Biotronik has announced that the first patient, as part of a clinical study, has been treated with its bioresorbable magnesium Dreams scaffold. BIOSOLVE-II is a prospective, multicentre clinical trial evaluating the safety and efficacy of an improved design of Dreams.
According to a press release, BIOSOLVE-II builds on the results of the BIOSOLVE-I study, which Biotronik says gave valuable insight into the clinical workings of the first generation of the Dreams device. Approximately 120 patients are expected to be enrolled in BIOSOLVE-II, with follow-up investigations performed at one, six, 12, 24, and 36 months. The primary endpoint is in-segment late lumen loss. This study will be used for regulatory approval of the device. It will enrol patients in Germany, Belgium, Denmark, The Netherlands, Switzerland, Spain, Brazil, and Singapore.
The press release reports that Dreams is a bioresorbable scaffold that combines the mechanical advantages of a metallic stent with a reliable bioabsorption profile that serves to open vessels and keep them from re-clogging while avoiding the long-term disadvantages of permanent metal stents.
“I was impressed by the ease of deliverability and vessel adaptability,” comments Michael Haude from the Lukaskrankenhaus, Neuss, Germany, who implanted the Dreams device in the first patient. He adds: “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.”