BUELACH, SWITZERLAND--(Marketwire - May 16, 2012) - Twelve-month results from the BIOSOLVE-I study with the DRug Eluting Absorbable Metal Scaffold (DREAMS) demonstrate safety and confirm vessel vasomotion. The results from the BIOSOLVE-I study were presented at the European Course on Revascularization in Paris (EuroPCR) by Professor Michael Haude, Lukaskrankenhaus, Neuss, Germany.
At one year, DREAMS demonstrated a low 7.0% rate of target lesion failure with no death or scaffold thrombosis. The target lesion revascularization rate was 4.7%. The analysis showed an in-scaffold late lumen loss of 0.52 mm, which was further reduced from the 6-month results. Vasoreactivity at 12 months did not significantly change from the 6-month results, suggesting that the natural physiology of the vessels was already restored after 6 months of healing and could be sustained.
"The reduction of the 12-month late lumen loss is likely due to plaque regression and late expansive remodeling. At 6 months, we have already seen that vasomotion is restored, so the new results verify that the vessels are naturally adapting to accommodate flow," said Professor Haude. "Additionally, we could further validate that the return of natural vessel angulation that we saw at 6 months was maintained also at 12 months. These results suggest a real restoration of the vessel's natural architecture."
DREAMS is made of a proprietary magnesium alloy coated with a matrix of a bioabsorbable polymer and paclitaxel to inhibit neointimal cell proliferation within the first few months after scaffold implantation. Mechanical properties of the magnesium alloy allow deployment of the device to be comparable to conventional metallic stents.
"The particularly positive feature of the magnesium scaffold is its nice conformability to the vessel wall. A few months after DREAMS implantation, the artery is able to regain its original shape and physiology. This is the main benefit of the magnesium scaffold over the more rigid polymer-based platforms," Professor Haude added.
"These positive one-year results confirm that we are working in the right direction. BIOTRONIK continues to invest in our DREAMS program as we believe that bringing vascular restoration therapy to patients without changing the way physicians implant a scaffold is important to the adoption of this technology," stated Alain Aimonetti, Vice President of Sales and Marketing at BIOTRONIK Vascular Intervention. "An improvement of late lumen loss between 6 and 12 months shows us that the values become more predictable over time. It makes sense, especially for the bioabsorbable scaffolds, to focus on long-term outcomes and not so much on short-term results," Aimonetti concluded. "We see huge potential for DREAMS since it combines deployment and postdilatation properties and long-term outcomes comparable to DES with the additional benefits of vascular restoration therapy."
About the BIOSOLVE-I Clinical Trial
The BIOSOLVE-I first-in-man study is a prospective, multicenter, nonrandomized, European, first-in-man clinical trial evaluating the safety and efficacy of DREAMS. Forty-six patients were enrolled in two cohorts that evaluated the primary endpoint of target lesion failure (TLF) at 6 months for cohort 1 and at 12 months for cohort 2.
About the DRug Eluting Absorbable Metal Scaffold (DREAMS)
DREAMS is part of a revolutionary new treatment option for patients with coronary artery disease. In contrast to existing permanent stents, this device is based on a slow-absorbing, high-strength magnesium backbone. The vessel is not caged as it would be with a permanent implant, thus the artery is able to resume its natural physiology. This novel treatment concept opens a new area of vascular restoration therapy. Properties of the proprietary magnesium alloy allow a straightforward deployment of the device, comparable to conventional metallic stents. BIOTRONIK's DREAMS is coated with antiproliferative paclitaxel to inhibit excess tissue growth during the healing process. The company has announced next-generation platforms under development using the BIOlute® coating from the Orsiro hybrid drug-eluting stent featuring sirolimus as the active compound.
About BIOTRONIK SE & Co. KG
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.
More information: www.biotronik.com
Contact:
Sandy Hathaway
Senior Director, Global Communications
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin - Germany
Tel: +49 (0) 30 68905 1602
E-Mail: sandy.hathaway@biotronik.com
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