News | Stents Bioresorbable | May 17, 2016

Magmaris Bioresorbable Magnesium Scaffold Shows Long-Term Safety in BIOSOLVE-II Trial

Twelve-month results demonstrate no incidence of scaffold thrombosis and low rate of target lesion failure and vascular intervention

Biotronik, Magmaris bioresorbable magnesium scaffold, BIOSOLVE-II Trial, 12-month results, EuroPCR 2016

May 17, 2016 — Biotronik 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, what the company calls 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. One hundred twenty-three 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.

Due to the scaffold’s magnesium backbone, it offers novel benefits that only a metallic scaffold can offer such as desired deliverability, strong radial support and a fast resorption time of approximately 12 months. In addition, the BIOlute coating consisting of a sirolimus drug and an excipient ensures a controlled drug release to control cell growth similar to Orsiro, Biotronik’s hybrid drug-eluting stent.

Magmaris is CE mark pending.

For more information: www.biotronik.com

Related Content

Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
Overlay Init