Innovations

Orsiro Drug-Eluting Stent

The Orsiro sirolimus-eluting coronary stent system is built on Biotronik's ultrathin-strut, cobalt-chromium stent platform, the same platform as the Pro-Kinetic Energy bare-metal stent and PK Papyrus covered coronary stent. In the BIOFLOW-V trial, the Orsiro drug-eluting stent demonstrated statistically low patient event rates.^1,2

“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel myocardial infarction rates,” said David Kandzari, MD, United States Principal Investigator of BIOFLOW-V. “BIOFLOW-V data are the best clinical outcomes witnessed with a modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation.” Dr. Kandzari is with the Piedmont Heart Institute in Atlanta, Georgia.

The Orsiro drug-eluting stent is available worldwide.

1. Kandzari DE, Mauri L, Koolen JJ, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularization (BIOFLOW V): a randomized trial. Lancet. 2017;390:1843-1852.

2. Kandzari DE, Koolen JJ, Doros G, et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents: BIOFLOW V 2-year results. J Am Coll Cardiol. 2018;72:3287-3297.

Lotus Edge Aortic Valve System

Boston Scientific Corporation has launched the Lotus Edge aortic valve system, which has received US FDA 510(k) clearance and CE Mark approval. Lotus Edge is a next-generation controlled-expansion transcatheter aortic valve replacement (TAVR) valve featuring a braided nitinol frame and an adaptive seal to minimize paravalvular leak (PVL). Lotus Edge's innovative deployment technology reduces procedural complications and allows the option to reposition the valve, even after full deployment.

“I know that I can get that perfect result with Lotus Edge,” commented Chris Meduri, MD, an interventional cardiologist at Piedmont Atlanta Hospital in Atlanta, Georgia.

In REPRISE III, the first head-to-head pivotal TAVR trial, the Lotus valve platform demonstrated superior effectiveness due to significantly lower moderate PVL and disabling stroke rates, as compared with the Evolut R/CoreValve platforms (Medtronic).¹ Boston Scientific Corporation is currently enrolling patients in the REPRISE IV FDA study, which will evaluate Lotus Edge outcomes in patients at intermediate surgical risk and those with a native bicuspid valve.

The Lotus Edge aortic valve system is available in the United States and the European Economic Area.

1. Feldman TE, Reardon MJ, Rajagopal V, et al. Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: the REPRISE III randomized clinical trial. JAMA. 2018;319:27-37.