Zoll’s TherOx SSO₂ Therapy Is Evaluated for Clinical Utility and Economic Value in Postmarket REAL SSO₂ Study

January 17, 2023—Zoll Medical Corporation, an Asahi Kasei company, announced that the first patient has been enrolled in the REAL SSO₂ postmarket study assessing the clinical utility and cost-effectiveness of the company’s TherOx supersaturated oxygen (SSO₂) therapy used after percutaneous coronary intervention (PCI) compared to PCI alone in standard-of-care treatment for ST-elevation myocardial infarction (STEMI) patients.

SSO₂ therapy is used immediately after stenting is performed for left-anterior descending STEMI and within 6 hours of symptom onset. The therapy 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 1 year, and it is the only therapy approved by the FDA to reduce infarct size, stated Zoll. The company announced FDA approval of the second-generation TherOx system in March 2020.

According to the company, the REAL SSO₂ study is a prospective, real-world multicenter 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 to evaluate post event interventions, rehospitalizations, 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’s CathPCI patient registry.

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.

Robert Yeh, MD, and David Cohen, MD, are the study’s Coprincipal Investigators. Dr. Yeh is an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Cohen is Director of Clinical Outcomes & Research at Cardiovascular Research Foundation in New York, New York.

“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,” commented Dr. Yeh in Zoll’s press release. “Given the significant reduction in infarct size already demonstrated through previous clinical studies, we expect to see longer-term improvements in this patient population as compared to primary PCI alone.”