"The results of this adult stem cell study are encouraging news for patients who suffer from serious coronary heart disease but additional clinical investigation is necessary to confirm these findings," said Mariann Gyöngyösi, M.D., Division of Cardiology, University of Vienna Medical Center, Vienna, Austria. "This study is an important step forward in understanding the potential role of adult stem cells in patients with ischemic heart disease."

Six months post-stem cell injection, patients had improved function at the target study site of the left heart ventricle. Improvements included a 4.7 percent increase in the strength of the patient's heart contractions (ejection fraction or EF) (34.8±7.9 percent to 39.5±6.7 percent; p=0.015) and an increase in the movement of the inner heart wall during contraction (linear local shortening or LLS) (5.14±2.90 percent to 6.21±1.66 percent; p=0.035). Additionally, study participants experienced a 4.9 percent decrease in blood flow problems (perfusion defects) after receiving a stress-inducing drug (37.0±10.3 percent to 32.1±13.3 percent; p=0.088).

The study examined 17 patients who were considered unsuitable candidates for conventional treatments such as coronary artery stenting or bypass surgery. Utilizing the investigational MYOSTAR™ Injection Catheter, researchers administered bone marrow-derived stem cells into patients’ left heart ventricle, relying on the NOGA® System to help them accurately identify the target injection site.

"The NOGA® System created highly precise, three-dimensional images of the heart. These images gave us a clear 'map' that helped us to successfully deliver the adult stem cells where we intended them to go," commented Dr. Gyöngyösi. "This imaging technology was critical to making this study possible."

A secondary study finding was that patients experienced higher degrees of cardiac improvement as the number of stem cells administered within the myocardial and coronary tissues increased. This was documented through follow-up measures, including EF (p=0.01, r=0.709), LLS (p<0.05, r=0.628) and stressed-induced (p=0.01, r=0.708) and resting (p<0.01, r=0.722) perfusion defects.

Linear Local Shortening (LLS) was measured with the aid of NOGA® endocardial mapping, a means of visualizing the motion of the inner heart wall by recording its electrical signals. Additional follow-up methods included x-ray, scintigraphy (a diagnostic procedure to create an image of a target organ by giving the patient a radioactive agent known as a radionuclide) and echocardiography (a diagnostic test to visualize the heart and its structures using ultrasound waves).

"We are pleased that the NOGA® System was able to play such an important role in exploring this new frontier of heart disease treatment," said Mark Martin, global clinical manager, Biologics Delivery Systems Group, Cordis Corporation, which distributes the NOGA® System. "This study is a prime example of our commitment to giving physicians and researchers the innovative visualization and delivery technologies they need to explore breakthrough treatments."

About the NOGA® System
The NOGA® Cardiac Navigation System is the most advanced technology currently available on the market to create highly precise, three-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could benefit from a variety of targeted therapies. The NOGA® XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.

The MYOSTAR™ Injection Catheter is not commercially available in the United States and is used only under investigational protocols.

About Biologics Delivery Systems Group
Biologics Delivery Systems Group, Cordis Corporation, is a leader in the emerging field of biologics delivery, developing breakthrough technology in targeted delivery across multiple disease states and clinical specialties. Biologics Delivery Systems Group delivery technology is advancing the standard of care by enabling physicians to identify and visualize optimal delivery sites, and to precisely target single and multiple treatment sites.

About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.