Medinol and Gore Report NIRTOP Clinical Trial Results.Business Editors/Health/Medical Writers PARIS--(BUSINESS WIRE)--May 23, 2003 W. L. Gore & Associates Inc. (Gore) and Medinol, Ltd. reported the results of the NIRTOP clinical study conducted by Medinol, Ltd. The NIRTOP study was an international multi-center, prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. two-armed controlled study. The multi-centered trial was conducted in 15 sites worldwide and included 305 patients. Medinol, Ltd. reports the results of the NIRTOP trial confirm the clinical superiority of the NIRFLEX(TM) Stent. First, the stent has the lowest late loss rate of 0.65 mm -- a figure lower than any other bare metal 1. bare metal - New computer hardware, unadorned with such snares and delusions as an operating system, an HLL, or even assembler. Commonly used in the phrase "programming on the bare metal", which refers to the arduous work of bit bashing needed to create these basic tools stent. Average reference vessel diameter in the study was 2.74 mm (2.5 - 4.0). Second, the target lesion target lesion Dermatology A lesion typical of erythema multiforme–EM in which a vesicle is surrounded by an often hemorrhagic maculopapule; EM is often self-limited, of acute onset, resolves in 3-6 wks, and has a cyclical pattern; EM lesions are 'multiform' revascularization (TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) ) rate was in the single digit range -- 4.4% at 180 days, 7% at 210 days, and 8.9% at 270 days. Third, the NIRFLEX(TM) Stent showed an outstanding rate of restenosis of 6.3% in the frequently treated lesions in vessels greater than 3 mm. In addition, sub-acute thrombosis and late thrombosis were 0%, demonstrating the superb biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. of the stent surface, and the outstanding scaffolding properties of the stent design. These results position the NIRFLEX(TM) Stent as the best performing bare metal stent in the marketplace, and closer in clinical effect to the CYPHER See cipher. (R) Stent than to the BX VELOCITY(R) Stent. Antonio Colombo, M.D., (Columbus Hospital / San Raffaele Hospital The San Raffaele Hospital (HSR) is a university hospital situated in Milan, Italy. It was founded in 1969 by don Luigi Maria Verzé, president of "San Raffaele del Monte Tabor Foundation". , Milan, Italy), Principal Investigator of the NIRTOP clinical study, stated: "The NIRFLEX(TM) Stent, the subject of the NIRTOP(TM) randomized trial, proved to be everything we expected from Medinol as a leading innovator of coronary stents. The long-term clinical and angiographic results compare better than those of any other bare metal stents studied, and confirms the superiority of the NIRFLEX(TM) Stent achieved by its outstanding combination of scaffolding and conformability con·form·a·ble adj. 1. Corresponding; similar: plans that are conformable to your wishes. 2. Quick to comply; submissive. 3. ." Complete results of the NIRTOP trial were presented this week during the Medinol/Gore symposium titled "Advanced Coronary Stents and Pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. for Restenosis" at EuroPCR in Paris, France. ABOUT W. L. GORE & ASSOCIATES, INC. Gore is a leading manufacturer of thousands of advanced technology products for the electronics, industrial, fabrics and medical markets. The Gore Medical Products Division provides creative healing solutions to complex medical problems. Gore Medical provides such products as synthetic vascular grafts, interventional devices, surgical meshes for hernia repair Hernia Repair Definition Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position. , and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. With over 7.5 million implants, these devices have been saving and improving the quality of lives worldwide for the past 26 years. To learn more, visit www.goremedical.com. ABOUT MEDINOL, LTD. Medinol, Ltd. is a global leader in the field of stents and stenting systems with a vast and most significant portfolio of intellectual property. Medinol has developed a unique approach to the design and manufacture of an extensive product pipeline. Its new generation stents reflect the company's uncompromising commitment to continuous innovation, unique product design and top quality products. Medinol is privately held and headquartered in Tel Aviv, Israel. Additional information is available at www.Medinol.com. MEDINOL(R) and NIRFLEX(TM) are trademarks of Medinol, Ltd., Israel. GORE(TM) is a trademark of W. L. Gore & Associates. BX VELOCITY(R) and CYPHER(R) are trademarks of Cordis Corporation. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion