Medtronic: Shows Exceptional Safety, Efficacy Outcomes for Stent

Investigators today unveiled new
clinical data from the physician-initiated BIONYX study, representing the first
all-comers analysis in nearly 2,500 patients comparing the safety and efficacy
of the durable polymer Resolute Onyx(TM) drug-eluting stent (DP-DES) from
Medtronic plc (NYSE: MDT) to the Orsiro biodegradable polymer stent (BP-DES). At
one year, the study showed patients with coronary artery disease who were
treated with Orsiro BP-DES received no clinical advantage compared to patients
treated with the Resolute Onyx DP-DES, and Orsiro BP-DES demonstrated a higher
rate of stent thrombosis.(1) Published simultaneously in The Lancet, the results
were presented today during a Late-Breaking Clinical Trial session at the 30th
Transcatheter Cardiovascular Therapeutics conference (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation.

Enrolling approximately 2,500 real-world patients (71 percent with acute
coronary syndrome), the BIONYX study had a primary composite endpoint of target
vessel failure (TVF) at one-year and showed no statistically significant
difference in outcomes for the Resolute Onyx DP-DES treated group (N=1,243) at
4.5 percent compared to 4.7 percent with the Orsiro BP-DES. However, notable
differences were observed in significantly lower rates of definite or probable
stent thrombosis (0.1 percent for Resolute Onyx compared to 0.7 percent with
Orsiro DES) at one year (p = 0.01).

https://www.marketscreener.com/MEDTRONIC-PLC-20661655/news/Medtronic-Late-Breaking-Clinical-Study-Results-Demonstrate-Exceptional-Safety-and-Efficacy-Outcome-27302490/