Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting.
Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported.
In the 268-patient group treated with Orsiro, 60-month data from Bioflow-II showed a target lesion failure rate of 10.4%, compared to 12.7% in the group that received Abbott‘s (NYSE:ABT) Xience device. After five years, no definite or probable stent thrombosis occurred in the Orsiro group. In the 132-patient group treated with Xience, there was one case of very late definite thrombosis after five years.
Data from the Bioflow-III registry demonstrated a target lesion failure rate of 9.3% in a 1,356-patient cohort at 60 months. Definite or probable stent thrombosis occurred in eight cases, Biotronik reported.
“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,” investigator Dr. Ton Slagboom said in prepared remarks.
“Long-term data is critical to the clinical community,” Alexander Uhl, VP of marketing for Biotronik’s vascular intervention business, added. “We are delighted to be able to report these excellent long-term results, confirming that Orsiro can be considered the new benchmark for DES.”
