Clinical TMR + stem cell delivery tests basis for Cardiogenesis' U.S.
strategy
June 13, 2008 -- A presentation given this week at the 10th annual
meeting of the International Society of Minimally Invasive
Cardiothoracic Surgeons (ISMICS) by Cardiogenesis Corp. (Irvine,
Calif.) describes the use of the Phoenix delivery system that
combines transmyocardial revascularization (TMR) with autologous bone
marrow derived stem cells. Phoenix is a Holmium YAG Laser system
manufactured by Cardiogenesis (Pink Sheets: CGCP), which is known for
developing surgical products for cardiac revascularization.
Guillermo Reyes, M.D. of La Princesa Hospital (Madrid, Spain) made
the presentation, titled "Transmyocardial Revascularization Combined
with Concentrated Autologous Stem Cells.". It reports a study of 9
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;
-- 7 patients were angina free;
-- Sublingual nitrate use pre procedure was 37 per patient per month
compared to 4 per month at follow up (p=0.03);
-- and 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," stated 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 corporate
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 system was CE Mark approved in November 2006 and has been
used in over 40 procedures at cardiac centers outside the U.S. It is
not currently FDA approved. The company intends to utilize the
clinical experience outside the U.S. to support its clinical and
regulatory strategy in the U.S.
Fri Jun 13 09:27:00 CDT 2008
http://bioopticswor
linical-TMR-
strateg
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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