Nieuwe Promus Premier TM en Synergy TM DRUG-eluting stent systemen veiliger en effectiever

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Boston Scientific Corporation (NYSE: BSX) presenteerde eind mei de positieve resultaten van twee studies naar hun nieuwe, innovatieve drug-eluting stent (DES)-technologieën, voor de behandeling van coronaire hartziekten. Gegevens uit de eerste toepassing bij mensen in de  NG PROMUS Clinical Trial kan vooral de veiligheid en effectiviteit van de Promus PREMIERTM Everolimus-eluerende Platinum Chromium Coronary Stent System naar voren. De twee jaar follow-up gegevens van de EVOLVE Trial laten zien dat veiligheid en effectiviteit van het SYNERGY Everolimus- eluting Bioabsorbable Polymeer-Coated Platinum Chromium Coronaire Stent System veel beter zijn. Ook de PROMUS ElementTM Stent System werd gepresenteerd op de jaarlijkse EuroPCR Scientific Program in Parijs.

Deze positieve resultaten van twee klinische onderzoeken met nieuwe en innovatieve technologieën voor drug-eluting stents (Des)zijn hoopgevende opties in de behandeling van coronaire hartziekte. All’EuroPCR Scientific Program werden gepresenteerd in de klinische studiegegevens Ng Promus (eerste studie bij in vivo bij mensen) en de data follow-up van twee jaar van de studie Evolve. 525716-441x500Laatstgenoemde vergelijken de veiligheid en werkzaamheid van de coronaire stent Synergy (platform platina-chroom met een bio-absorbeerbare polymere coating vrijgave van everolimus).

De studie Ng PROMUS evalueerde de klinische en angiografische stent Promus Premier tot 30 dagen. John Ormiston, bij Mercy Angiografie, Auckland City, Nieuw-Zeeland, is de belangrijkste onderzoeker van de studie en presenteerde de gegevens op de conferentie. “De stent Promus Premier heeft aangetoond een uitstekende veiligheid en werkzaamheid bij 0% van het doel revascularisatie en stent trombose. Bovendien, was het technische succes, het primaire eindpunt van de studie  zeer hoog, 99,2%. Het is een zeer belangrijke stap voorwaarts in de stent-technologie. ”
“De Promus PREMIER Stent heeft bewezen uitstekende veiligheid en effectiviteit door nul procent doellaesie revascularisatie en stent trombose,” aldus Dr Ormiston. De Promus PREMIER Stent System is echt een grote stap voorwaarts in stent-technologie. ”
De Promus PREMIER Stent System is voorzien van aangepaste stent architectuur in die enig in zijn soort is voor de stevigheid, zonder afbreuk te doen aan flexibiliteit. Een verbeterde low-profile afgiftesysteem met een kortere, meer zichtbare topje, dual-layer ballon en Bi-SegmentTM inwendige lumen katheter is ontworpen om nauwkeurige stent levering in heel uitdagende laesies vergemakkelijken.

Vooral de longitudinale flexibiliteit is een groot voordeel zo stelt cardioloog van Geuns. Hiermee kan de stent heel mooi in de normale loop van het vat worden geplaatst en daardoor blijft de normale flow in tact en dat zie je terug in de studieresultaten: 0% target leasions. De stent zelf is makkelijker te buigen dan andere stents.
stent Promus Premier presenteert de unieke architectuur van de stent in zijn categorie volgens de specifieke inbreng van clinici. De Stent is voorzien van een verbeterd afgiftesysteem en is compact, wat korter en toegankelijk,

Synergie De stent is gemaakt van een combinatie van een biologisch absorbeerbaar polymeer PLGA en drug everolimus, teneinde een coating te maken met een lage initiële belasting, ultra-dun en uniform dat wordt aangebracht op het abluminale oppervlak (buitenste) van de stent. Het PLGA-polymeer, beschermd door octrooien volledige absorptie kort na het einde van de afgifte van het geneesmiddel drie maanden, waardoor er slechts een kale platina chroom stent. Deze technologie biedt dezelfde mate van beperking van restenose van de stent vrij te geven van everolimus traditionele en tegelijkertijd biedt een potentieel snellere genezing van de schepen en compleet na stentimplantatie. Dit zou de vereiste duur van dubbele antiplatelet therapie postoperatief verminderen.

