New BIOSOLVE-IV One-Year Data Underline the Benefit of the Resorbable Magnesium Scaffold for Patients with De Novo Coronary Artery Lesions

Washington, D.C. and BUELACH, Switzerland, March 5, 2019 – Preliminary data from the BIOSOLVE-IV registry strengthen the clinical evidence in favor of BIOTRONIK’s resorbable magnesium scaffold Magmaris1 for de novo coronary artery lesions. Presented as late-breaking clinical data at the Cardiovascular Research Technologies (CRT) meeting, 12-month results from the first 600 patients of the registry showed low target lesion failure (TLF) rates at 5.1% and low incidences of scaffold thrombosis (ST) at 0.5%². The prospective, multi-center BIOSOLVE-IV study with a full cohort of 2,054 patients investigates the clinical performance and long-term safety of Magmaris.

The preliminary results were presented at CRT 2019 by BIOSOLVE-IV clinical investigator Dr. Stefano Galli, Laboratorio di Emodinamica, Centro Cardiologico Monzino, Milan, Italy. “The new results reinforce the perception of magnesium resorbable scaffolds as a safe and efficacious option,” stated Dr. Galli. “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.”

In light of the recent ESC/EACTS guidelines on myocardial revascularization and its recommendations on revascularization with bioresorbable scaffolds (BRS) as Class III C³, BRS technology experienced significant setbacks. Despite the BRS classification, continuously low rates of ST and TLF with Magmaris testify the safety and efficacy of this device even in complex lesions (16.8% of NSTEMI patients)¹. While these results are comparable to those of second-generation modern drug-eluting stents (DES)⁴, the resorbable magnesium scaffold Magmaris has the additional advantage of resorbing into the body within 12 months⁵ after implantation leaving the vessel uncaged.

This unique resorption profile is a key reason Magmaris is unlike any PLLA based BRS. Magmaris consists of a magnesium alloy that allows a fast resorption time: About 95% of the scaffold’s magnesium resorbs within one year after implantation⁵. Early resorption of the scaffold is believed to help prevent very late scaffold thrombosis, a potentially dangerous complication. In contrast, the resorption time for bioresorbable poly-L-lactic (PLLA) scaffolds is three to four years⁶.

“More than 1,400 patients have been enrolled into the Magmaris’ clinical program so far,” explained Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “The new data presented at CRT further supports our conviction that magnesium scaffolds provide unique benefits and are a valuable treatment option in today’s percutaneous coronary interventions.”

During another session at CRT 2019 titled “BRS: Is There A Future to the Technology?”, Prof. Haude, Lukas Hospital, Neuss, Germany, made a strong case for the magnesium resorbable scaffold technology and highlighted its benefits based on pre-clinical and clinical evidence. Prof. Haude further announced the clinical availability in the CE market of the next-generation magnesium resorbable scaffold platform, DREAMS 3G for 2020.

About BIOTRONIK

BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

References

1. Not currently available in the United States. Magmaris is a registered trademark of the BIOTRONIK Group of Companies.
2. Galli S. Safety And Performance of The Resorbable Magnesium Scaffold Magmaris In A Real World Setting - 12-Month Follow-Up of First 600 Subjects in BIOSOLVE-IV Registry. Presented at: CRT, Mar 4, 2019; Washington DC, USA.
3. European Heart Journal (2018) 00, 1–96. ESC/EACTS GUIDELINES.
4. Karjalainen P. Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Resorbable Magnesium Scaffold Implantation in de novo Native Coronary Lesions. Presented at: TCT, Sep 23, 2019; San Diego, USA.
5. Joner M, Ruppelt P, Zumstein P, et al. Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds. EuroIntervention. 2018.
6. Gogas BD, Farooq V, Onuma Y, et al. The ABSORB Bioresorbable Vascular Scaffold: An Evolution or Revolution in Interventional Cardiology? Hellenic J Cardiol 2012; 53: 301-309.