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Results from the BIOSOLVE-II Study Reported at TCT 2015 and Published in The Lancet

SAN FRANCISCO – October 12, 2015 – Results from a first-in-man study examining six-month angiographic and clinical outcomes of the newest iteration of a bioresorbable stent made from magnesium alloy demonstrated significant improvement compared to its precursor devices studied in the PROGRESS and BIOSOLVE-I studies.

Findings from the BIOSOLVE-II trial were reported today at the 27^th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in The Lancet.

BIOSOLVE-II was a prospective, international, multicenter, first-in-man study that examined the safety and efficacy of a new magnesium stent coated with poly (l-lactide) and eluting sirolimus. The study enrolled 123 patients with de novo coronary artery stenosis with a primary endpoint of in-segment late lumen loss (LLL) at six months. The primary endpoint results for LLL at six months were 0.27±0.37mm [95% CI: 0.20-0.33] (N=112). The six-month target lesion failure rate (composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and coronary artery bypass graft surgery) was 3.3% [95% CI: 1.3-8.3]. In addition, vasomotion of the scaffolded vessel segment was demonstrated at six months. BIOSOLVE-II also demonstrated low rates of target lesion failure (3.3%) and target lesion revascularization (1.7%) at six months.

The new stent used in BIOSOLVE-II demonstrated significantly improved in-segment LLL (0.27±0.37mm) compared to its precursor devices tested in the BIOSOLVE-I (0.52±0.48mm, p=0.0010) and PROGRESS (0.83±0.51mm, p <0.0001) studies. In addition, a subgroup of 30 patients who underwent intravascular ultrasound (IVUS) analysis revealed that compared to BIOSOLVE-I, the neointimal hyperplasia (NIH) area was reduced by 73% from 0.30±0.41mm² to 0.08±0.09mm².

“The unique design of the magnesium alloy stent provides the strength of metal with the long-term benefit of being absorbed into the body over time,” said co-principal investigator Michael Haude, MD from Lukaskrankenhaus Neuss in Germany.

“The results from BIOSOLVE-II demonstrate significantly improved in-segment late lumen loss at six months for this new stent technology compared to its precursor devices.”

The study was funded by a research grant from Biotronik AG. Dr. Haude reported grant/research support from Biotronik AG, Abbott Vascular, Cardiac Dimensions, Medtronic, Volcano and Lilly as well as consulting fees/honoraria from Biotronik AG.