Sam Brusco, Associate Editor01.17.23
ZOLL announced the first patient has been enrolled in its REAL SSO2 post-market observational study, which will assess clinical utility and cost-effectiveness of its TherOx SuperSaturated Oxygen (SSO2) therapy compared to PCI alone in standard-of-care treatment for ST-elevation myocardial infarction (STEMI).
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 right after stenting for left-anterior descending (LAD) STEMI heart attacks (the most severe type) and within six hours of symptom onset. It delivers high levels of dissolved oxygen to the heart to recover damaged tissue.
The REAL SSO2 study will enroll 750 patients to further demonstrate SSO2 therapy clinical and economic value and evaluate post-event interventions, rehospitalization, and quality of life measures. The real-world data will be collected from site enrollments and case data from the American College of Cardiology CathPCI patient registry.
“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,” Robert Yeh, MD, co-principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center, told the press. “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.”
“The REAL SSO2 study is an important step towards positioning SSO2 Therapy as a standard of care,” added 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.”
Reference
1 Stone, G.W. et al. Circ Cardiovasc Interv; 2; 366-375. Sep 2009.
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 right after stenting for left-anterior descending (LAD) STEMI heart attacks (the most severe type) and within six hours of symptom onset. It delivers high levels of dissolved oxygen to the heart to recover damaged tissue.
The REAL SSO2 study will enroll 750 patients to further demonstrate SSO2 therapy clinical and economic value and evaluate post-event interventions, rehospitalization, and quality of life measures. The real-world data will be collected from site enrollments and case data from the American College of Cardiology CathPCI patient registry.
“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,” Robert Yeh, MD, co-principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center, told the press. “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.”
“The REAL SSO2 study is an important step towards positioning SSO2 Therapy as a standard of care,” added 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.”
Reference
1 Stone, G.W. et al. Circ Cardiovasc Interv; 2; 366-375. Sep 2009.