May 23, 2011 - 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 outcomes observed with the "Next Generation" Presillon Plus (PioNIR) cobalt chromium bare metal stent systems at 9-month followup, which was the primary endpoint of the PioNIR study.
The Presillon 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 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 United States.
Presillon Plus is the only stent on 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 Presillon Plus stent is approved in more than 100 countries worldwide.
The product is not yet available in the U.S. market and is pending PMA approval.