2%200%205%200%200%200%200%200%200%200%3B%0A%09mso-font-charset%3A0%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A3%200%200%200%201%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-font-charset%3A78%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201791491579%2018%200%20131231%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-font-charset%3A78%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201791491579%2018%200%20131231%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3ACambria%3B%0A%09panose-1%3A2%204%205%203%205%204%206%203%202%204%3B%0A%09mso-font-charset%3A0%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201073743103%200%200%20415%200%3B%7D%0A%20%2F*%20Style%20Definitions%20*%2F%0Ap.MsoNormal%2C%20li.MsoNormal%2C%20div.MsoNormal%0A%09%7Bmso-style-unhide%3Ano%3B%0A%09mso-style-qformat%3Ayes%3B%0A%09mso-style-parent%3A%22%22%3B%0A%09margin%3A0in%3B%0A%09margin-bottom%3A.0001pt%3B%0A%09mso-pagination%3Awidow-orphan%3B%0A%09font-size%3A12.0pt%3B%0A%09font-family%3ACambria%3B%0A%09mso-ascii-font-family%3ACambria%3B%0A%09mso-ascii-theme-font%3Aminor-latin%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-hansi-font-family%3ACambria%3B%0A%09mso-hansi-theme-font%3Aminor-latin%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%0A%09mso-bidi-theme-font%3Aminor-bidi%3B%7D%0Ap%0A%09%7Bmso-style-priority%3A99%3B%0A%09mso-margin-top-alt%3Aauto%3B%0A%09margin-right%3A0in%3B%0A%09mso-margin-bottom-alt%3Aauto%3B%0A%09margin-left%3A0in%3B%0A%09mso-pagination%3Awidow-orphan%3B%0A%09font-size%3A10.0pt%3B%0A%09font-family%3ATimes%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%7D%0A.MsoChpDefault%0A%09%7Bmso-style-type%3Aexport-only%3B%0A%09mso-default-props%3Ayes%3B%0A%09font-family%3ACambria%3B%0A%09mso-ascii-font-family%3ACambria%3B%0A%09mso-ascii-theme-font%3Aminor-latin%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-hansi-font-family%3ACambria%3B%0A%09mso-hansi-theme-font%3Aminor-latin%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%0A%09mso-bidi-theme-font%3Aminor-bidi%3B%7D%0A%40page%20WordSection1%0A%09%7Bsize%3A8.5in%2011.0in%3B%0A%09margin%3A1.0in%201.25in%201.0in%201.25in%3B%0A%09mso-header-margin%3A.5in%3B%0A%09mso-footer-margin%3A.5in%3B%0A%09mso-paper-source%3A0%3B%7D%0Adiv.WordSection1%0A%09%7Bpage%3AWordSection1%3B%7D%0A%2D%2D%3E–Thoratec Corp., a world leader in mechanical circulatory support therapies, received CE mark for its HeartMate PHP (percutaneous heart pump). <!–{cke_protected}{C}%3C!%2D%2D%0A%20%2F*%20Font%20Definitions%20*%2F%0A%40font-face%0A%09%7Bfont-family%3ATimes%3B%0A%09panose-1%3A2%200%205%200%200%200%200%200%200%200%3B%0A%09mso-font-charset%3A0%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A3%200%200%200%201%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-font-charset%3A78%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201791491579%2018%200%20131231%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-font-charset%3A78%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201791491579%2018%200%20131231%200%3B%7D%0A%40font-face%0A%09%7Bfont-family%3ACambria%3B%0A%09panose-1%3A2%204%205%203%205%204%206%203%202%204%3B%0A%09mso-font-charset%3A0%3B%0A%09mso-generic-font-family%3Aauto%3B%0A%09mso-font-pitch%3Avariable%3B%0A%09mso-font-signature%3A-536870145%201073743103%200%200%20415%200%3B%7D%0A%20%2F*%20Style%20Definitions%20*%2F%0Ap.MsoNormal%2C%20li.MsoNormal%2C%20div.MsoNormal%0A%09%7Bmso-style-unhide%3Ano%3B%0A%09mso-style-qformat%3Ayes%3B%0A%09mso-style-parent%3A%22%22%3B%0A%09margin%3A0in%3B%0A%09margin-bottom%3A.0001pt%3B%0A%09mso-pagination%3Awidow-orphan%3B%0A%09font-size%3A12.0pt%3B%0A%09font-family%3ACambria%3B%0A%09mso-ascii-font-family%3ACambria%3B%0A%09