“De Promus stent Premier Synergy en vertegenwoordigen de nieuwste aanbod in onze ‘pipeline’ van drug-eluting stents, verdere ontwikkeling ondergaan – zei Kevin Ballinger, voorzitter van interventionele cardiologie Boston Scientific – deze innovaties weerspiegelen onze toewijding aan interventionele cardiologen en hun patiënten. ”

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BOSTON SCIENTIFIC PROMUS PREMIER™ AND SYNERGY™ DRUG-ELUTING STENT SYSTEMS PROVIDE EXCEPTIONAL SAFETY AND EFFICACY DATA

Paris (May 22, 2013) ? Boston Scientific Corporation (NYSE:BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, and two-year follow-up data from the EVOLVE Trial comparing the safety and effectiveness of the SYNERGY Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent System to the PROMUS Element™ Stent System, were presented today at the annual EuroPCR Scientific Program in Paris.

The NG PROMUS Clinical Trial evaluated the clinical and angiographic outcomes for the Promus PREMIER Stent System at 30 days. John Ormiston, M.D., of Mercy Angiography, Auckland City, New Zealand is the primary investigator for the trial and presented data at the conference.
“The Promus PREMIER Stent demonstrated excellent safety and effectiveness with zero percent target lesion revascularization and stent thrombosis,” said Dr. Ormiston. “In addition, the rate of technical success, the primary endpoint of the trial, was very high at 99.2 percent. The Promus PREMIER Stent System truly is a major step forward in stent technology.”
The Promus PREMIER Stent System features the only customized stent architecture of its kind providing strength without compromising flexibility. An enhanced low-profile delivery system with a shorter, more visible tip, dual-layer balloon and Bi-Segment™ inner lumen catheter is designed to facilitate precise stent delivery across challenging lesions.
Two-year follow-up data from the EVOLVE Trial were also presented today at EuroPCR by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. The primary clinical and angiographic endpoints of this non-inferiority study, which compares the SYNERGY Stent to the PROMUS Element Stent, have already been published.
“The clinical results of the SYNERGY Stent in EVOLVE continue to impress with respect to safety and efficacy. At two years, we see no increase in the 1.1 percent target lesion revascularization (TLR) and zero percent stent thrombosis rates that we observed in the full-dose SYNERGY Stent at one year,” said Professor Meredith. “Interestingly, the difference in TLR between the PROMUS Element Stent at 6.1 percent and the SYNERGY Stent at 1.1 percent is approaching statistical significance (p=0.07). This is encouraging, as it supports our hypothesis that the bioabsorbable polymer coating could provide a long term benefit over durable polymer coated DES.”
The SYNERGY Stent features a bioabsorbable PLGA polymer and everolimus drug combination to create a low initial weight, ultra-thin, uniform coating that is applied to the abluminal (outer) surface of the stent. The proprietary PLGA polymer completes absorption shortly after drug elution ends at three months, leaving only a bare platinum chromium stent. This technology provides the same level of restenosis reduction as a conventional everolimus-eluting stent while potentially offering faster and more complete vessel healing after stent implantation, which could reduce the required duration of post-procedure dual antiplatelet therapy.
“The Promus PREMIER and SYNERGY Stent Systems are the latest additions to our growing pipeline of drug-eluting stent technologies,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “These innovations reflect our commitment to interventional cardiologists and the patients they serve.”
Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart. Recent statistics from the European Heart Network and the European Society of Cardiology show it is the single most common cause of death in Europe accounting for 1.8 million deaths in Europe per year. Patients living with coronary heart disease, also known as coronary artery disease, may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.
The Promus PREMIER and SYNERGY Stents have CE Mark approval. In the United States and Japan, they are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
About the NG PROMUS Clinical Trial
The NG PROMUS Clinical Trial supports the safety and efficacy of the Promus PREMIER Stent System.
About the EVOLVE Trial
EVOLVE is the first human use prospective, randomized, single-blind, study evaluating the non-inferiority of the SYNERGY Stent, which employs a bioabsorbable polymer coating applied to the abluminal (outer) surface of the stent, compared to the Boston Scientific PROMUS Element Stent, which utilizes a durable polymer coating applied to the entire stent (inner and outer) surface.
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About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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