Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
"SSO2 Therapy will support clinicians in delivering the highest quality of care for their [ST-elevation myocardial infarction] patients in Europe and other countries that accept CE mark," said Neil Johnston, president, Zoll Circulation.
The company, part of the Tokyo-based Asahi Kasei Group, received FDA approval for the therapy on March 30, 2020.
SSO2 Therapy is the first treatment since percutaneous coronary intervention (PCI) was approved more than 25 years ago demonstrated to reduce the amount of heart tissue that dies from loss of oxygenated blood following a heart attack. Previous studies demonstrated that the therapy reduced infarct size by a median of 26% more than PCI alone if administered within six hours of an anterior myocardial infarction and by a median of 41% more than PCI alone if administered within three hours.
SSO2 Therapy was developed by Irvine, Calif.-based Therox Inc., which was acquired by Zoll in June 2019, for an undisclosed amount.
The intervention is indicated for patients who have suffered left anterior descending ST-elevation myocardial infarction (LAD STEMI), a type of heart attack commonly called the widow maker because of its high mortality rate. Patients should receive the therapy within six hours of symptom onset.
SSO2 Therapy is the only point-of-care treatment for LAD STEMI patients which results in a predictable reduction in infarct size and improved left ventricular function, said Richard Schatz, research director, Cardiovascular Interventions at Scripps Memorial Hospital in La Jolla, Calif. This can translate to heart failure prevention and patient survival.
About 805,000 Americans have a heart attack each year, according to the CDC. More than 30% of patients who experience severe heart attacks go on to develop heart failure and half of those patients will die within five years, the CDC reports.
PCI restores coronary blood flow following an AMI, but may not avert the microvascular damage and tissue death that contribute to heart failure. Reducing the amount of tissue damaged by an AMI is correlated with reduced rates of heart failure and mortality as well as better post-AMI left ventricular function.
The technology
SSO2 Therapy combines in-hospital oxygen and saline to create a superoxygenated solution which is mixed with the patients arterial blood in the systems cartridge to increase the oxygen level to 10 times normal (1,000 mmHg).
Immediately after successful PCI, the highly oxygenated blood is returned via a catheter into the left coronary artery. The catheter uses the same femoral access site as the PCI procedure.
The one-time, 60-minute infusion provides a high concentration of oxygen that increases the diffusive transfer of oxygen directly to parts of the myocardium that suffered oxygen deprivation during the heart attack. The technology does not depend on blood flow, so oxygen can reach endothelial cells of capillaries, reverse swelling in the microvasculature, restore flow and return tissue to normal oxygen levels in the areas of the heart at risk of damage.
Increased ventilator production
Beyond the SSO2 Therapy, Zoll also develops and markets medical devices and software solutions for emergency care settings, including ventilators for hospitals, emergency medical services, and the military.
In late March, the company committed to increasing its manufacturing capacity to enable the production of 10,000 ventilators a month in response to the COVID-19 pandemic. The goal represented a 2,500% increase in production.
"As we strive to meet the increased demand, we have the benefit of a large, highly trained workforce and a state-of-the-art factory," said Zoll CEO Jon Rennert, "and are prepared to expand our supply base as necessary. We have received many unsolicited offers of help from not just medical companies, but industries including aerospace, automotive, and information technology. We look forward to working with the U.S. government and private industry collaborators to meet this urgent need."
When BioWorld asked for an update on ventilator production, Zoll declined comment beyond noting, [v]entilators are comprised of hundreds of individual parts from dozens of primary suppliers, who in turn rely on hundreds of secondary suppliers. Like most products, the supply base is global. Final assembly and quality assurance testing are the last steps in a long process.
The company is working hard to ramp up production, Zoll spokesperson Diane Egan told BioWorld.
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Zoll's Supersaturated Oxygen Therapy receives CE mark - BioWorld Online
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