Orsiro Demonstrates Benefit over Xience in Heart Attack Subgroup

Lower Rate of Target Lesion Failure with Orsiro for ST-Segment Elevation Myocardial Infarction Patients in Randomized Controlled BIOSCIENCE Trial

BUELACH, Switzerland, February 18, 2016 – BIOTRONIK, a global leader in cardio- and endovascular medical technology, today announced publication of results from the BIOSCIENCE trial in the journal EuroIntervention. The study’s authors suggest that the Orsiro hybrid drug-eluting stent (DES) may have an advantage over Xience Prime/Xpedition in treating ST-segment elevation myocardial infarction (STEMI) patients. 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 included in the BIOSCIENCE trial revealed that Orsiro might be associated with better clinical outcomes than Xience Prime/Xpedition for this indication. At one year, BIOSCIENCE’s primary endpoint of target lesion failure (TLF) occurred in seven (3.3 percent) STEMI patients treated with Orsiro compared with 17 (8.7 percent) patients 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. Results from the multi-center, randomized, controlled non-inferiority trial were first published in The Lancet.

“During the BIOSCIENCE trial, Orsiro was associated with a significantly reduced risk of the primary endpoint of TLF for STEMI patients,” commented lead author Dr. Thomas Pilgrim, University Clinic for Cardiology, Bern, Switzerland. “We hypothesize this is due to Orsiro’s bioabsorbable polymer, which might provide favorable results on arterial healing after implantation. The effect of an enhanced healing response may be more pronounced in the inflammatory milieu of STEMI. As we currently have only limited data available on the clinical performance of newer generation DES in STEMI patients, we will soon attempt to extend these results in a dedicated randomized trial known as BIOSTEMI.”

“With these extremely promising results for the BIOSCIENCE trial’s STEMI patients in hand, it is now time to demonstrate Orsiro’s far-reaching capabilities with a much larger randomized, controlled trial specifically focused on this indication,” stated Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. “In an effort to shed light on the superb efficacy of Orsiro in this challenging patient population, we expect to begin enrolling patients to the BIOSTEMI trial soon.”

    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.