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TCT 2017: BIOTRONIK's Orsiro Drug-Eluting Stent Shows Low Five-Year Event Rates in BIOFLOW-II RCT and BIOFLOW-III Registry

Vascular Intervention / Five-Year Results Demonstrate High Long-Term Safety and Clinical Performance of Ultrathin Orsiro DES

(PresseBox) (Berlin, ) DENVER, United States and BUELACH, Switzerland, November 2, 2017 - BIOTRONIK's Orsiro1 drug-eluting stent (DES) demonstrated high long-term safety and clinical performance according to 60-month follow-up data presented during TCT 2017.

Data from the BIOFLOW-II randomized controlled trial was presented in a poster session by Dr. Ton Slagboom, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands, showing a target leisure failure (TLF) rate of 10.4 percent in the Orsiro group and 12.7 percent in the Xience2 study arm at 60 months (p=0.4728). No definite or probable stent thrombosis occurred during 60 months of follow-up in the Orsiro group (n=268). In the Xience group (n=132), one case of very late definite thrombosis was detected (0.7 percent) at five years.

In addition, data from BIOFLOW-III, a prospective, non-randomized, open-label, all-comers registry was presented in a poster session by Dr. Johannes Waltenberger, professor of cardiology and angiology at University Hospital Münster, Germany. Of an initially enrolled population of 1,356 patients, 898 patients consented for long-term follow up. Among these patients, there was a follow-up compliance of 90 percent at 60 months. The TLF rate of the full cohort was 9.3 percent at 60 months and definite or probable stent thrombosis occurred in eight cases (0.7 percent, including two very late stent thromboses).

Long-term data for both trials demonstrate that the previously observed low TLF rates at 12 months persisted through the 60-month follow-up. Rates of definite and probable stent thrombosis remained low through 60 months, affirming the safety of the Orsiro stent system in the long term.

"In choosing a permanent implant, clinicians must always consider the long-term impact of their choices; with this data Orsiro joins the limited number of DES with proven favorable outcomes out to five years," commented Dr. Slagboom, an investigator in the BIOFLOW-II trial.

The new data presented at TCT 2017 supplements the existing body of evidence supporting the use of the Orsiro DES, with over 32,500 patients enrolled to date in the Orsiro clinical program. This includes the recently reported BIOFLOW-V study data, which showed significantly lower 12-month TLF rates compared to Xience.

"Long-term data is critical to the clinical community," commented Dr. Alexander Uhl, BIOTRONIK Vice President of Marketing, Vascular Intervention. "We are delighted to be able to report these excellent long-term results, confirming that Orsiro can be considered the new benchmark for DES."

1 CAUTION – Investigational device in the United States. Limited by US law to investigational use.
2 Xience is a registered trademark of Abbott Cardiovascular Systems.
3 Not currently available in the United States.

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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 Magmaris3, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar-18, the world's first 4F compatible stent for treating long lesions; Orsiro, the ultrathin 60 micron drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.