BIOTRONIK has announced the launch of the BIOMAG-LL pre-market trial to evaluate the Freesolve Resorbable Magnesium Scaffold (RMS).
The trial will test the safety and performance of the Freesolve RMS in treating long de novo lesions in native coronary arteries.
BIOMAG-LL is an international, multi-centre, single-arm study that will enrol 100 patients with de novo coronary artery stenosis and long lesions across Europe.
It will evaluate the Freesolve RMS, which is already CE-certified for shorter lesions, using new device sizes of 35 mm and 40 mm.
According to the Germany-based BIOTRONIK, the goal is to expand its use to longer lesions and support a broader market release.
The first patient was successfully enrolled in the BIOMAG-LL trial at Ergli’s study site at Pauls Stradins Clinical University Hospital in Riga, Latvia, by Inga Narbute.
The study’s primary endpoint is the target lesion failure (TLF) rate at 12 months.
Patients will have clinical follow-up visits at one, six, and 12 months, as well as at three and five years post-procedure.
BIOTRONIK vascular intervention medical affairs vice president Georg Nollert said: “With the BIOMAG-LL study, we’re expanding on the findings from the BIOMAG-I trial, exploring Freesolve’s potential to meet the treatment needs of patients with longer lesions in coronary arteries.
“With this study we aim to prove the efficacy of longer length Freesolve resorbable magnesium scaffolds and bring this unique technology to a broader range of patients.”
The two-year follow-up data from the BIOMAG-I trial, announced in May 2024, confirmed Freesolve RMS as an effective alternative to contemporary drug-eluting stents (DES).
It showed consistently low TLF rates and no cases of scaffold thrombosis.
In the same month, BIOTRONIK also launched the BIOMAG-II randomised controlled trial to compare the clinical outcomes of Freesolve RMS with DES.
In March 2023, the medical technology company secured Breakthrough Device Designation from the US Food and Drug Administration (FDA) for the Freesolve Below-the-Knee Resorbable Magnesium Scaffold (BTK RMS).
BIOTRONIK has also announced a collaboration with Egg Medical to protect interventional healthcare workers from radiation.
The two companies are partnering to sell Egg Medical’s EggNest Radiation Protection System for workers in the US.
Last month, the medical technology firm announced positive interim 24-month data from the BENEFIT-03 trial of its Prospera Spinal Cord Stimulation (SCS) system.
