EuroPCR 2024: Late-Breaking Data Demonstrate Significant Clinical Advantage of Elixir Medical’s DynamX Bioadaptor Over Standard of Care Drug-Eluting Stent at Two Years
May 14 2024 - 9:15AM
Business Wire
—Statistically significant reduction in hard
clinical endpoints of TLF and TVF with DynamX; event rate flattened
after one year in bioadaptor versus non-plateauing increase in
DES—
—In Left Anterior Descending (LAD) artery,
bioadaptor demonstrated statistically significant 78% reduction in
target lesion failure versus DES—
Elixir Medical, a developer of transformative technologies to
treat cardiovascular and peripheral disease, today announced
two-year results from the BIOADAPTOR Randomized Controlled (1:1)
Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to
standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34
centers in Japan, Europe, and New Zealand. The results, for the
first time, demonstrate significant reduction in adverse events and
clinical advantage of the DynamX bioadaptor in target lesion
failure (TLF) and secondary endpoint of target vessel failure (TVF)
driven by sustained low event rates with DynamX compared to a
two-fold increase in DES. The data were presented at a
late-breaking clinical session during the EuroPCR 2024 conference
in Paris.
Clinical results show statistically significant benefit with
DynamX bioadaptor over Resolute Onyx at two years:
- 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046). The
significant reduction in TLF was driven by low adverse events
across all components of the composite endpoint with DynamX
compared to DES, respectively:
- Cardiovascular death (0% versus 1.8%)
- Target vessel myocardial infarction (0.9% versus 1.9)
- Target lesion revascularization (0.9% versus 2.3%)
- 68% reduction in TVF rate (1.9% versus 6.0%; p=0.029) in DynamX
compared to DES
Two-year lesion subset results:
- 78% reduction (1.9% vs.8.7%; p=0.028) in TLF rate in left
anterior descending (LAD) artery lesions treated with DynamX
bioadaptor versus treatment with DES
- Small vessels (<2.75mm) TLF rate was 0% vs. 3.5% in DynamX
versus DES, respectively
- Long lesions (>23mm) TLF rate was 0% vs. 2.3% in DynamX
versus DES, respectively
“These two-year results from the BIOADAPTOR RCT trial are very
exciting—unlike anything we’ve ever seen before—and represent a new
treatment category for patients living with coronary artery
disease. The TLF rate curve separation validates how the
bioadaptor’s unique design and mechanism of action restores the
vessel viability, including the LAD vessel. It does this by
restoring hemodynamic modulation validating the previously
demonstrated superior imaging outcomes at one year. These data show
that bioadaptor offers sustained, very low event rates across all
major endpoints, making it a superior option compared to DES,” said
Shigeru Saito, M.D., director of the Division of Cardiology and
Catheterization Laboratory at Shonan Kamakura General Hospital in
Kamakura, Japan. “The 78% magnitude of reduction in clinical events
in LAD lesions is particularly important, as the artery provides
50% of a heart muscle’s blood supply and undergoes significant
hemodynamic movement during every cardiac cycle. Restoring its
function is clearly of significant benefit.”
The DynamX bioadaptor is different from current standard of care
therapies, having a novel mechanism of action designed to return
vessel health through three distinct phases of adapting in the body
to restore vessel biology. The locked phase establishes maximum
flow lumen and restores blood flow. Unique to bioadaptor, the
unlocked and separation phase of bioadaptor’s helical strands
releases the vessel while maintaining the established blood flow
lumen. The final phase provides adaptive dynamic support after the
unlocking and separation phase to restore vessel hemodynamic
modulation through restoration of pulsatility and adaptive blood
flow volume and has shown evidence of plaque stabilization and
regression in the lesion.
“We are beyond thrilled with these findings from the BIOADAPTOR
RCT,” said Motasim Sirhan, CEO of Elixir Medical. “Never before
have we seen a vascular technology that addresses the limitations
of existing revascularization therapies by restoring artery
hemodynamic modulation and stabilizing or regressing plaque volume,
as we have with DynamX bioadaptor. These exceptional patient
clinical outcomes further validate that the bioadaptor is truly a
transformative technology for coronary artery disease
treatment.”
About BIOADAPTOR RCT Trial
The BIOADAPTOR RCT is an international, single-blind, randomized
controlled (1:1) trial (RCT) comparing a sirolimus-eluting
bioadaptor with a contemporary zotarolimus-eluting stent in 445
patients in 34 centers in Japan, Europe, and New Zealand. Both arms
had large randomized multi-modality imaging subgroups of 50
patients each to document standard effectiveness benchmarks of
establishing and maintaining artery flow lumen measured by percent
diameter stenosis (%DS) and late lumen loss (LLL), and the new
effectiveness benchmarks of restoring artery hemodynamic
modulation, including pulsatility, vessel compliance, adaptive flow
volume, and plaque stabilization and regression. Clinical follow-up
will continue through five years.
BIOADAPTOR RCT trial is the third trial of Elixir Medical’s
robust DynamX bioadaptor clinical evidence program consisting of
nine company-sponsored and investigator-initiated studies involving
over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and
a global BIO-RESTORE registry with a target enrollment of up to
5,000 patients.
About DynamX Coronary Bioadaptor System
The DynamX bioadaptor is the first coronary implant technology
designed to restore coronary artery hemodynamic modulation as
demonstrated by restored vessel pulsatility, compliance, and
adaptive increase in blood flow volume, and providing plaque
stabilization and regression. With its unique mechanism of action
(MOA), it addresses the shortcomings of drug-eluting stents and
bioresorbable scaffolds (BRS) with remarkably low clinical event
rates that showed a plateau between one-year and two-year clinical
follow up.
The DynamX Coronary Bioadaptor System is CE-marked. Not
available for sale in the U.S.
About Elixir Medical
Elixir Medical Corporation, a privately-held company based in
Milpitas, California, develops disruptive platforms to treat
coronary and peripheral artery disease. Our technologies have
multiple applications across the cardiovascular space capable of
delivering improved clinical outcomes for millions of patients.
Visit us at www.elixirmedical.com and on LinkedIn and X.
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Emma Yang, Health+Commerce Email: emma@healthandcommerce.com