January 23, 2014 — An implant of the ReZolve2 bioresorbable scaffold was transmitted live via satellite at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 conference in San Francisco.
Reva Medical Inc. collaborated to air the procedure done at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil to an audience at CTC. Dr. Alexandre Abizaid, director of invasive cardiology, and study co-investigator, Dr. J. Ribamar Costa performed the implant.
The scaffold was implanted in a patient with a blockage of the left anterior descending artery of the heart. The lesion was approximately 80 percent blocked and had evidence of moderate calcium. The procedure was performed using a 6 French radial approach, in which the scaffold is delivered to the heart through the radial artery of the wrist.
"We achieved a very successful acute result from this implant,” Dr. Abizaid said. “The scaffold was easily delivered, and the procedure was aided by the complete visibility of the scaffold under X-ray and the ability to achieve the desired implant diameter with a single inflation."
The ReZolve2 clinical trail involves 125 patients, including the one operated on by Dr. Abizaid. Reva will use the data to apply for CE marking in 2014.
12-month data from the RESTORE pilot clinical trial between December 2011 and July 2012 were also presented at TCT. The RESTORE trial was designed to evaluate safety and performance of the first generation ReZolve sirolimus-eluting bioresorbable coronary scaffold. Imaging results of patients treated with ReZolve who remained event free after treatment demonstrated a mean in-stent late loss of 0.29 mm. When imaging results for patients who had undergone retreatment for focal in-stent restenosis the mean in-stent late loss was 0.69 mm.
Reva developed ReZolve2 to reduce incidence of retreatment. The second generation scaffold has an approximate 30 percent increase in radial strength.
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