A system that allows intracoronary delivery of blood “supersaturated” with oxygen after coronary stenting has received market approval from the US Food and Drug Administration (FDA), the developer, Therox, announced today.
The SuperSaturated Oxygen (SSO₂) therapy system, indicated for use immediately after stenting for acute ST-segment elevation myocardial infarction (STEMI) in the left-anterior-descending (LAD) coronary artery, aims to limit the extent of acute myocardial ischemia and therefore final infarct size.
The system combines oxygen-supersaturated saline with autologous blood, which is delivered over 60 minutes starting immediately after stenting opens the artery. “The superoxygenated blood helps reduce capillary swelling to restore blood flow to surrounding tissue and decrease infarct size,” according to the company.
The FDA approval marks 10 years since an FDA advisory committeerecommended against the system’s approval, in part to await further safety and efficacy data after clinical end-point concerns in the AMIHOT 2 study, which had been presented in 2007.
A combined analysis of that trial and the preceding AMIHOT trial, as previously reported here, suggested a significant reduction in infarct size by Tc-99m sestamibi single-photon-emission computed tomography (SPECT) 2 weeks after the procedure using SSO₂, compared with a control group, in the patients with large anterior STEMI.
But in AMIHOT 2, there was also a trend toward more major adverse cardiac events (MACE) in the group that received the supersaturated blood treatment.
More recently, the 2018 Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction (IC-HOT) study provided more safety data. It suggested the SSO₂ therapy was safe in 100 patients with STEMI and left-main coronary culprit arteries, finding no elevated risk for a primary end point of death, reinfarction, clinically driven target-vessel revascularization, stent thrombosis, severe heart failure, or TIMI major or minor bleeding.
Therox Receives FDA Approval for First Heart Attack Treatment Since PCI To Reduce Infarct Size. Released April 4, 2019.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.