Antonio colombo is director of interventional cardiology at san raffaele hospital and colombus hospital in milan, italy. The promus premier stent system is currently offered in a matrix of 47 sizes, ranging in diameter from 2. Allergic reactions after drug eluting stent des hypersensitivity tweet post to this topic if you are concerned that you may be experiencing an allergic reaction hypersensitivity after a drugeluting stent des procedure. Boston scientific receives fda approval for promus premier. Antonio colombos perspective on the promus premier stent boston scientific cardiology. The promus element plus everolimuseluting chromium platinum coronary stent, a stent used in europe that has been implicated in the longitudinal strength debate.
Promus element plus monorail everolimuseluting coronary stent system is a medical device used to treat patients who have coronary artery disease. Boston sci promus premier drug eluting stent now available. Objectives to compare susceptibility of five different stent platforms with longitudinal stent deformation lsd using a clinically relevant bench testing model simulating both short and long malapposed lengths. Clinical utility of platinum chromium baremetal stents in. Perhaps the most impressive benefit of the promus premier stent system is its unparalleled visibility, which combined with enhanced customized stent architecture, leads to an advance in currently available durable polymer des, said leon, in a boston scientific press release. Contents for 1 promus element plus monorail stent systemone 1 promus element plus monorail stent system two 2 clipittm coil clips one 1 flushing needle with luer fitting 2. Although longitudinal stent deformation probably occurs with all stents, in recent years the majority of clinical reports of the problem have been with the element stent. There is a proximal 70% stenosis in the native lad proximal at the stent.
Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. The promus element platinum chromium stent met the primary noninferiority endpoint of target lesion failure at one year compared to the promus stent, while demonstrating excellent safety and effectiveness with low rates of cardiac death, myocardial infarction, stent thrombosis and. Boston scientific promus premier and synergy drugeluting stent systems provide exceptional safety and efficacy data. Thus, we evaluated that relationship using optical coherence tomography oct a singlecenter, retrospective, observational study was conducted. Experts discuss design, evolution of the xience and promus. Flaring of ostial coronary stent using flash ostial. Mri safety promus element plus everolimuseluting platinum. The promus premier was designed to improve the performance of the promus element, with respect to conformability, trackability, and avoidance of longitudinal stent deformation.
He is a leader of interventional cardiology and has made numerous. Premier has a very similar scaffold design to promus element plus stent with additional connectors within the proximal. Boston scientific announced that it had received fda approval for the promus premier everolimuseluting platinum chromium coronary stent system. Promus element comparable to leading drugeluting stent. Longitudinal stent deformation during coronary intervention. Given the similarities between the promus element and promus premier stent systems and supportive bench and animal study information, the findings from the platinum. Boston scientific promus premier and synergy drugeluting. Angioplasty involves temporarily inserting and inflating a tiny balloon where your artery is clogged to help widen the artery. However, there have been clinical case reports of lsd with the promus premier stent. Pbma, ethylene oxide, esters, amides, anhydrides, reendothelialization, cypher, xience v, promus, endeavor, parylene c, sirolimus, isobutylene, styrene, oxidation, sibs.
Mar 21, 2014 the rebel bare metal stent is similar to the companys drugeluting promus premier stent system, but without everolimus a biological therapy drug that treats advanced kidney cancer, advanced. Promus element plus monorail everolimuseluting coronary. Antonio colombos perspective on the promus premier stent. Boston scientific received ce mark approval for the promus element stent system in 2009 and for the promus element plus stent system in 2011. Food and drug administration fda approval for the promus premier everolimuseluting platinum chromium coronary stent system, the companys nextgeneration durable polymer drugeluting stent des.
Boston scientific awarded fda approval for promus premier. Fda investigating problems where drug eluting stent shrink. The safety and effectiveness of using mechanical atherectomy devices directional atherectomy catheters or rotational atherectomy catheters or laser angioplasty. The promus premier stent system features the only customized stent architecture of its kind providing strength. November 25, 20 natick, massachusetts continuing to advance leading drugeluting stent des technology, boston scientific corporation nyse. Bsx said the fda granted premarket approval for its nextgeneration coronary stent, the promus premier. Pdf the field of percutaneous coronary intervention has witnessed many advances over the last. The promus premier stent system truly is a major step forward in stent technology. According to the fda, both stents are to be used in patients, including those with diabetes, who have narrowing in coronary arteries with length less than or equal to 34 mm with reference vessel diameters greater than or.
