Compelling Efficacy and Safety Data for Orsiro Hybrid Drug-Eluting Stent Presented during EuroPCR Hotline Session

ORIENT Trial Establishes Orsiro’s Non-Inferiority to Resolute Integrity Stent, while a STEMI Subgroup from the BIOSCIENCE Trial Has 50 Percent Lower TLF Rate vs. Competitor Xience

BUELACH, Switzerland, May 31, 2016 – BIOTRONIK today announced results establishing non-inferiority of the Orsiro hybrid drug-eluting stent (DES) to the Resolute Integrity DES were presented during a Hotline Session at EuroPCR 2016. The multicenter, randomized, controlled all-comers ORIENT trial enrolled 372 patients who received either Orsiro or Resolute Integrity in treatment of a wide variety of coronary heart disease.

“Orsiro’s refined design, including a biodegradable polymer and ultrathin struts, improve patient safety and angiographic outcomes,” commented ORIENT trial principal investigator Dr. Tae-Jin Youn, Seoul National University Bundang Hospital, South Korea. “In this trial, Orsiro conclusively demonstrated non-inferiority to the competitor DES in terms of in-stent late lumen loss.”

The ORIENT trial’s primary endpoint was in-stent late lumen loss (LLL) at nine months, an angiographic endpoint. Orsiro demonstrated significant non-inferiority for the primary end point—at nine months the trial’s Orsiro arm had an average LLL of 0.10 ± 0.35, while patients in the Resolute Integrity arm had an LLL of 0.16 ± 0.39 (P for non-inferiority=<0.001). The trial furthermore highlighted Orsiro’s excellent safety profile, with no stent
thrombosis observed.

At EuroPCR 2016, positive 24 months results for ST-segment elevation myocardial infarction (STEMI) patients were also presented as part of the official program and during a scientific symposium on Orsiro. STEMI is a potentially fatal type of heart attack caused by a prolonged obstruction of blood supply in the heart. Every year nearly 250,000 people experience STEMI heart attacks. A subanalysis of 407 STEMI patients was included in the multicenter, randomized, controlled non-inferiority BIOSCIENCE trial. Results from the trial have been published in The Lancet and EuroIntervention; these had already revealed that Orsiro might be associated with better clinical outcomes than Xience Prime/Xpedition for this indication.

At two years, BIOSCIENCE’s primary endpoint of target lesion failure (TLF) occurred in 5.4 percent of STEMI patients treated with Orsiro compared with 10.8 percent of those treated with Xience Prime/Xpedition. BIOSCIENCE is the largest investigator-initiated study to date evaluating the safety and efficacy of Orsiro, a bioabsorbable polymer DES, in comparison to the durable polymer Xience Prime/Xpedition DES.

“Orsiro continues to prove itself against established competitors in a variety of indications,” stated Dr. Alexander Uhl, Vice President Marketing, BIOTRONIK Vascular Intervention. “As our robust clinical program continues to drive clinical acceptance worldwide, Orsiro has already benefited half a million of patients.”

    About BIOTRONIK:

    At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular and endovascular solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.