Study designed to provide confirmational data on clinical benefits of SuperSaturated Oxygen Therapy for heart attack patients and financial benefits for healthcare organizations
CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has been enrolled in the SuperSaturated oxygen Comprehensive Observational REgistry (SSCORE). The prospective study is designed to provide further evidence of the efficacy of SuperSaturated Oxygen (SSO2) Therapy to reduce heart failure and mortality in patients suffering from left anterior descending ST-elevation myocardial infarction (LAD STEMI) heart attacks, the most serious type of heart attack. LAD STEMI heart attacks are often referred to as “widow makers” due to the high mortality rate associated with this condition. Additionally, SSCORE will collect data to substantiate the potential improvement in overall healthcare costs associated with prevention of heart failure versus a lifetime of palliative treatment strategies.
The Minneapolis Heart Institute at Abbott Northwestern Hospital, a partner of Allina Health with multiple locations in Minneapolis, Minnesota, is one of the early adopters of the revolutionary SSO2 Therapy, leading to their prominent position as first enroller in the study.
“These patients with LAD occlusion are at significant risk. Opening the artery is the first step but using SSO2 to further decrease infarct size is vital. This patient had an acute proximal LAD occlusion and I wanted to give him the best chance of preserving his heart function,” stated Dr. M. Nicolas Burke, Director of Cardiovascular Emergency Services at Abbott Northwestern, who treated the first patient enrolled in SSCORE nationwide.
“Enrolling the first patient in the SSCORE study marks a significant milestone in advancing the use of SuperSaturated Oxygen Therapy to treat the most severe heart attacks,» said Matt Rochner, General Manager of ZOLL TherOx. «SSO2 Therapy has the potential to not only improve patient outcomes but also reduce the long-term costs of managing heart failure, a significant healthcare challenge. Our partnership with the Minneapolis Heart Institute and Allina Health allows us to advance this cutting-edge technology by collecting more evidence-based clinical and economic data, positioning SSO2 Therapy to become the standard of care for LAD STEMI patients.»
Patients with LAD STEMI heart attacks have higher mortality rates than those with other types of heart attacks. SSO2 Therapy is the first and only FDA-approved treatment that has been clinically proven to significantly reduce damage to cardiac muscle in heart attack patients after coronary angioplasty with stenting.1 The extent of damaged cardiac muscle is a strong predictor of future outcomes like rehospitalization and the development of heart failure.2
SSO2 Therapy is indicated as an adjunct for patients who suffer LAD STEMI and are treated with traditional stenting within six hours of chest pain onset. The therapy delivers high levels of dissolved oxygen (7–10 times the amount normally found in the bloodstream) directly to the damaged heart muscle immediately after the coronary artery has been successfully opened via angioplasty and stenting. Multiple clinical trials have demonstrated the safety and efficacy of SSO2 Therapy to reduce infarct size, a strong predictor of subsequent outcomes.1, 3 -6
“The focus on reducing infarct size and improving microvascular function with SSO2 in the cath lab versus palliation of disease is a logical strategy that has been long awaited in this field,” said Dr. Jay Traverse, Principal Investigator and Researcher at Allina’s Minneapolis Heart Institute Foundation, and an Interventional Cardiologist at Allina’s Minneapolis Heart Institute. “Persistently high readmission rates for these patients, who often develop heart failure following standard-of-care stenting of the LAD, have been an ongoing challenge for over two decades. SuperSaturated Oxygen Therapy has shown great promise to alleviate this problem, which improves the quality of life for the patient while relieving the financial burden on the healthcare system as a whole. We are excited to participate in this trial and look forward to seeing positive outcomes.”
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 www.zoll.com.
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 businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a 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, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.
Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.
1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75.
2 Stone GW et al. J Am Coll Cardiol. 2016;67(14):1674–83.
3 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
4 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.
5 https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2020-ICD-10-PCS-Guidelines.pdf
6 Chen S, et al. Catheter Cardiovasc Interv. 2020; 1–7.
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Contacts
Matt Hogan
ZOLL Medical Corporation
+1 (978) 805-6561
media@zoll.com