Interventional radiology device developer Boston Scientific reported the implantation of its Taxus petal bifurcation paclitaxel-eluting stent system in a patient in New Zealand, marking the beginning of the Taxus petal I first human use (FHU) trial, according to the Natick, Mass.-based company.
The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease. The procedure was performed by Dr. John Ormiston at Auckland City Hospital in Auckland, New Zealand.
The Taxus petal stent consists of a traditional drug-eluting stent with a petal strut in the middle of the stent that opens into an artery’s side branch. The device is designed to provide access, coverage, and support to areas of the bifurcation and uses a proprietary platinum chromium alloy, Boston Scientific said.
The Taxus Petal I FHU trial will enroll a total of 45 patients in New Zealand, France, and Germany. Upon successful completion of this study, the company said it intends to begin a trial to gain U.S. and international approval for the commercialization of the device.