Interim clinical results from ‘OPEN I’
study of the Stentys bifurcated stent reported at ‘EuroPCR
2008’ international cardiovascular meeting
No device-related events at 30-day follow-up on first-13 patients
PARIS (Business Wire EON/PRWEB ) May 19, 2008 --
Medical device pioneer Stentys
announced today that clinical results from the ‘OPEN
I’ clinical study using its bifurcated
stent were presented at last week’s ‘EuroPCR
2008’ international medical meeting on
cardiovascular intervention.
The data, presented by Eberhard Grube, M.D., Chief of Cardiology
and Angiology at HELIOS Heart Center (Germany) and Principal
Investigator of the OPEN I study, included safety results after 30 days
post-implantation of the Stentys bifurcated stent in the first 13
patients.
“We were very pleased to report that there
were no device-related events at 30 days follow-up of the first 13
patients in our study,” said Dr. Grube. “The
Stentys bifurcation stent seems safe and represents a promising
technique for optimal treatment of bifurcated lesions. The procedure is
identical to known techniques and makes possible excellent
reconstruction of the bifurcation.”
The mean age of the 13 patients was 61 years. Seventy-eight percent of
the lesions were classified as “class B”
(ACC guidelines); 54 percent had lesions in the entire main vessel, both
above and below the bifurcation site. Dr. Grube reported “100%
procedural success”, with no device-related
event during hospitalization and up to 30 days at follow-up.
The annual ‘EuroPCR’
medical meeting contributes to the advancement of education and
information about existing and new technologies in the fields of
cardiovascular intervention.
About Stentys
Based in Paris, Stentys intends to make treatment of blocked coronary
artery bifurcations as simple and effective as a conventional stenting
procedure. The Company has developed the world’s
first next-generation dedicated stent for treatment of blocked
coronary artery bifurcations that is designed so that hundreds of
thousands of patients might avoid open-chest surgery. To date, the
Stentys bifurcated stent has been successfully implanted in patients as
part of the OPEN 1 trial, taking routine interventional time to
complete; the patients were released from the ICU within hours of
implantation of the Stentys bifurcated stent and were discharged from
the hospital shortly after the procedure.
See the original story at: http://eon.businesswire.com/releases/stentys/patients/prweb956034.htm
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