Cordis says stem cells a benefit to heart disease patients; FDA clears NOGA

By Elaine Rigoli

Tampa, Fla., March 15 - Bone marrow-derived adult stem cells administered within the heart (myocardial) and coronary artery tissues of heart disease patients improved patients' heart function and blood flow, according to a Cordis pilot study released Wednesday.

The study also found that patients who received more stem cells experienced a higher degree of cardiac improvement, according to a Cordis news release.

Also on Wednesday, the Food and Drug Administration cleared the NOGA system, a new cardiac navigation technology that was used in the study.

The study examined 17 patients who were considered unsuitable candidates for conventional treatments such as coronary artery stenting or bypass surgery, the release said.

Six months after stem cell injection, patients had improved function at the target study site of the left heart ventricle. Improvements included a 4.7% increase in the strength of the patient's heart contractions and an increase in the movement of the inner heart wall during contraction.

Additionally, study participants experienced a 4.9% decrease in blood-flow problems (perfusion defects) after receiving a stress-inducing drug.

Using 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," said Mariann Gyongyosi, a cardiologist at the University of Vienna Medical Center in Austria, in a statement.

"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, the release said.

Biologics Delivery Systems Group, a Cordis corp., will launch the NOGA XP Cardiac Navigation System, which creates precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies.

The technology is 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 NOGA XP system has been available in Europe since late 2005 and has been well received by physicians, the release said.

Cordis, a Johnson & Johnson company based in Miami, develops interventional vascular technology.

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