Sorin Group (MIL:SRN) (ISIN:IT0003544431):
-- SORIN GROUP releases results of Janus in real world AMI
patients: 6.3% MACE rate, 4.6% TLR rate and, more importantly,
0% of late stent thrombosis rate, which reinforces the
excellent safety profile of the thromboresistant Janus
platform.
Sorin Group, Europe's largest medical technology company
specialising in the treatment of cardiovascular diseases, presented
last week during the annual Paris Course on Revascularization
(EuroPCR), six-month clinical results from its e-Janus international
"real-world" registry, providing additional clinical evidence of the
strong benefits of the Janus Tacrolimus-eluting Carbostent in the
high-risk subgroup of patients with Acute Myocardial Infarction.
e-Janus is a multicenter, prospective registry, designed to
collect "real-world" clinical outcomes in more than 4000 patients with
coronary artery disease at more than 100 centers worldwide (except US
and Japan). e-Janus is based on electronic CRFs, with a 3% site
monitoring and with an independent CEC (Clinical Events Committee)
reviewing and adjudicating adverse events.
In the overall population who had completed the six-month
follow-up, 28.4% were diabetic patients, 50.4% were patients with
multivessel disease and 23% percent of patients presented with an AMI.
Dr. Koolen highlighted the outstanding results achieved in the 238 AMI
patients subset, with a 6.3% MACE rate at six-month follow-up, TLR
rate of 4.6% and, more importantly, a late stent thrombosis rate of
0%, reinforcing the excellent safety profile of the thromboresistant
Janus platform.
"Real practice results are increasing their importance and we are
glad to see that amongst the "real-world" AMI patients - who are the
most burdensome - Janus shows to be very safe and effective",
commented Stefano Di Lullo President of Sorin Group's Vascular Therapy
Business Unit.
About Janus stent
Sorin's first-generation drug-eluting stent system, the Janus
Tacrolimus-eluting Carbostent system, represents a breakthrough in
drug-eluting stents. Compared to other drug-eluting stents, JANUS has
the following key benefits:
-- JANUS requires no polymer to carry the drug (Tacrolimus, a
cytostatic drug also known as FK506, produced by Astellas),
eliminating the shortcomings often associated with polymers;
-- JANUS utilizes a proprietary drug-release system with
reservoirs on the stent's outer surface, ensuring targeted
release only towards the vessel wall segment requiring
treatment;
-- JANUS virtually eliminates the risk of thrombosis with its
proven and highly bio- and haemo-compatible Carbofilm(TM)
coating technology;
-- JANUS facilitates direct stenting, avoiding the need for
predilatation, thus reducing the overall cost of the
procedure.
About Sorin Group
Sorin Group (Reuters code: SORN.MI), a world leader in the
development of medical technologies for cardiac surgery, offers
innovative therapies for cardiac rhythm dysfunctions, interventional
cardiology and the treatment of chronic kidney diseases. Sorin Group
includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert,
Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin
Group has more than 4,700 employees working at facilities in more than
80 countries throughout the world to serve over 5,000 public and
private treatment centers.
For additional information, please visit our website:
www.sorin.com
