BIOSTEMI Trial to Establish Orsiro's Enhanced Efficacy and Safety in Challenging Indication

Following Highly Promising Results of the BIOSCIENCE Trial, a New Study Aims to Demonstrate the Superiority of Orsiro in Treating ST-Segment Elevation Myocardial Infarction Patients / Vascular Intervention

Buelach, Switzerland, (PresseBox) - BIOTRONIK announced today the first patient enrolment in the BIOSTEMI trial. The randomized, controlled superiority trial is the first to directly compare the safety and efficacy of the Orsiro hybrid drug-eluting stent (DES) with Xience Xpedition in treating ST-segment elevation myocardial infarction (STEMI). 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.

“As we currently have limited data available on the clinical performance of newer generation DES in STEMI patients, the problem of optimal DES therapy in this challenging patient population remains unresolved,” commented principal investigator Dr. Juan F. Iglesias, Lausanne University Hospital (CHUV), Lausanne, Switzerland. “During the earlier BIOSCIENCE trial, Orsiro was associated with a reduced risk of the primary endpoint, target lesion failure (TLF), for a subgroup of 407 STEMI patients. Once we became aware of Orsiro’s potential benefit for such patients, the next logical step was to attempt to extend these results in a dedicated randomized trial.”

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 Xpedition DES. Results from the multi-center, randomized, controlled non-inferiority trial were first published in The Lancet. A subanalysis of 407 STEMI patients revealed that Orsiro was associated with better clinical outcomes than Xience Prime/Xpedition for this indication. At one year, BIOSCIENCE’s primary endpoint TLF occurred in just seven

(3.3 percent) STEMI patients treated with Orsiro compared with

17 (8.7 percent) patients treated with the durable polymer DES.

The investigator-initiated, international multi-center BIOSTEMI superiority trial is currently in the process of enrolling 1,250 patients at 16 study centers in Switzerland and Italy. STEMI patients will be randomized for treatment with either Orsiro or Xience Xpedition. BIOSTEMI’s primary endpoint is TLF at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization (CD-TLR). All patients will be followed for up to five years.

“Following the extremely promising results seen in the BIOSCIENCE trial’s STEMI subgroup, we intend to prove Orsiro’s far-reaching capabilities with a trial focused on this challenging indication,” stated Dr. Alexander Uhl, Vice President Marketing, Vascular Intervention at BIOTRONIK. “In addition, this trial represents an excellent opportunity to gather vitally important data on a complex patient population. We greatly look forward to the results.”

About Orsiro

The Orsiro Hybrid Drug-Eluting Stent (DES), launched in 2011,

features the latest development in BIOTRONIK stent technology – a unique hybrid solution that combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating system is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and exceptional deliverability.

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A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; Pulsar, the world's first 4 F compatible stent for treating long lesions; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

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