Full IDE Data Set Demonstrates Statistically
Significant Reduction of All-Cause Mortality and Primary Major
Adverse Events (MAEs) at 30 days with use of AMDS in Acute DeBakey
Type I (ADTI) Dissections Complicated by Malperfusion
72% Reduction in All-Cause Mortality and 52%
Reduction in Primary Major MAEs when Compared to Current Standard
of Care Hemi-arch Procedure
ATLANTA, Jan. 29,
2024 /PRNewswire/ -- Artivion, Inc. (NYSE:
AORT), a leading cardiac and vascular surgery company focused
on aortic disease, today announced the presentation of results from
the AMDS PERSEVERE clinical trial in a Late-Breaking Science
presentation at the 60th Annual Meeting of the Society
of Thoracic Surgeons in San Antonio,
Texas. The data presented analyzed clinical outcomes across
the full 93 study participant IDE cohort at 30-days following AMDS
implantation.
Dr. Wilson Szeto, Chief of
Cardiovascular Surgery at Penn Presbyterian Medical Center,
presented the data from the PERSEVERE US IDE trial as a
late-breaking abstract titled, Results of a Novel Aortic Arch
Hybrid Prosthesis for Open Repair of Acute DeBakey Type I
Dissection with Malperfusion: 30-day Results from the PERSEVERE
Study.
Data from the trial demonstrate statistically significant
reduction of all-cause mortality and primary major adverse events
(MAEs), as well as no occurrence of distal anastomotic new entry
(DANE):
|
PERSERVERE
(%)
|
Historical
Reference1 (%)
|
Primary major adverse
events (³1 MAE)
|
28.0
|
58.0
|
All-cause
mortality
|
9.7
|
34.6
|
New disabling
stroke
|
11.8
|
20.9
|
New onset renal failure
requiring dialysis
|
19.4
|
24.1
|
Myocardial
infarction
|
0.0
|
10.5
|
Distal anastomotic new
entry (DANE)
|
0.0
|
45
|
The data also demonstrate excellent results for secondary
endpoints:
|
PERSEVERE
(%)
|
Technical
Success
|
98.9
|
Unanticipated aortic
reoperations
|
3.2
|
Distal stent-induced
new entry (d-SINE)
|
1.1
|
Occlusion of
Supra-aortic vessels
|
0.0
|
New Post-op Paraplegia
or Paraparesis1
|
0.0
|
1One event remains in adjudication
The data compares very favorably with expected rates of early
reintervention and DANE tears in this patient population. DANE
tears occur in up to 70% of patients following hemiarch repair
without AMDS, allowing continued blood flow into the false lumen
created by the dissection.2,3 The presence of DANE is
associated with enlargement of the aorta, reoperation, and
increased mortality. In contrast, DANE has not been detected
in any patients in the PERSEVERE study and it was not reported in
the DARTS study through 3 years of follow up of AMDS-treated
patients.4
Dr. Szeto said, "Acute DeBakey Type I (ADTI) dissections remain
one of the most life-threatening emergencies that cardiac surgeons
address. Despite the seriousness of the condition, there have been
limited surgical advancements in the last several decades,
demonstrating an unequivocal need for innovation to better treat
these patients. I am extremely encouraged by the results of the
PERSEVERE study which indicate that AMDS significantly reduces
30-day MAE's in ADTI patients complicated by malperfusion and helps
prevent DANE. The ease of use and approachability of the AMDS
device will expand the ability of cardiac surgeons to offer a more
comprehensive treatment for these patients amidst a
life-threatening emergency."
"We are extremely excited to share these overwhelmingly positive
results from the PERSEVERE study as they reinforce the unrivaled
clinical benefit and life-saving nature of AMDS. Notably, these
results show an even greater improvement in all-cause mortality
compared to interim data presented in October," said Pat Mackin, Chairman, President, and Chief
Executive Officer of Artivion. "We now look forward to quickly
completing patient follow up and our PMA submission for AMDS to the
FDA and to delivering this revolutionary technology to patients
with no comparable alternatives as soon as possible."
About the AMDS PERSERVE Clinical Trial
The PERSEVERE trial is a prospective, multicenter,
non-randomized clinical trial to determine if patients with acute
DeBakey Type I aortic dissection can be treated safely and
effectively using the AMDS Hybrid Prosthesis. The trial is designed
to support the company's forthcoming application to the U.S. Food
and Drug Administration (FDA) for premarket approval of the AMDS.
