February 28, 2008 - The first human received Medtronic’s investigational bifurcation stent, a Y-shaped design that matches the anatomy of lesions that form at the junctions of coronary arteries, intended to reduce the procedural challenges associated with current two-stent bifurcation techniques.
As part of the BRANCH study, Robert Whitbourn, M.D., 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, 2008. “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 BRANCH study is designed to assess the safety and deliverability of the Medtronic bifurcation stent, which differs from other approaches by providing scaffolding to both branches of the bifurcation simultaneously without overlapping stents. The prospective, single-arm trial 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.
Primary endpoints include cardiac death, myocardial infarction involving the target vessel, and clinically-driven target vessel revascularization (TVR) 30 days post-implant. Other endpoints include device, lesion and procedure success. Expected to be available early in 2009, results from the study will determine whether Medtronic will launch development of a drug-eluting version of the bifurcation stent.
The BRANCH study’s principal investigator is Ian Meredith, professor of cardiology at Monash Medical Centre in Melbourne. “Medtronic’s bifurcation stent provides single-layer, uniform coverage of both the main and side branch,” Meredith explained. “This key feature of the Y-shaped design differentiates it from the current dedicated bifurcation concepts. I am impressed with the flexibility and encouragingly low crossing profile of the stent relative to its design, and believe this new device holds great promise for the treatment of patients with bifurcation lesions, which remain an unsolved clinical challenge in interventional cardiology.”
Of the approximately two million percutaneous coronary interventions (PCIs) performed each year worldwide, an estimated 450,000 (20 percent to 25 percent) involve patients with bifurcation lesions, which are consistently recognized as one of the most difficult lesion types to treat. In addition, PCIs for bifurcation lesions are associated with higher adverse event rates than standard PCIs.
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 reportedly shown deliverability, flexibility and conformability in Medtronic’s commercially available stents.
For more information: www.medtronic.com