Biotronik’s Magmaris Resorbable Magnesium Scaffold Studied in BIOSOLVE-IV Registry Cohort

November 8, 2021—Biotronik announced that new findings from the BIOSOLVE-IV trial of the company’s Magmaris sirolimus-eluting bioresorbable magnesium scaffold were revealed by Professor Johan Bennett, MD, in a poster presentation titled, “Performance and Safety of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting – Primary and Secondary Endpoint Analysis of the Full Cohort (2066 subjects) of the BIOSOLVE-IV Registry,” at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 both online and in Orlando, Florida.

BIOSOLVE-IV is an international, single-arm, multicenter registry conducted in more than 80 centers in 23 countries in Europe, Asia, Africa, Australia, and New Zealand. The registry includes 2,066 patients with a maximum of two single de novo lesions. BIOSOLVE-IV’s patient population encompasses non–ST-segment elevation myocardial infarction patients, diabetic patients, and more complex B2/C lesions, for whom a first cohort subgroup analysis at 1-year follow-up was presented at TCT 2020. Follow-up is scheduled up to 5 years and the primary outcome is target lesion failure (TLF) at 12 months.

According to the company, the superiority of the Magmaris device has been shown with regard to probable or definite scaffold thrombosis compared to an historical control group of data from the Absorb bioabsorbable vascular scaffold (Abbott) in a prospective, powered secondary endpoint of the BIOSOLVE-IV trial. Superiority compared to Absorb is shown with P = .015 (one-sided exact binomial tests α = 0.025).

The new full-cohort, 1-year results presented at TCT confirm the safety and performance of the Magmaris scaffold in a larger cohort. The company highlighted the TLF rate of 5% and a definite/probable scaffold thrombosis rate of 0.8% at 12 months, confirming the safety profile from the first cohort with 1,075 patients.

“The results of the BIOSOLVE-IV study confirm that the Magmaris scaffold is safe and comparable to leading second-generation drug-eluting stents on the market,” commented Prof. Bennett, in Biotronik’s press release. Prof. Bennett, who is one of the registry’s principal investigators, is a coronary interventionalist at the University Hospitals Leuven in Leuven, Belgium.

Prof. Bennett continued, “Importantly, the Magmaris scaffold also proves, for the first time, powered superiority to the Absorb scaffold for definite and probable scaffold thrombosis, an important landmark after the Absorb scaffold raised concerns with notably high rates of scaffold thrombosis compared to contemporary DES. We are excited to see continuous low TLF rates for this bioresorbable scaffold—now in larger and more diverse patient groups.”

Biotronik noted that these recent positive outcomes complement previous BIOSOLVE-IV results such as the first cohort’s 12-month data published by Stefan Verheye, MD, et al in Catheterization & Cardiovascular Interventions (2021;98:E1-E8) and data presented by Professor Jan Torzewski, MD, at the virtual EuroPCR conference in May 2021, showing no increase in scaffold thrombosis between 12-month and 24-month follow-up.