STENTYS Self-Apposing Stent Featured Prominently at 2014 EuroPCR Conference
27 May 2014 - 4:00PM
Business Wire
- Over 20 case presentations
- 3 clinical trials in “Hotline” Late
Breaking sessions
- 2 dedicated symposia
STENTYS (FR0010949404 – STNT), a medical technology company
commercializing in Europe the world's first and only
Self-Apposing® Stent to treat acute myocardial
infarction (AMI), today reported on multiple sessions, symposia and
case presentations featuring STENTYS stents during the annual
EuroPCR meeting held in Paris last week.
- Late Breaking sessions: 3 Trials on
STENTYS Technology
1. APPOSITION IV: Sirolimus-eluting stent shows excellent
efficacy and faster healing
In the much anticipated final results from APPOSITION IV, the
sirolimus-eluting Self-Apposing stent (SES) demonstrated excellent
efficacy compared to market leading stents and faster healing
compared to balloon-expandable stents. With these results, the
STENTS SES could receive CE Mark as soon as the second half of this
year.
2. ADEPT: Self-Apposing stents are well suited for treatment of
diseased bypass grafts
Sander IJsselmuiden, M.D., Ph.D., of Albert Schweitzer Hospital
in the Netherlands presented 6-month results of ADEPT, a
prospective, multi-center, randomized, two arm clinical study that
enrolled 40 patients treated for a diseased coronary artery bypass
graft with either the STENTYS paclitaxel-eluting stent (PES) or the
STENTYS bare metal stent (BMS). Treatment with STENTYS
Self-Apposing stents in this setting was found safe and effective,
with late lumen loss in line with previous STENTYS trials in native
vessels. SVGs, a type of graft, can become diseased over time and
have uncertain diameters due to the presence of clots and debris,
thus increasing the risk of undersizing or oversizing with
conventional balloon-expandable stents. STENTYS Self Apposing
stents are designed to maintain continual apposition within the
vessel; the treatment of bypass graft narrowing was added to the
STENTYS CE certificate as an additional indication in 2013.
3. OPEN II: Data reinforce expanded use in indications beyond
STEMI
Christoph K. Naber, M.D., Ph.D., of Contilia Heart and Vascular
Center in Germany presented the 12-month results of the OPEN II
study, which enrolled 217 patients with coronary bifurcation
narrowing treated with the STENTYS PES, and a comparison at 9
months to the landmark BBC I trial. Despite a more severe
population, the STENTYS PES performed equally well with a MACE rate
of 12.6% vs 11.2% (p=0.63). Bifurcations, which are also part of
the CE certificate indications, account for 15% to 20% of all
coronary lesions treated by percutaneous coronary intervention
(PCI).
- Over 20 patient cases presented
throughout the conference
The EuroPCR organizers encourage cardiologists to share clinical
experience with their peers by way of patient case studies
presented during the congress. More than 20 patient cases featuring
a STENTYS stent were presented during the course of the week. The
technology was often highlighted as a valuable option to address
shortcomings of conventional stents.
“I was very impressed to see how my European colleagues have
incorporated the STENTYS stent as an integral part of their
treatment armamentarium,” commented Roxana Mehran, M.D., of Mount
Sinai in New York and a member of STENTYS’ Scientific Advisory
Board.
Gonzague Issenmann, Chief Executive Officer and co-founder of
STENTYS, said: “This year’s EuroPCR, one of the leading congresses
in interventional cardiology, has been our most successful to date.
The data presented continue to highlight the strength of STENTYS
Self-Apposing stents in a variety of clinical settings, and the
frequent, spontaneous mention of our stent in peer debates is a
clear sign that it is becoming an indispensable tool in today’s
cath lab.”
STENTYS is participating in French Life Sciences Days, on June
25-26, 2014 in New York.
About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing
dilemma that cardiologists are confronted with when treating heart
attack patients or patients with atypical artery anatomy. Its
flexible, self expanding design takes the shape of the patient’s
unique vessel anatomy and apposes to the irregular contours of a
blood vessel, in particular after an AMI as the vessel dilates and
the clot dissolves. It reduces the risk of malapposition and
complications associated with conventional stents in this setting.
The STENTYS Self-Apposing Stent has been marketed in Europe since
receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent
should receive the CE Mark during the second half of 2014.
About STENTYS
STENTYS is developing and commercializing innovative solutions
for the treatment of patients with acute myocardial infarction
(AMI, or heart attack) and complex coronary artery disease.
STENTYS’ Self-Apposing® Stents are designed to adapt to vessels
with ambiguous or fluctuating diameters, particularly in the
post-infarction phase, in order to prevent the malapposition
problems associated with conventional stents. In the APPOSITION III
clinical trial, STENTYS stents demonstrated a very low one year
mortality rate among 1,000 high-risk AMI patients when compared to
recent studies with conventional stents. More information is
available at www.stentys.com.
This press release contains forward looking statements about the
Company’s business. Such forward looking statements are based on
numerous assumptions regarding the Company’s present and future
business strategies and the environment in which it will operate in
the future which may not be accurate. Such forward-looking
statements involve known and unknown risks which may cause the
Company’s actual results, performance or achievements to differ
materially from any future results, performance or achievements
expressed or implied by such forward-looking statements. Such
factors include, among others, risks associated with the
development and commercialization of the Company’s products, market
acceptance of the Company’s products, its ability to manage growth,
the competitive environment in relation to its business area and
markets, its ability to enforce and protect its patents and
proprietary rights, uncertainties related to the U.S. FDA approval
process, including with respect to a pre-market approval for the
Company’s BMS, slower than expected rates of patient recruitment
for clinical trials, the outcome of clinical trials, and other
factors, including those described in the Section 4 “Risk Factors”
of the Company’s 2011 Registration Document (document de référence)
filed with the French Autorité des Marchés Financiers on August 27,
2013 under number R.13-040 as such section may be updated from time
to time.
STENTYSStanislas Piot, +33 (0)1 44 53 99
42CFOstan.p@stentys.comSTENTYS is listed on Comp. B of the NYSE
Euronext ParisISIN: FR0010949404 – Ticker:
STNTorNewCap.Financial Communication / Investor
RelationsDusan Oresansky / Pierre Laurent, +33 (0)1 44 71 94
93stentys@newcap.frorUS: MacDougall Biomedical
CommunicationsCharles Liles, 781-235-3060Christine Labaree or
Hunter Marshall, 650-339-7533stentys@macbiocom.com
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