Therox has released results from its multicentre Investigational Device Exemption (IDE) pilot study of its next-generation system for supersaturated oxygen (SSO2) therapy. The results, which were presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (27 October–1 November, San Francisco, USA), had a 9.6% median infarct size measured at 30 days.
According to a press release, in a previous prospective, multicentre, randomised IDE trial, AMIHOT II, patients treated with the first-generation SSO2system had a 20% infarct size, and control group patients treated with percutaneous coronary intervention (PCI) alone had a 26.5% median infarct size. The pilot IDE study enrolled 20 patients at three prominent cardiac centres in the USA.
The second-generation SSO2 therapy system was designed to improve therapeutic effectiveness by perfusing the entire left coronary system so that no ischaemic area goes untreated. It also offers the additional benefit of shortening the treatment time to 60 minutes from 90 minutes. The original system only perfused the target artery treated with angioplasty and stenting.
“In the successful AMIHOT II study performed with the prior system, SSO2 therapy was proven to reduce median infarct size by 26%, which is statistically significant. The new SSO2 system shows promise in producing even better results,” said Shukri David, FACC, section chief of the Division of Cardiology at Providence Hospital near Detroit and the investigator for this study who presented the results at TCT.