mso-ascii-theme-font%3Aminor-latin%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-hansi-font-family%3ACambria%3B%0A%09mso-hansi-theme-font%3Aminor-latin%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%0A%09mso-bidi-theme-font%3Aminor-bidi%3B%7D%0Ap%0A%09%7Bmso-style-priority%3A99%3B%0A%09mso-margin-top-alt%3Aauto%3B%0A%09margin-right%3A0in%3B%0A%09mso-margin-bottom-alt%3Aauto%3B%0A%09margin-left%3A0in%3B%0A%09mso-pagination%3Awidow-orphan%3B%0A%09font-size%3A10.0pt%3B%0A%09font-family%3ATimes%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%7D%0A.MsoChpDefault%0A%09%7Bmso-style-type%3Aexport-only%3B%0A%09mso-default-props%3Ayes%3B%0A%09font-family%3ACambria%3B%0A%09mso-ascii-font-family%3ACambria%3B%0A%09mso-ascii-theme-font%3Aminor-latin%3B%0A%09mso-fareast-font-family%3A%22%EF%BC%AD%EF%BC%B3%20%E6%98%8E%E6%9C%9D%22%3B%0A%09mso-fareast-theme-font%3Aminor-fareast%3B%0A%09mso-hansi-font-family%3ACambria%3B%0A%09mso-hansi-theme-font%3Aminor-latin%3B%0A%09mso-bidi-font-family%3A%22Times%20New%20Roman%22%3B%0A%09mso-bidi-theme-font%3Aminor-bidi%3B%7D%0A%40page%20WordSection1%0A%09%7Bsize%3A8.5in%2011.0in%3B%0A%09margin%3A1.0in%201.25in%201.0in%201.25in%3B%0A%09mso-header-margin%3A.5in%3B%0A%09mso-footer-margin%3A.5in%3B%0A%09mso-paper-source%3A0%3B%7D%0Adiv.WordSection1%0A%09%7Bpage%3AWordSection1%3B%7D%0A%2D%2D%3Thoratec Corp., a world leader in mechanical circulatory support therapies, received CE mark for its HeartMate PHP (percutaneous heart pump).
Thoratec Corp., a manufacturer mechanical circulatory support therapies, received CE mark for its HeartMate PHP (percutaneous heart pump).
Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial examining use of PHP to support patients undergoing a high-risk percutaneous coronary intervention procedure. Data from all 50 patients enrolled in this study will be presented later this year.
HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion. The device has been designed for hemocompatibility, with typical operating revolutions of 17,000-20,000 per minute.
“The SHIELD I clinical experience demonstrated both the performance and ease of use of HeartMate PHP, which was able to safely maintain or improve the hemodynamic profile of severely ill patients undergoing complex revascularizations,” said Dariusz Dudek, M.D., SHIELD I principal investigator and physician in chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland.
“PHP is an entirely new opportunity for Thoratec. Although the current catheter pump market outside the U.S. is relatively small, we look forward to gaining valuable clinical and commercial experience through a targeted European launch of HeartMate PHP in the coming months,” said D. Keith Grossman, president and CEO.
The HeartMate PHP European launch will include a measured rollout to targeted countries, staged through the balance of 2015 and 2016. Previously issued company guidance for 2015 financial results included the expected impact of revenue and costs associated with HeartMate PHP and the European launch, with internal resources principally focused on the HeartMate PHP U.S. investigation device exemption (IDE) study. The SHIELD II U.S. IDE trial recently received unconditional approval from the U.S. Food and Drug Administration and is still expected to begin enrollment during the third quarter.
Pleasanton, Calif.-based Thoratec’s products include the HeartMate II and HeartMate 3 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 and distributes the CentriMag, PediMag/PediVAS, and HeartMate PHP product lines. HeartMate 3 and HeartMate PHP are investigational devices and are limited by U.S. law to investigational use.
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !
