Medtronic has initiated the first leg of its BRANCH study, to assess the safety and deliverability of company’s innovative Y stent, “which differs from other approaches by providing scaffolding to both branches of the bifurcation simultaneously without overlapping stents.”
Dr. Robert Whitbourn, associate professor and director of the Cardiovascular Research Centre at St Vincent’s Hospital in Melbourne, performed the first clinical implant of the new device on Feb. 25 as an investigator in the trial, dubbed the BRANCH study. “I left the first case very encouraged by the overall performance of the Medtronic bifurcation stent,” reported Dr. Whitbourn, who also serves as director of the Cardiac Catheterisation Lab and Coronary Intervention at St Vincent’s. “I was especially impressed with its deliverability and believe it has the potential to treat the majority of true bifurcation lesions across the coronary vasculature. Traditional bifurcation techniques require re-crossing of deployed stent struts, overlapping metal, or the potential risk of incomplete coverage of the bifurcation. This device provides a logical solution for addressing these procedural and technical limitations…”
The Medtronic bifurcation stent is intended to reduce the procedural challenges associated with current two-stent bifurcation techniques, which generally require the use of two overlapping stents – one for the main branch, the other for the side branch. Delivered over a dual-wire delivery system through a single catheter, the new stent leverages the latest Medtronic balloon-tapering and -folding technology to minimize the delivery system’s profile. Like other members of Medtronic’s stent portfolio, it is made of an advanced cobalt alloy, which enables the stent struts to be extremely thin while also providing sufficient strength to scaffold the artery. In addition, the investigational bifurcation stent features the same unique modular architecture and custom fusion laser pattern, which have shown excellent deliverability, flexibility and conformability in Medtronic’s commercially available stents (the Driver® bare-metal stent and the Endeavor® drug-eluting stent internationally, including the United States; and the Endeavor Resolute drug-eluting stent outside the United States).