Paris, France, May 18, 2011 – Six-month results from the BIOSOLVE-I first-in-man (FIM) trial, studying the DRug-Eluting Absorbable Metal Scaffold (DREAMS), demonstrate a high safety profile of the novel device. For the first cohort of 22 patients, there was no cardiac death, no target vessel myocardial infarction (MI) and no stent thrombosis, as presented at the European Conference of Paris Course on Revascularization (EuroPCR) by Professor Michael Haude, Lukas Hospital, Neuss, Germany, one of the investigators of the study.
The BIOSOLVE-I study is a prospective, multicenter, nonrandomized, European, FIM trial evaluating the safety and efficacy of DREAMS. The primary endpoint is target lesion failure (TLF) at 6 months for cohort 1 and at 12 months for cohort 2. Major secondary endpoints are cumulative major adverse coronary event rates at 1 month, 6 months and 12 months, as well as at 2 years and 3 years; in-scaffold and in-segment late luminal loss are measured at 6- and 12-month follow-ups. In addition to the quantitative coronary angiography (QCA) follow-up, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging are performed at 6 months and 12 months. Vasomotion assessment is completed at the same time points.
Between July and December 2010, 47 DREAMS were implanted in 46 patients. The 6-month outcomes reveal two cases of target lesion failure (9.1%) reflected only by clinically driven target lesion revascularization. The angiographic in-scaffold late lumen loss outcome is 0.68 mm.
“These outcomes demonstrate a considerable improvement over the bare version of the absorbable metal scaffold and confirm that the development strategy is taking the right direction,” commented Professor Haude.
Professor Haude also highlighted the superior mechanical properties of the DREAMS scaffold compared with absorbable scaffolds made of polymeric materials. “DREAMS’ expansion behavior is very similar to a permanent metallic stent,” he reported. “Also, its appearance in OCT at the baseline procedure looks like a permanent metallic stent.”
The drug-eluting absorbable metal scaffold is part of a revolutionary new treatment option for patients with coronary artery disease. In contrast to existing permanent stents, this device, based on an absorbable magnesium backbone, degrades over time and leaves nothing behind but a healed vessel that can resume its natural functionality.
DREAMS is made of a proprietary magnesium alloy coated with a matrix of a degradable polymer and paclitaxel to inhibit neointimal cell proliferation within the first few months after scaffold implantation. DREAMS, a novel treatment concept designed to eliminate the long-term risks associated with a permanent implant, opens a new area of vascular restoration therapy.
“Looking at the results of the first cohort only, the outcomes of DREAMS confirm a very good safety profile of the absorbable scaffold. While we believe that 6-month outcomes indicate a tendency, longer follow-up periods are necessary before we would draw confident conclusions about this novel therapy,” stated Alain Aimonetti, Vice President Marketing and Sales with BIOTRONIK. “As we have previously seen with vascular restoration therapy, 12-month results play an important role after proper healing and remodeling of the vessels.”
More OCT and IVUS results are expected to be presented at TCT 2011. For more information about the BIOTRONIK portfolio, visit www.biotronik.com
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.