Biotronik, a manufacturer of cardio and endovascular medical devices, has announced that its DREAMS scaffold (DRug Eluting Absorbable Metal Scaffold) has been successfully implanted in the first coronary artery disease patient in Germany as part of the BIOSOLVE-II clinical study.
DREAMS scaffold is made from a bioabsorbable magnesium alloy, which is coated with a bioabsorbable polymer matrix and an anti-proliferative Limus drug.
The bioabsorbable scaffold has been designed to be absorbed over time, leaving a naturally restored vessel.
According to the company, this device combines the superior 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.
Biotronik vascular intervention president Dr Daniel Buehler noted as a global pioneer in bioabsorbable magnesium, the company has refined this technology based on physicians’ input to deliver the optimal balance between vessel scaffolding, absorption profile, and drug elution characteristics.
"With the promising clinical data of our first generation in the BIOSOLVE-I study, and the preclinical data of this new generation, I am confident that this groundbreaking treatment will prove its efficacy," Dr Buehler added.
The BIOSOLVE-II, a prospective, multi-center clinical trial is designed to assess the safety and efficacy of DREAMS in its improved design and the primary endpoint is in-segment late lumen loss.
Around 120 patients are anticipated to be enrolled in the study, with follow-up investigations performed at one, six, 12, 24, and 36 months.
The BIOSOLVE-II trial will enroll patients in Germany, Belgium, Denmark, The Netherlands, Switzerland, Spain, Brazil, and Singapore.
Biotronik will use this study for regulatory approval of DREAMS scaffold.