One-Year Data Presented From BIOSOLVE-IV Registry for Biotronik's Resorbable Magmaris Scaffold
March 5, 2019—Biotronik announced that preliminary results of the BIOSOLVE-IV study were presented by Clinical Investigator Stefano Galli, MD, as late-breaking clinical data at CRT 2019, the Cardiovascular Research Technologies annual meeting held March 2–5 in Washington, DC.
The prospective multicenter BIOSOLVE-IV registry, with a full cohort of 2,054 patients, is evaluating the clinical performance and long-term safety of the company's Magmaris resorbable magnesium scaffold for de novo coronary artery lesions. The preliminary data strengthen the clinical evidence in favor of the device, stated the company.
Twelve-month results from the first 600 patients of the registry showed low target lesion failure (TLF) rates at 5.1% and low incidence of scaffold thrombosis (ST) at 0.5%.
In the company's announcement, Dr. Galli commented, “The new results reinforce the perception of magnesium resorbable scaffolds as a safe and efficacious option. Especially younger patients with a long life expectancy can benefit from this technology, which may enable a future intervention years ahead as the disease may progress. Moreover, the relatively quick resorption time should help avoid late complications.”
These continuously low rates of ST and TLF with Magmaris support the safety and efficacy of this device even in complex lesions. With results comparable to those of second-generation modern drug-eluting stents, the resorbable magnesium scaffold Magmaris has the additional advantage of resorbing into the body within 12 months after implantation, leaving the vessel uncaged, stated Biotronik.