The inner lining of the artery grows over the surface of the stent, making the stent a permanent part of your artery. The promus everolimus eluting coronary stent system. Promus premiertmmr everolimuseluting platinum chromium coronary stent system. Fda approves promus element plus and promus premier coronary stent systems. Background recent data suggest that design modifications to the promus element stent which led to the promus premier stent has reduced susceptibility to lsd. Pci case1, and free and smooth passage of secondary catheter across the. Flaring of ostial coronary stent using flash ostial balloon. Ccodes are used for hospital outpatient device reporting for medicare and some private payers. Boston scientific receives fda approval for promus premier everolimuseluting platinum chromium coronary stent system advanced stent technology to launch immediately in the united states. Multicenter trial to assess the promus premier everolimuseluting platinum chromium coronary stent system for the treatment of atherosclerotic lesions. Fda approves promus element plus and promus premier coronary. Once the balloon has been deflated and withdrawn, the stent stays in place permanently, holding the coronary artery open. The promus element plus everolimuseluting chromium platinum coronary stent, a stent used in europe that has been implicated in the longitudinal strength debate in recent months, has been approved. Experts discuss design, evolution of the xience and promus stents.
The stent is placed in a coronary artery to widen and keep the artery open. Conclusions regarding the safety and efficacy of promus premier have been largely extrapolated from clinical experience with promus element. Features the first customized platinum chromium stent architecture, the marketleading everolimus drug and pvdfhfp polymer combination and an enhanced catheter to provide premier outcomes. Everolimus is the active pharmaceutical ingredient in the promus stent. Promus premier stent system boston scientific cardiology. Impact of race and ethnicity on the clinical and angiographic characteristics, social determinants of health, and 1year outcomes after everolimuseluting coronary stent procedures in women. Promus premier drugeluting coronary stent system boston. National library of medicine nlm tools and resources fda udi home fda medical devices home report a device problem medwatch device recalls device safety communications.
No statistically significant differences in tlf components were observed between the two stents. The promus premier boston scientific, which will become commercially available in the near future, is identical to the promus element plus but includes extra connectors on the proximal two. The last generation ptcr platform for the rebel bms boston scientific and promus premier des boston scientific is based on the omegaelement stent. Boston scientific has been awarded fda approval for their newest drug eluting stent, the promus premier everolimuseluting platinum chromium coronary stent system. Pdf advances in coronary stent technology current expectations. Products interventional radiology boston scientific. The stent is made from a platinum chromium alloy ptcr. Due to the extra connectors on the stent, there is a very slight increase in the amount of drug on the promus premier stent. Epic vascular selfexpanding stent system ideal for the iliac. Stent selection for percutaneous coronary intervention. Scientific promus premier, boston scientific synergy, medtronic resolute integrity, and medtronic resolute. The primary endpoint of noninferiority for the promus element stent compared to the promus stent was met with a 12month target lesion failure tlf rate in the per protocol population of 3. Biomatrixand promus premier stent platforms were tested. The ccode used for the promus premier everolimuseluting platinum chromium coronary stent system is c1874 stent, coatedcovered with delivery system.
Everolimuseluting stents in interventional cardiology. Fda investigating problems where drug eluting stent shrink or lengthen november 21, 2011. The company said that the first implantation was scheduled to be performed by martin leon at columbia university. The drugpolymer coating consists of a polymer, pvdfhfp, and the active pharmaceutical ingredient, everolimus. Sep 03, 2014 to evaluate clinical and periprocedural angiographic outcomes for the promus premiertm everolimuseluting platinum chromium coronary stent system in the treatment of subjects with atherosclerotic lesions. Dec 19, 2011 last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. The promus premier stent demonstrated excellent safety and. A patient with this device can be safely scanned in a magnetic resonance system meeting the following conditions.
Nonclinical testing has demonstrated that the promus premier stent is mr conditional for single and overlapped conditions up to 74 mm. There are greater than 300,000 aortoostial stenting procedures performed worldwide each year. Accessgudid promus premier 08714729844587 everolimuseluting platinum chromium coronary stent system. A novel platinum chromium everolimuseluting stent for the. Cardiac death or tv0mi event free event rate p0value1. Percutaneous coronary intervention promus premier promus premier. Synergy everolimuseluting platinum chromium coronary. While reduced strut thickness, increased radiopacity and preserved radial strength are advantages of platinumenriched platforms, the issue of longitudinal stent shortening related to the stent design required the addition of two additional connectors in the proximal stent hoops in. Nov 14, 20 but it occurs in a very low rate and has little impact on clinical outcomes. Fda investigating problems where drug eluting stent shrink or. The stent component of the promus element plus stent system referred to as the promus element stent is a ptcr element stent with a drugpolymer coating.
Last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. The epic stent is a selfexpanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Interventional radiology coding case studies prepared by. The addition of proximal connectors to the premier stent did not appear to significantly impact stent profile or deliverability, as procedural success rates were in excess of 99%. Nov 21, 2011 federal regulators are investigating reports involving problems with drugeluting stents, where the small wire devices may become deformed once implanted in patient arteries. Woon rha, md, phd, facc, faha, fesc, fscai, fapsic cardiovascular center. In this editorial, we provide an overview of the development of coronary stents since. Fda approves promus premier everolimuseluting platinum chromium coronary stent system.
The promus element consists of the newly developed element stent platform that is coated with a polymer total polymer thickness of 7. But it occurs in a very low rate and has little impact on clinical outcomes. Neointimal coverage after second generation drugeluting. Figure 1 the promus premier stent boston scientific, natick, ma, usa. The promus premier stent system offers physicians improved des performance in treating patients with coronary artery disease, and features unique customized platinum chromium alloy stent. May 30, 2017 metal composition boston scientific metal composition. Primary endpoint from study of drug eluting coronary stent in underserved patient populations presented at tct 2016 read this article along with other careers information, tips and advice on biospace. Promus premier versus xience v and taxus liberte in. Abbott xience prime des and boston scientific promus element des on file at medtronic, inc. The relationship between preexisting atherosclerotic lesion characteristics and neointimal thickness after secondgeneration drugeluting stent des placement is still unknown.
These primarily biostable polymers bind the drug to the stent and modulate the elution of the drug into the arterial tissue. Drugeluting stents des compared to bare metal stents bms. Promus premier stent system platinum workhorse trial. Fda reprimands 23andme, grants breakthrough status to factor.
The recent leaders free trial investigating the poly. The stent also slowly releases a medicine, everolimus, which helps prevent the stented artery from becoming blocked again. Boston sci promus premier drug eluting stent now available in. Drugeluting stents reduce the need for target vessel revascularization compared with bare metal stents, and thereby result in superior costeffectiveness. Promus premier everolimuseluting platinum chromium coronary stent system. The safety and effectiveness of the promus premier stent in patients with prior brachytherapy of the target lesion have not been established. It introduces additional connectors within the proximal end of the stent to increase axial strength and resistance to stent deformation. Federal law usa restricts this device to sale by or on the order of a physician.
The promus element and promus premier stents utilize the same platinum chromium alloy and the same everolimus and pvdfhfp coating, resulting in a similar kinetic release profile. The vici venous stent system is a nitinol selfexpanding stent specifically designed to meet the challenges of venous anatomy. The anatomic nature of percutaneous stenting of aortoostial lesions remains an angiographic challenge for interventional cardiologists. Metal composition boston scientific metal composition. The characteristics of the promus element plus stent system are described in table 2.
Jun 19, 20 promus element ptcr everolimuseluting stent. Promus premier indications, safety, and warnings boston. Boston scientific wins fda approval for promus premier stent. Analysis of the data was presented at europcr 2012 in paris. It will be solved by the new design of the promus premier stent, he said. Singlearm treatment group receiving interventional promus primier study stent.
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