MN-ST-JUDE-MEDICAL-INC.
6.6.2016 14:01:06 CEST | Business Wire | Press release
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that its CardioMEMS™ HF System was added to the European Society of Cardiology (ESC) guidelines as a directed therapy management and monitoring tool for heart failure patients. The new 2016 ESC Clinical Practice Guidelines for the diagnosis and treatment of acute and chronic heart failure for the first time include pulmonary artery pressure monitoring with the CardioMEMS HF System.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160606005438/en/
Robust clinical data from the CHAMPION study was used to establish this Class IIb recommendation for the CardioMEMS HF System within the guideline directed therapy for heart failure patients.
“The ESC guideline for the CardioMEMS HF System provides direction for physicians who are working to appropriately treat our heart failure patients and reduce their risk of repeated heart failure hospitalizations,” said Dr. Giovanni Battista Perego from Istituto Auxologico Italiano, Milan, Italy.
The data supporting this decision include evidence based on the CHAMPION study and applies to all Class III heart failure patients regardless of their ejection fraction (measurement of how much blood is pumped out of the heart).
CHAMPION clinical data publications include:
- Wireless pulmonary artery hemodynamic monitoring chronic heart failure: a randomized controlled trial (The Lancet)
- Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomized trial (Journal of the American College of Cardiology)
“We are very pleased to see the CardioMEMS HF System was included in the guidelines and congratulate the European Society of Cardiology for working to make this technology more widely available to benefit patients living with heart failure,” said Dr. Philip B. Adamson, medical director and vice president of medical affairs for St. Jude Medical.
The CardioMEMS HF System is the first and only CE Mark approved heart failure monitor that, when used by physicians, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association (NYHA) Class III patients. Long-term, prospective data published in The Lancet supports the effectiveness of the CardioMEMS HF System at reducing heart failure hospitalizations by demonstrating the system can provide physicians with the hemodynamic data to proactively manage their heart failure patients.
The CHAMPION trial originally demonstrated a statistically and clinically significant 28 percent reduction in the rate of HF hospitalizations at six months, and a 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months. The CardioMEMS HF System is the only proven treatment for New York Heart Association (NYHA) Class III Heart Failure patients who have a preserved Ejection Fraction (HFpEF), which makes up approximately half of all heart failure patients.
In addition, recently published data in Circulation: Heart Failure showed that management with the CardioMEMS HF System significantly reduced 30-day hospital readmission rates for Medicare-eligible patients.
Approximately 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed worldwide each year.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3™ left ventricular assist system and our first-to-market MultiPoint™ pacing technology. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.
For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog .
Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com .
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media .
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2016. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160606005438/en/
Contact:
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor
Relations
jweigelt@sjm.com
or
Kristi
Warner, 651-756-2085
Media Relations
kwarner@sjm.com
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom