This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: TherOx DownStream System
PMA Applicant: TherOx, Inc.
Address: 17500 Cartwright Rd., Suite 100, Irvine, CA 92614
Approval Date: April 2, 2019
Approval Letter: Approval Order
What is it? The TherOx DownStream System delivers super-oxygenated blood (super-saturated oxygen therapy, or "SSO2") within the heart arteries (specifically, the left anterior descending (LAD) coronary artery) near the damaged area of the heart, following successful placement of a stent.
How does it work? The device creates an oxygen-enriched saline solution called super-saturated oxygen solution ("SSO2 solution"). A small amount of the patient's own blood is mixed with the SSO2 solution, producing super-oxygenated blood. The SSO2 delivery catheter then delivers the super-oxygenated blood within the LAD near the damaged area of the heart . The duration of SSO2 therapy is about one hour.
When is it used? The TherOx DownStream System is used for patients who have recently experienced a heart attack with damage to the left top (anterior) side of the heart muscle and received successful stenting within six hours of the start of heart attack symptoms.
What will it accomplish? The TherOx DownStream System is intended to reduce damage to the heart following a heart attack. In clinical studies, some patients treated with the TherOx DownStream System experienced a reduction in the amount of damaged heart muscle compared with patients with a similar level of risk receiving a stent alone.
When should it not be used? The TherOx DownStream System should not be used in several situations and conditions in patients:
- Who need placement of SSO2 Catheter using a different insertion location in the same artery in the groin as the catheter used to treat the heart attack.
- With an intra-aortic balloon pump.
- With a narrowing of artery where the SSO2 Catheter would be placed.
- With a tear in an artery without a stent after treating the heart attack.
- With narrowed heart valves, inflammation of the tissue sac that surrounds the heart, or a disease of the heart muscle causing an enlarged heart.
- Who are pregnant or nursing.
- With a condition in which the heart suddenly can't pump enough blood to meet the body's needs.
- Who cannot tolerate blood thinners.
- With a contained tear in the heart, a hole between the chambers of the heart, or a leaky mitral valve (the valve between the left atrium and the left ventricle) in the heart.
- With anemia (hemoglobin levels of <10 g/dL).
- Who have bled from the gut or groin within the last two months.
- Who had any major surgery within the last six weeks.
Additional information (including warnings, precautions, and adverse events):