News | Cath Lab | February 22, 2016

TherOx Enrolls First Patient in Supersaturated Oxygen Therapy Study

IC-HOT study will evaluate safety and effectiveness of SS02 therapy in reducing infarct size for acute myocardial infarction patients

TherOx, IC-HOT study, supersaturated oxygen, SSO2 therapy, acute myocardial infarction, AMI

February 22, 2016 — TherOx Inc. announced the first patient has been enrolled in an Investigational Device Exemption (IDE) confirmatory study of its second-generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI). This study is being conducted to support a premarket approval submission to the U.S. Food and Drug Administration (FDA).

“Many heart attack patients suffer from large anterior infarcts after angioplasty and stenting, which carry a poorer prognosis in terms of mortality and the potential for future heart failure,” said Shukri David, M.D., FACC, physician chair of the Heart & Vascular Center of Excellence at St. John Providence Health System near Detroit, Mich., and an investigator for this study. “This important study of SSO2 therapy may provide physicians with an additional intervention that further improves outcomes for our heart attack patients.”

Called the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, it will enroll 100 subjects at up to 15 investigational centers in the United States. The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 therapy in treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

According to the American Heart Association, every year nearly one million people in the United States have heart attacks. Although PCI is the standard of care in treating AMI, for many patients it doesn’t do enough to reduce infarct size and achieve maximum clinical benefit.

SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients.  SSO2 therapy, adjunctive to PCI, is a solution of highly oxygenated saline mixed with the patient’s blood delivered through a catheter to the targeted ischemic area of the heart. The therapy is intended to salvage the jeopardized myocardium and thus reduce infarct size. Multiple peer-reviewed studies have demonstrated the infarct size reduction achieved by SSO2 therapy was clinically significant compared to PCI alone.  

For more information: www.therox.com

Related Content

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init