Biotronik Launches Freesolve Resorbable Magnesium Scaffold

February 13, 2024—Biotronik announced its Freesolve resorbable magnesium scaffold (RMS) has received CE Mark, and the device is commercially available in regions accepting CE Mark.

Biotronik noted in its announcement that Freesolve was designed to provide optimized vessel support, while achieving magnesium resorption within 12 months. The company’s BIOMAG-I trial found that Freesolve had 99.3% magnesium strut degradation after 12 months, which Biotronik says was consistent regardless of lesion characteristics and restoration of vasomotion.

The company also reported early data showing that Freesolve RMS achieved a low target lesion failure (2.6%), low clinically driven target lesion revascularization rate (2.6%), no myocardial infarction, and no definite or probable scaffold thrombosis at 12-month follow-up.

“The enhanced properties of the Freesolve RMS can establish a true alternative to [drug-eluting stents], benefitting from the advantages of a resorbable device while maintaining a reliable and predictable outcome with the long-term safety profile that has already been shown in many RMS trials with previous versions,” commented Prof. Michael Haude, of Rheinland Klinikum, in Neuss, Germany. Prof. Haude is Principal Investigator of the BIOMAG-I trial evaluating the Freesolve RMS.

Freesolve RMS continues Biotronik’s line of resorbable magnesium scaffolds, including the Magmaris RMS. According to the company, this new generation device incorporates several technical improvements to address the interventional cardiologists needs and to enable optimal patient outcomes.

As part of the updates, Freesolve RMS uses Biotronik’s Orsio Mission DES delivery system, thinner struts, and new markers for improved radiopacity.