Cardiogenesis (Irvine, California), a developer of surgical products for cardiac revascularization, reported a scientific presentation that describes the use of the Phoenix delivery system combining transmyocardial revascularization (TMR) with autologous bone marrow derived stem cells.

The presentation, titled "Transmyocardial Revascularization Combined with Concentrated Autologous Stem Cells," was presented by Guillermo Reyes, MD, of La Princesa Hospital (Madrid, Spain) at the 10th annual meeting of the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) on June 12 in Boston.

Reyes reported on the use of the Phoenix system, a Holmium YAG Laser TMR and biologic combination delivery system manufactured by Cardiogenesis. Reyes presented on a series of nine patients with diffuse coronary artery disease and medically refractory class III/IV angina that were treated by the application of TMR in combination with bone marrow derived stem cells in targeted ischemic heart muscle. At an average follow up of 6 months:

• All patients experienced at least a two class reduction in angina.

• Seven patients were angina-free.

• Sublingual nitrate use pre-procedure was 37 per patient per month compared to four per month at follow up.

• There were no perioperative adverse events including no arrhythmias.

The hypothesis for the study is an enhanced cell uptake and angiogenic effect when delivering concentrated bone marrow derived stem cells to the stimulated tissue border zone surrounding the TMR channels at the time of surgery.

"These initial clinical results utilizing the Phoenix delivery system are very promising," said Richard Lanigan, president of Cardiogenesis, "and they build upon the growing body of evidence that our Holmium YAG TMR system has a favorable impact on cell retention and survival in cardiac tissue as described by Dr. Amit Patel in a recent animal study published in Cell Transplantation. "Our focus is to build on this early work and provide clinicians effective tools to treat the large patient population suffering from refractory angina, be it as sole therapy or concomitant with coronary bypass."

The Phoenix combination delivery system was CE mark-approved in November 2006. It has been used in more than 40 procedures at cardiac centers outside the U.S. It is not currently FDA approved. The company said it intends to utilize the clinical experience