Enrollment Begins for BIOSOLVE-II Study of Biotronik's Bioabsorbable Magnesium Dreams Scaffold

October 14, 2013—Biotronik, Inc. (Lake Oswego, OR) announced the commencement of the BIOSOLVE-II clinical study of the Biotronik Dreams drug-eluting absorbable metal scaffold in the treatment of coronary artery disease. Prof. Michael Haude, MD, from the Lukaskrankenhaus in Neuss, Germany, successfully implanted the device in the first patient in the study.

According to the company, Dreams is a bioabsorbable scaffold that combines the mechanical advantages of a metallic stent with a reliable bioabsorption profile that serves to open vessels and keep them from reclogging while avoiding the long-term disadvantages of permanent metal stents. In contrast to permanent stents, the Dreams device is designed to be absorbed over time, leaving a naturally restored vessel. It is made of a bioabsorbable magnesium alloy that is coated with a bioabsorbable polymer matrix and an antiproliferative limus drug.

BIOSOLVE-II is a prospective, multicenter clinical trial evaluating the safety and efficacy of Dreams in its improved design. The BIOSOLVE-II study will enroll approximately 120 patients in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil, and Singapore. Follow-up investigations will be performed at 1, 6, 12, 24, and 36 months. The primary endpoint is in-segment late lumen loss. BIOSOLVE-II, which will be used for regulatory approval of the device, builds on the results of the BIOSOLVE-I study that gave Biotronik valuable insight into the clinical workings of the first generation of Dreams, stated the company.

Prof. Haude commented in the company's press release after successful implantation of the first Dreams scaffold, “I was impressed by the ease of deliverability and vessel adaptability. Even in quite a challenging lesion like this with significant calcification, the acute performance was similar to a contemporary drug-eluting stent, but offering the advantage of uncaging the vessel in the long run.”