PARIS, May 18, 2011 /PRNewswire/ -- One-year results from the 278-patient multi-center, prospective, single-arm study conducted at 16 sites in Europe and Israel were presented today at the EuroPCR 2011 Congress in Paris. These results reinforce the exceptional outcomes observed with the "Next Generation" PRESILLION(TM) Plus (PioNIR(TM)) cobalt chromium bare metal stent systems at 9-month follow-up, which was the primary endpoint of the PioNIR(TM) study.
The PRESILLION Plus features important technological advances designed to help restore the artery's natural form, support it to minimize the probability of restenosis and ensure easier access to distal lesions.
The data were presented by Dr. Stefan Hoffmann, Vivantes Klinikum im Friedrichshain, Berlin, Germany, during the EuroPCR session on registries of new generation bare metal stents.
Target Lesion Revascularization (TLR) at one year was 6.3% and Target Vessel Revascularization (TVR) was 8.1% at one year post procedure. A total of 278 patients were enrolled with a mean age of 65.5 years, 20.5% were diabetic, 27.8% had a history of MI, and 36.2% had a history of previous percutaneous coronary intervention. Device success was achieved in 98.2% of patients. The primary endpoint of TVF defined as cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) within 270 days post procedure was 8.9% at 9 months, substantially less than the 16.46% performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. Target vessel MI was 3.3% at one year post procedure. The overall rate of stent thrombosis was 0.7% at discharge and 1.1% up to one year post procedure. There was no stent thrombosis observed after 30 days. The PIONIR study was conducted to support a PMA in the US.
Dr. Hoffmann :" Presillion Plus is a new generation BMS with unique design and engineering capacities allowing good deliverability, vessel conformability and superior scaffolding."
PRESILLION(TM) Plus is the only stent in the market with an adaptive closed cell design that is capable of differential cell lengthening. This enables the stent to be flexible in the unexpanded configuration, and optimally support the vessel while conforming to the natural curve of the vessel in the expanded configuration.
"The unique geometry of the Presillion(tm) combines alternating rings optimizing both the flexibility and conformability on one hand, with continuous scaffolding on the other, like no other stent in the market. The new delivery system includes a hypo-tube for improved pushability in crossing calcified and other "stubborn" lesions and a redesigned semi-compliant balloon for precise stent deployment, higher rated burst pressure and decreased deflation time" says Dr. Kobi Richter, chairman of the board and Chief Technology Officer for Medinol.
The outstanding results of the PioNIR(TM) study may widen the domain of BMS use and suggest a more cost effective use of BMS in borderline cases, without the risk of thrombosis or extended dual anti-platelet therapy.
The PRESILLION(TM) Plus stent is approved in more than 100 countries worldwide.
The product is not yet available in the US market and is pending PMA approval.
The Presillion and Presillion Plus stent systems are designed developed and manufactured by Medinol Ltd, Israel. Medinol is a stent innovation company that develops both stents and delivery systems through design innovation and advanced manufacturing technologies.
PioNIR(TM) is a trademarks of Medinol Ltd.
PRESILLION(TM) /PRESILLION(TM) Plus are trademarks of Cordis Corporation.
Cordis Corporation a Johnson & Johnson company signed an exclusive distribution agreement with Medinol in 2008 and is distributing the PRESILLION(TM) Plus CoCr Coronary Stent on Rx System in Europe.
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SOURCE Medinol Ltd