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First Patient Enrolled in REAL SSO2 Study to Evaluate Clinical Utility and Economic Value of ZOLL TherOx SSO2 Therapy
2023-01-17
·
BioSpace
临床研究
CHELMSFORD, Mass.--(BUSINESS WIRE)--
ZOLL
, an
Asahi Kasei
company, announced today that the first patient has enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of
TherOx
SuperSaturated Oxygen (SSO2) Therapy compared to PCI alone in standard of care treatment for
ST-elevation myocardial infarction (STEMI)
patients. The first patient was enrolled by the interventional cardiology team at
St. Mary’s Medical Center
in West Virginia, led by site investigator Mehiar El-Hamdani, MD and study coordinator Cheryl Kane, RN. SSO2 Therapy is used immediately after stenting is performed for
left-anterior descending (LAD) STEMI
heart attacks
— the most severe type — and within six hours of symptom onset. SSO2 delivers high levels of dissolved oxygen directly to the heart to recover damaged tissue. Data have shown that SSO2 Therapy is associated with lower rates of
heart failure
and death within one year,1 and it is the only therapy approved by the FDA to reduce
infarct
size.2 The REAL SSO2 study is a prospective, real-world multi-center, post-market observational study enrolling 750 patients, including both SSO2-treated and control subjects. The study is intended to further demonstrate the clinical and economic value of SSO2 Therapy and evaluate post-event interventions, rehospitalization, and quality of life measures. The real-world data will be collected from the site enrollments in addition to case data from the
American College of Cardiology (ACC)
CathPCI patient registry. A complete overview of the study can be found on ClinicalTrials.gov. “SSO2 Therapy is the newest treatment modality in improving care for
STEMI
patients, and we are thrilled to be leading this study aimed at demonstrating value beyond the acute clinical benefits,” said Robert Yeh, MD, co-principal investigator and interventional cardiologist at
Beth Israel Deaconess Medical Center
. “Given the significant reduction in
infarct
size already demonstrated through previous clinical studies,1 we expect to see longer-term improvements in this patient population as compared to primary percutaneous intervention (PCI) alone.” In addition to Dr. Yeh, the study’s co-principal investigator is David Cohen, MD, Director of Clinical Outcomes & Research at
Cardiovascular Research Foundation
in New York, NY. “The REAL SSO2 study is an important step towards positioning SSO2 Therapy as a standard of care,” said Christopher Barnabas, President of
ZOLL
Circulation. “
ZOLL
is pleased to partner with top institutions and the ACC on this research, and we believe the study outcomes will further demonstrate the positive impact SSO2 Therapy can have for patients who suffer severe
heart attacks
.” About
ZOLL
ZOLL
, an
Asahi Kasei
company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and
sleep apnea
diagnosis and treatment,
ZOLL
provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit . About
Asahi Kasei
The
Asahi Kasei Group
contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business,
Asahi Kasei
has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit .
Asahi Kasei
is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit . Copyright © 2023
ZOLL Medical Corporation
. All rights reserved.
TherOx
and
ZOLL
are trademarks or registered trademarks of
ZOLL Medical Corporation
and/or its subsidiaries in the United States and/or other countries.
Asahi Kasei
is a registered trademark of
Asahi Kasei Corporation
. All other trademarks are the property of their respective owners. 1 Stone, G.W. et al. Circ Cardiovasc Interv; 2; 366-375. Sep 2009. 2
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机构
Beth Israel Deaconess Medical Center, Inc.
St. Mary's Medical Center, Inc.
American College of Cardiology Foundation
[+4]
适应症
STEMI-ST段抬高心肌梗死
ST段抬高心肌梗死
心肌梗塞
[+3]
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