Clinical evaluation of the latest generation of bioabsorbable magnesium scaffold for the treatment of vascular disease has begun.
Officials from BIOTRONIK, a leading manufacturer of cardio- and endovascular medical device technology, announce a significant milestone in the development of a new therapy era for patients suffering from coronary artery disease. As part of the clinical study BIOSOLVE-II, Prof. Dr. Michael Haude from the Lukaskrankenhaus, Neuss, Germany, successfully implanted the BIOTRONIK DREAMS (DRug Eluting Absorbable Metal Scaffold) in the first patient.
DREAMS is a bioabsorbable scaffold that 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. Permanent stents cage the vessel segment over the course of the patient's life. In contrast, this device - made of a bioabsorbable magnesium alloy, which is coated with a bioabsorbable polymer matrix and an anti-proliferative Limus drug - is designed to be absorbed over time, leaving a naturally restored vessel.
Building on the results of the BIOSOLVE-I study, which gave BIOTRONIK valuable insight into the clinical workings of the first generation of DREAMS, BIOSOLVE-II is a prospective, multi-center clinical trial evaluating the safety and efficacy of DREAMS in its improved design. Approximately 120 patients are expected to be enrolled, with follow-up investigations performed at 1, 6, 12, 24, and 36 months. The primary endpoint is in-segment late lumen loss (LLL). This study will be used for regulatory approval of the device.
"I was impressed by the ease of deliverability and vessel adaptability," comments Prof. Haude after successful implantation of the first DREAMS scaffold. "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."
"As a global pioneer in bioabsorbable magnesium, BIOTRONIK has refined this technology based on physicians' input to deliver the optimal balance between vessel scaffolding, absorption profile, and drug elution characteristics," comments Dr. Daniel Buehler, president BIOTRONIK Vascular Intervention. "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."
The BIOSOLVE-II study will enroll patients in Germany, Belgium, Denmark, The Netherlands, Switzerland, Spain, Brazil, and Singapore.