Late-Breaking Clinical Study Results Demonstrate Exceptional Safety and Efficacy Outcomes for Resolute Onyx(TM) DES
September 22 2018 - 1:41PM
TCT18: BIONYX
Study Shows Strong Performance with Durable Polymer Resolute Onyx
DES in Head-to-Head Comparison with Biodegradable Polymer
DES
DUBLIN and SAN DIEGO - September
22, 2018 - 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).
"Never before has a head-to-head stent trial
assessed the new-generation durable polymer zotarolimus-eluting
stent - the Resolute Onyx DES - which has thinner struts and
improved visibility compared to its predecessor, the Resolute
Integrity DES," said Prof. Clemens von Birgelen, M.D. Ph.D.,
co-director of the Department of Cardiology at Thoraxcentrum
Twente, Professor of Cardiology at University of Twente in
Enscheded, the Netherlands, principal investigator of the trial and
presenter of the data at TCT. "The Resolute Onyx demonstrated
excellent safety and efficacy that matched at one-year the results
of a biodegradable polymer sirolimus-eluting stent with ultra-thin
struts that showed excellent outcomes in previous head-to-head
stent studies. The stent thrombosis data are promising, but should
not be overestimated as we cannot exclude a play of chance."
The Resolute Onyx DES is coated with the
proprietary BioLinx(TM)polymer, a bio-compatible and
non-thrombogenic coating specifically designed for use on DES. Low
rates of stent thrombosis have been observed in more than 70,000
real-world clinical study patients, with additional studies
underway, including the global Medtronic Onyx ONE Month DAPT
Program comprised of two studies designed to investigate safety
following one-month of dual anti-platelet therapy (DAPT)
discontinuation post-PCI. The Resolute Onyx DES offers the broadest
size matrix available and is the first-and-only DES to feature Core
Wire Technology which enables thinner struts and greater
deliverability while maintaining structural strength and enhanced
visibility.
"We have yet to see any meaningful clinical
benefit with the introduction of biodegradable stent technologies,"
said Dave Moeller, vice president and general manager of the
Coronary and Renal Denervation business, which is part of the
Cardiac and Vascular Group at Medtronic. "The Resolute Onyx DES has
been shown to deliver excellent outcomes for a wide range of
patients, and we are pleased to see that the combination of
visibility, thin struts, conformability, and biocompatibility
resulted in a very low stent thrombosis rate in this study."
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 86,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
1 Stent
thrombosis was not a powered endpoint in the BIONYX
Study.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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