17
May
2016
|
00:00
Europe/Amsterdam

EuroPCR 2016: Magmaris*, the First Clinically Proven Bioresorbable Magnesium Scaffold, Shows Long-Term Safety in BIOSOLVE-II Trial

12 Month Results Demonstrate No Incidence of Scaffold Thrombosis and Low Rate of Target Lesion Failure

PARIS, France and BUELACH, Switzerland, May 17, 2016 – BIOTRONIK today presented 12 month data from the BIOSOLVE-II trial during a Hotline Session at EuroPCR 2016. The study established the safety and clinical performance of Magmaris*, the world’s first clinically proven magnesium-based sirolimus eluting bioresorbable scaffold. Full one year data from the prospective, international first-in-human trial has been published in The European Heart Journal concurrently with the Hotline Session.

“These results offer the first confirmation of Magmaris’s* longer-term safety and efficacy,” stated BIOSOLVE-II principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany. “BIOSOLVE-II demonstrates a promising potential of a magnesium-based approach to treating coronary artery disease as an alternative to polymer-based bioresorbable scaffolds.”

BIOSOLVE-II is the first trial to evaluate the safety and clinical performance of Magmaris*. 123 patients with de novo lesions were enrolled in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil and Singapore. The trial’s primary endpoint was in-segment late lumen loss (LLL) at six months, with an LLL of 0.27 ± 0.37 mm observed at six months. The voluntary 12 month follow-up now reports an LLL of 0.25 ± 0.22 mm. Magmaris* had previously met its primary angiographic endpoint and demonstrated an outstanding safety profile at six months; the results were published in The Lancet.

Particularly encouraging from the perspective of device safety was the total absence of stent thrombosis at 12 months. Furthermore, a low rate of target lesion failure (TLF) of 3.4 percent was observed at six months, with no additional TLF occurring between six and 12 months.

“BIOSOLVE-II has paved the way for a novel magnesium bioresorbable scaffold which offers outstanding deliverability without leaving an implant behind,” commented Dr. Daniel Buehler, BIOTRONIK President, Vascular Intervention. “The current clinical evidence will be augmented with a robust post-market clinical program, including the BIOSOLVE-IV trial.”

  1. CE mark pending

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.