Technology | Cath Lab | April 08, 2019

TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy

SSO2 Therapy treats damaged heart tissue with hyperbaric levels of oxygen during a single catheter-delivered infusion, consistently and safely reducing infarct size

TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy

April 8, 2019 — TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients.

SSO2 Therapy delivers hyperbaric levels of oxygen directly to the ischemic heart muscle immediately after the coronary artery has been successfully opened by PCI (angioplasty and stenting). It is indicated for patients who suffer the most serious kind of heart attacks, left anterior descending ST-elevation myocardial infarction (LAD STEMI) – also known as the widowmaker – treated within six hours of symptom onset. SSO2 Therapy is adjunctively administered immediately following successful stent placement, with no delay in PCI treatment.

“Even after angioplasty with stenting, many heart attack patients suffer from irreversible damage to the heart muscle, which carries a poor prognosis in terms of mortality and the potential for future heart failure,” said Gregg W. Stone, M.D., professor of medicine, Columbia University Medical Center. “SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty.”

According to the American Heart Association, every year approximately 750,000 people in the U.S. have heart attacks. Although PCI has been the standard of care in treating acute myocardial infarction (AMI) for 25 years, many patients do not achieve maximum clinical benefit and suffer from reduced heart function. More than 30 percent of severe AMI patients develop heart failure3 and of those, 50 percent will die within five years.4

SSO2 Therapy has been shown in multiple randomized prospective clinical trials to consistently and safely reduce infarct size in anterior AMI patients and thereby improve outcomes:

  • A pivotal randomized controlled trial demonstrated a 26 percent relative reduction in infarct size compared to PCI alone.1
    • Infarct size reduction correlates strongly with reduction in future complications, including heart failure, hospitalizations and even death.2
  • Additional clinical trial data show left ventricular stability at 30 days with no deleterious enlargement.5,6

For more information: www.therox.com

References

1. Stone GW, et al. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv; 2; 366-375. Sep 2009.

2. Stone, G.W. et al. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016;67(14):1674–83.

3. Gerber, et al. Atherosclerotic Burden and Heart Failure After Myocardial Infarction. JAMA Cardiol. 2016;1(2):156-162.

4. Fitch K, et al. The Cost Burden of Worsening Heart Failure in the Medicare Fee for Service Population: An Actuarial Analysis. Milliman Client Report. March 2017.

5. Warda HM, et al. (2005). "Effect of intracoronary aqueous oxygen on left ventricular remodeling after anterior wall ST-elevation acute myocardial infarction." Am J Cardiol 96(1): 22-24.

6. David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9.

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