Sam Brusco, Associate Editor05.13.24
Biotronik has enrolled the first patient in its BIOMAG-II trial, which will evaluate its new-generation Freesolve resorbable magnesium scaffold (RMS) against a contemporary drug-eluting stent (DES).
The BIOMAG-II international study will span 21 countries in the Europe and Asia-Pacific region. It has an enrollment target of 1,859 patients with de novo coronary in-stent restenosis. The study’s primary endpoint is target lesion failure (TLR) rate at 12 months.
Follow-up visits will occur at one, six, and 12 months, then annually for up to five years post-procedure.
"We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG - University Hospital Geneva in Switzerland. "Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise."
According to Biotronik, previous BIOMAG-I study results showed excellent outcomes regarding late lumen loss and TLF at six and 12 months. OCT imaging confirmed that Freesolve struts aren’t visible anymore at 12 months after implantation, and the magnesium is fully resorbed.
Freesolve’s U.S. investigational device exemption (IDE) study and other international studies are in the preparation phase, the company said.
“The BIOMAG-II study marks an exciting pivot point in how we treat patients with coronary artery disease, aiming to highlight the safety and effectiveness of our Freesolve resorbable magnesium scaffold. With solid clinical evidence at our core, we're dedicated to introducing innovative solutions that truly make a difference and enable patients to live an implant-free future,” said Prof. Dr. Georg Nollert, VP medical affairs, Vascular Intervention at Biotronik.
Earlier this year, the company earned U.S. Food and Drug Administration (FDA) breakthrough status for Freesolve’s use below-the-knee (BTK).
The BIOMAG-II international study will span 21 countries in the Europe and Asia-Pacific region. It has an enrollment target of 1,859 patients with de novo coronary in-stent restenosis. The study’s primary endpoint is target lesion failure (TLR) rate at 12 months.
Follow-up visits will occur at one, six, and 12 months, then annually for up to five years post-procedure.
"We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish resorbable metallic scaffolds as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve resorbable magnesium scaffold," said Dr. Juan F. Iglesias, HUG - University Hospital Geneva in Switzerland. "Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise."
According to Biotronik, previous BIOMAG-I study results showed excellent outcomes regarding late lumen loss and TLF at six and 12 months. OCT imaging confirmed that Freesolve struts aren’t visible anymore at 12 months after implantation, and the magnesium is fully resorbed.
Freesolve’s U.S. investigational device exemption (IDE) study and other international studies are in the preparation phase, the company said.
“The BIOMAG-II study marks an exciting pivot point in how we treat patients with coronary artery disease, aiming to highlight the safety and effectiveness of our Freesolve resorbable magnesium scaffold. With solid clinical evidence at our core, we're dedicated to introducing innovative solutions that truly make a difference and enable patients to live an implant-free future,” said Prof. Dr. Georg Nollert, VP medical affairs, Vascular Intervention at Biotronik.
Earlier this year, the company earned U.S. Food and Drug Administration (FDA) breakthrough status for Freesolve’s use below-the-knee (BTK).