Therox has announced that data from an Investigational Device Exemption (IDE) pilot study of its next-generation supersaturated oxygen (SSO2) therapy will be presented at the upcoming 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (27 October–1 November, San Francisco, USA).
A company press release reports that the study results will be presented by Shukri David, who is section chief of the Division of Cardiology at Providence Hospital near Detroit (USA) and an investigator for this study.
According to the press release, SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients. “We’re very pleased with the early data and its relevance toward our goal of providing substantially better options for treating heart attack patients,” said Kevin T Larkin, president and chief executive officer of Therox.
The first generation system to deliver SSO2 therapy received the CE Mark and met the safety and effectiveness endpoints in the AMIHOT II trial. Statistical results from the AMIHOT II trial of SSO2 therapy, together with PCI and stenting, demonstrated a relative reduction of 26% in infarct size compared to PCI and stenting alone. Also, the finding of device effectiveness was supported by additional analyses that showed a 53% increased likelihood of having a small (less than 5% damage of the left ventricle) infarct among SSO2 Therapy patients. The results were published in Circulation: Cardiovascular Interventions. The press release notes that this second generation system builds on the success of AMIHOT II and includes the additional benefits of shortening the treatment time to 60 minutes and broadening the treatment area to the entire left coronary system so that no ischemic area goes untreated. SSO2 therapy is consistent with the 90-minute “door to balloon” initiative and supports the current guidelines for interventional cardiology procedures.