Cardiologists on Feb. 25 performed the first clinical implant of Medtroinic’s investigational bifurcation stent, which employs a Y-shaped design to match the anatomy of lesions that form at the junctions of coronary arteries.
The 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, according to Medtronic.
Of the approximately two million percutaneous coronary interventions (PCIs) performed each year worldwide, an estimated 450,000 involve patients with bifurcation lesions, which are consistently recognized as one of the most difficult lesion types to treat, according to Robert Whitbourn MD, director of the Cardiovascular Research Centre at St. Vincent’s Hospital in Melbourne, Australia.
In addition, PCIs for bifurcation lesions are associated with higher adverse event rates than standard PCIs, said Whitbourn, who implanted the stent as an investigator in the trial, dubbed the BRANCH study.
The BRANCH study is a prospective, single-arm trial that will enroll up to 60 patients at five sites in Australia and New Zealand. Enrollment is expected to be complete by the end of 2008 and the device is expected to be available early in 2009, according to Medtronic.
Primary endpoints include cardiac death, myocardial infarction involving the target vessel, and clinically-driven target vessel revascularization 30 days post-implant. Other endpoints include device, lesion and procedure success.