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WakeMed News Releases

March 16, 2016
Groundbreaking trial offers new intervention option, potential for improved outcomes for patients

RALEIGH, N.C. (March 16, 2016)WakeMed Health & Hospitals is the second hospital in the United States to treat a cardiac patient with a potentially breakthrough treatment that provides Supersaturated Oxygen (SSO2) Therapy to reduce damage to the heart muscle after a ST elevation myocardial infarction (STEMI), or heart attack.

Called the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, this trial therapy marks the first treatment option beyond Percutaneous Coronary Intervention (PCI) for heart attack patients. The standard of care in treating heart attacks, PCI involves angioplasty and stenting procedures to quickly open blockages and increase blood flow to the heart. Some patients suffer long-term effects from the lack of oxygen that causes a heart attack, such as irreversible damage to the heart muscle and the potential for future heart failure.

“The lack of oxygen and the extent of heart muscle damage following a severe heart attack can carry a poorer prognosis for patients,” said Frances O. Wood, MD, FACC, a board-certified interventional and structural cardiologist with WakeMed Heart & Vascular Physicians. “This important study of SSO2 Therapy may provide physicians with an additional intervention to repair the heart muscle, further improve outcomes and help restore quality of life for our heart attack patients.”

Dr. Wood performed the SSO2 Therapy treatment on February 23 at WakeMed Heart Center, in partnership with Pratik Desai, MD, FACC, of Cary Cardiology. Oxygen therapy was administered to a STEMI patient immediately following a successful coronary angioplasty performed by Dr. Desai. A STEMI is a severe heart attack that occurs when a coronary artery is completely blocked, preventing oxygen-rich blood from reaching the entire heart muscle.

The primary objective of the IC-HOT study – which will enroll 100 subjects at up to 15 U.S. investigational centers – is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in appropriate patients who have undergone successful angioplasty and stenting within six hours of experiencing heart attack symptoms.

According to the American Heart Association, every year nearly one million people in the U.S. have heart attacks, typically caused when the blood flow carrying oxygen to the heart is reduced or blocked. The study is being conducted by TherOx, Inc. to support a PreMarket Approval submission to the FDA and is expected to be completed by December 2016.

About SSO2 Therapy

SSO2 Therapy is intended to provide interventional cardiologists with the first treatment option beyond angioplasty and stenting to salvage heart muscle in heart attack patients. SSO2 Therapy is a solution of highly oxygenated saline mixed with the patient’s blood delivered through a catheter to the targeted area of the heart. SSO2 Therapy is intended to salvage the jeopardized area of the heart muscle and thus reduce the size of the damaged area. This is the second generation SSO2 Therapy system -- the first generation system was successful in a study that demonstrated a relative reduction of 26% in the size of the damaged area of the heart compared to angioplasty and stenting alone.

About WakeMed Health & Hospitals

Serving the community since 1961, WakeMed Health & Hospitals is a nationally recognized, private, not-for-profit health care organization founded and based in Raleigh, N.C. The largest health system in Wake County, WakeMed exists to improve the health and well-being of our community by providing outstanding, compassionate, patient- and family-centered care to all.

The 919-bed system comprises a network of facilities throughout the Triangle area, delivering health and wellness services that bring added value to the communities we serve.

WakeMed is a leader in cardiac and vascular care, women’s and children’s services, emergency medicine and trauma care, physical rehabilitation, orthopaedics and neurosciences. Specialty facilities include the WakeMed Heart Center, Children’s Hospital, Women’s Pavilion and Birthplace, Women’s Hospital at WakeMed North, WakeMed Rehabilitation Hospital, Adult and Children’s Emergency Departments and a Level 1 Trauma Center. WakeMed’s team of more than 8,600 employees, 1,500 volunteers, 1,200 affiliated physicians, and the more than 255 physicians employed by WakeMed Physician Practices use the most advanced technologies along with the best minds and the biggest hearts to ensure the finest quality in health care and community health.

For more information, visit www.wakemed.org.

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