The trial consists of 93 participants in the U.S., who have
experienced an acute DeBakey Type I aortic dissection. Each
participant will be followed for up to 5 years. The combined 30-day
safety and primary efficacy endpoints will determine the impact of
the AMDS Hybrid Prosthesis on DANE prevention, reducing mortality,
new disabling stroke, new onset renal failure requiring dialysis,
and myocardial infarction; as well as remodeling of the aorta.
About the AMDS Hybrid Prosthesis and DeBakey Type I Aortic
Dissections
The AMDS is the world's first aortic arch remodeling device for
use in the treatment of acute Type I aortic dissections. It is used
as a complement to, and in conjunction with, hemiarch replacement
without adding technical complexity. The design of the AMDS allows
for rapid deployment of the graft in the aortic arch during a
standard replacement of the ascending aorta, with deployment adding
minimal time to the procedure. The deployment of the AMDS preserves
the native arch, allowing for minimally invasive re-interventions
if needed, rather than an invasive arch repair. AMDS is available
in select markets around the world including Europe, Canada and certain countries in Asia. In the clinical trial (DARTS) supporting
the CE Mark and Health Canada approvals, the AMDS was shown to
reduce complications and reoperations in comparison to published
rates with the standard of care, thereby improving the care of
patients and offering potential cost savings for the health care
system.
Globally, approximately 48,000 patients suffer from acute
Stanford Type A aortic dissections annually, an estimated
$540 million market opportunity
pending regulatory approvals. Aortic dissection occurs when the
innermost layer of the aorta tears and blood surges through the
tear separating the layers of the aorta. In acute DeBakey Type I
aortic dissections, a subset of Type A dissections, the dissection
flap originates in the ascending aorta and continues down into the
descending thoracic aorta. Left untreated, aortic dissections lead
to death in about half of patients within the first 3 days. The
current standard of care for repairing acute DeBakey Type I aortic
dissections with a primary entry tear in the ascending is a
hemiarch repair which involves open chest surgery during which the
ascending thoracic aorta is replaced. Though this typically
addresses the most critical and pressing issues resulting from
acute DeBakey Type I dissections, it is often not enough. Hemiarch
repair alone does not address downstream true lumen expansion or
treating the false lumen beyond the ascending aorta, which could
lead to costly and fatal complications such as malperfusion with
subsequent end-organ ischemia resulting from a lack of blood-flow,
and continued pulsatile blood flow in the false lumen leading to
aneurysmal growth of the aorta.
About Artivion, Inc.
Headquartered in suburban Atlanta,
Georgia, Artivion, Inc. is a medical device company focused
on developing simple, elegant solutions that address cardiac and
vascular surgeons' most difficult challenges in treating patients
with aortic diseases. Artivion's four major groups of products
include: aortic stent grafts, surgical sealants, On-X mechanical
heart valves, and implantable cardiac and vascular human tissues.
Artivion markets and sells products in more than 100 countries
worldwide. For additional information about Artivion, visit our
website, www.artivion.com.
References
- Zindovic I et al. J Thorac Cardiovasc Surg 2019; Pacini D et
al. Eur J Cardiothorac Surg 2013; Girdauskas E. et al. J Thorac
Cardiovasc Surg 2009; Geirsson A. et al J Thorac Cardiovasc Surg
2007; Bossone E. et al Am J Cardiol 2002
- Ravesh M. et al. J Thorac Dis 2021
- Bing F et al. Vasc Endovasc Surg 2014, Ergin M, et al Ann
Thorac Surg 1994, Rylski B et al. Eur J Cardiothorac Surg, 2017,
Tamura K et al, Eur J Cardiothorac Surg 2017
- Reference: Bozso et al: The Journal of Thoracic and
Cardiovascular Surgery (2022), doi:
https://doi.org/10.1016/j.jtcvs.2022.08.040
Artivion
|
Gilmartin Group
LLC
|
Lance Berry
|
Brian Johnston / Laine
Morgan
|
Executive Vice
President &
|
Phone:
332-895-3222
|
Chief Financial
Officer
|
investors@artivion.com
|
Phone:
770-419-3355
|
|
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/artivion-announces-presentation-of-late-breaking-data-from-amds-persevere-trial-at-the-60th-society-of-thoracic-surgery-annual-meeting-302046209.html
SOURCE Artivion, Inc.