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?
CardioMEMS finally secures FDA approval of its primary technology.
<span class="articleLocation”>St. Jude Medical Inc, is buying CardioMEMS—well, the rest of the company it doesn’t already own. The St. Paul, Minn.-based cardiovascular firm plans to exercise its option to buy the shares of Atlanta, Ga.-based CardioMEMS it does not already own for $375 million following the recent U.S. Food and Drug Administration (FDA) approval CardioMEMS’s wireless implantable heart technology that is designed for use in managing patients with heart failure. CardioMEMS received FDA’s blessing on May 28. The CardioMEMS HF (heart failure) System already has inpatient reimbursement from the Centers for Medicare and Medicaid Services. Second time was a charm for CardioMEMS. The FDA has turned the company down the first time it sought approval for it’s technology. The company’s technology records pulmonary artery pressure and transmits it to physicians, who can monitor it remotely and manage the condition. Heart failure occurs when the heart is unable to pump enough blood through the body to meet its demands, pushing up blood pressure in the heart. Increased pulmonary artery pressure can precede worsening heart failure. By being able to monitor a patient’s pulmonary artery pressure remotely, physicians can manage a patients medications and reduce the likelihood of hospitalization, and any technology that will reduce healthcare costs in the short and long terms is a solid bet for future long-range profits, St. Jude is predicting. In September 2010, St. Jude paid $60 million for a 19 percent stake in CardioMEMS, with an exclusive option to buy the remaining 81 percent for $375 million. The company expects to complete the acquisition in the second quarter of this year.
“FDA approval is in line with our expectation and a positive for St. Jude,” Larry Biegelsen, an analyst at Wells Fargo Securities, said in a research note. He estimates CardioMEMS sales will reach $259 million annually by 2018. Michael Weinstein, an analyst at J.P. Morgan, said CardioMEMs “represents a key piece to the growth re-acceleration story at St. Jude.” He added the CardioMEMS system “has the chance to be one of the more meaningful technological advances in heart failure management in recent memory.”
“The CardioMEMS HF System will not only improve the lives of patients but will also reduce the economic burden of this epidemic disease,” Dr. Eric Fain, group president of St. Jude, said in a statement. “We are delighted to have CardioMEMS become a part of St. Jude Medical.”
Atlanta-based CardioMEMS was founded by Jay Yadav, M.D., a cardiologist and entrepreneur and and Mark Allen, a Georgia Tech nanotechnology professor. Yadav serves as the firm’s CEO. Investors in the company include Arcapita Ventures, Boston Millennia Partners and Foundation Medical Partners.
“Hospitalizations are very traumatic for heart failure patients and costly to the healthcare system,” Yadev said. “With the availability of the CardioMEMS heart failure monitoring system, doctors and nurses can now deliver improved and more efficient care to their patients and produce meaningful reductions in their patients’ heart failure related hospitalizations.” Yadav said the company will remain headquartered in Atlanta.
Philip Adamson, M.D., director of the Heart Failure Institute at the Oklahoma Heart Institute and co-principal investigator of the CHAMPION study, the data from which the FDA approval was granted, added: “The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The ‘Hemodynamic Era’ is a major advancement with promise for profound long-term impact on heart failure morbidity.”
Takao Ohki, M.D., chief of vascular surgery at Jikei University in Tokyo, Japan, said, “The ability to get physiologic information wirelessly from patients with heart failure is a great breakthrough and represents the culmination of many years of basic and clinical research.” Yadav noted that the research in heart failure would not have been possible without Dr. Ohki’s pioneering work with the CardioMEMS wireless technology in aortic aneurysms.
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 !