Sorin Group Announces Excellent 6-Month Interim Clinical Results Of JANUS Drug-Eluting Stent JUPITER II Trial
MILAN and PARIS, May 27 /PRNewswire-FirstCall/ -- - JUPITER II 6-Month Interim Clinical Data Provide Strong Indication of an Excellent Clinical Efficacy and an Unprecedented Safety Profile for the JANUS Tacrolimus-Eluting Carbostent.
Sorin Group, Europe's largest medical technology player specialized in the treatment of cardiovascular disease, announced today interim six-month clinical analysis results from its JUPITER II clinical trial. Marie-Claude Morice, M.D. (Massy, France), the Principal Investigator of the JUPITER II trial, made today an appealing presentation at the annual Paris Course on Revascularization (EuroPCR), the largest interventional cardiology conference in Europe.
JUPITER II is an international multi-center, double blind, randomized clinical trial designed to evaluate the safety and efficacy of JANUS Tacrolimus-eluting Carbostent in the treatment of coronary lesions in "direct stenting" procedures as compared to TECNIC Carbostent. A total of 332 patients were enrolled in 16 European centers and randomized to either JANUS (166 patients) or TECNIC (166 patients). Enrolment was completed on December 20, 2004.
Excellent Clinical Efficacy and unprecedented Safety from interim six-month outcome
The interim six-month clinical data that are available as of today for the statistical analysis (102 patients in group A and 88 patients in group B) clearly highlight strong clinical efficacy.
The study reported an 11.8% of Major Adverse Cardiac Events (MACE) rate in group A, compared with 3.4% in group B, and a Target Lesion Revascularization (TLR) rate of 11.8% in group A versus 3.4% in group B.
The MACE rate in both groups consisted only of TLRs. TLR is defined as the need for a repeat intervention (Percutaneous Transluminal Coronary Angioplasty - PTCA, or Coronary Artery Bypass Grafting - CABG) at the site of the target lesion due to the recurrence of symptoms, and is one of the best indicators of the performance of the drug-eluting stent system.
Outstanding results were presented on the safety profile. In particular, an unprecedented 0% thrombosis rate, both sub-acute (within 30 days from the procedure) and long-term, has been reported for both JANUS and TECNIC.
"The six-month angiographic follow-ups are well underway, and I am very pleased with the current clinical and safety profile demonstrated in these interim six-month clinical data," commented Dr. Marie-Claude Morice.
Further disclosure of the six-month clinical data is planned at the ESC congress in Stockholm in September, and the complete six-month clinical and angiographic outcome will be presented during the TCT congress in Washington in October.
"The study results seen so far confirm the basic assumptions on which JANUS innovative stent project was developed, namely the haemo-compatibility of the surfaces and the targeted drug release," said in his presentation Prof. Antonio Bartorelli (Milan), chairing the independent Data Safety Monitoring Board and the Critical Events Committee of the study.
"The interim results of Jupiter II show an excellent clinical outcome and safety profile for the JANUS polymer-free drug-eluting stent technology, as demonstrated by the low TLR and MACE rates and by the impressive 0% sub-acute and late thrombosis rate reported in both groups. It is a very exciting time for Sorin Group: we are very pleased with the results of our drug-eluting stent platform," added Greg Cash, President of Sorin Group's Vascular Therapy Business Unit.
About JANUS Tacrolimus-eluting Carbostent
JANUS represents a breakthrough in drug-eluting stents. Compared to other drug-eluting stents, JANUS has the following key benefits:
- JANUS requires no polymer matrix to carry the drug (Tacrolimus, a cytostatic drug also known as FK506, produced by Fujisawa - now 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.
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. The companies of the Sorin Group are: Bellco, CarboMedics, COBE Cardiovascular, Dideco, ELA Medical, Mitroflow, Soludia, Sorin Biomedica and Stockert. Sorin Group has about 4,800 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: http://www.sorin.com/Sorin Group
CONTACT: Marilena Giavara, Director, Corporate Communications & InvestorRelations, Tel. +39-02-6332201, e-mail:email@example.com; Laura Villa, Investor RelationsManager, Tel. +39-02-6332316, e-mail: firstname.lastname@example.org