MILAN, Italy and STOCKHOLM, Sweden, September 6 /PRNewswire-FirstCall/ --
- The Release of the Complete JUPITER II 6-month Clinical Data Confirms Excellent Clinical Efficacy and Safety Profile for the JANUS Tacrolimus-Eluting Carbostent
Sorin Group, Europe’s largest medical technology player specialized in the treatment of cardiovascular disease, released today the complete 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 a successful presentation at the annual European Society of Cardiology (ESC).
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 and performed with Direct stenting in 86.1% of procedures for Tecnic group and in 75.9% of procedures for JANUS group.
Excellent Clinical Efficacy and Safety from strong six-month clinical outcomes
The complete six-month clinical data (160 patients in Tecnic group and 157 patients in JANUS group ) clearly highlight strong clinical efficacy and safety.
The study reported stent related MACE of 10.6% (17 TLR out of 160 patients) for the control Tecnic group and a more favourable rate of 6.4% (9 TLR and 1 AMI out of 157 patients) for JANUS group.
The 6 month clinical efficacy of JANUS stent is expressed by a reduction of 46% of TLR in respect to Tecnic stent (TLR of 5.7% with JANUS versus 10.6% with Tecnic).
The occurrence of MACE in Jupiter II study is mainly related to TLR, the incidence of events such as death, AMI or CABG is negligible. 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.
The JANUS stent also exhibits the highest level of safety, as demonstrated with a rate of 0% of sub-acute and late stent thrombosis both in the JANUS group and in the Tecnic group, confirming previous clinical results with Tecnic and other Carbofilm coated stents.
“These complete six-month clinical results of Jupiter II demonstrate the excellent clinical outcome and unprecedented safety profile for the JANUS polymer-free drug-eluting stent technology, as demonstrated by the low MACE rate with JANUS and a reduction of TLR of 46% versus Tecnic. Analysis of the angiographic follow-up data is almost completed and I will be delighted to present them at TCT in Washington " commented Dr. Marie-Claude Morice.
Previous disclosure of the six-month interim clinical data occurred at the EuroPCR congress in Paris in May, and the complete six-month clinical and angiographic outcome will be presented during the TCT congress in Washington in October.
“The complete 6-month clinical results of Jupiter II demonstrate the excellent clinical outcome and safety profile for the JANUS polymer-free drug-eluting stent technology, as demonstrated by the low MACE rate with JANUS and a reduction of TLR of 46% versus Tecnic. These clinical outcomes are clearly competitive versus other DES currently marketed. The 0% stent thrombosis rate for both platforms is also impressive. We look forward to sharing the final angiographic data at TCT in October. It is a very exciting time for Sorin Group and we are extremely 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 whatsoever 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 CarbofilmTM 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 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: www.sorin.com
Sorin Group
CONTACT: Marilena Giavara, Director, Corporate Communications & InvestorRelations,Tel. +39-02-6332201, e-mail: marilena.giavara@sorin.com. LauraVilla, Investor Relations Manager, Tel. +39-02-6332316, e-mail:laura.villa@sorin.com
