Coronary angioplasty anjeeoplastee, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries. Boston scientific promus premier and synergy drugeluting. The promus premier stent system is currently offered in a matrix of 47 sizes, ranging in diameter from 2. Antonio colombos perspective on the promus premier stent. The relationship between preexisting atherosclerotic lesion characteristics and neointimal thickness after secondgeneration drugeluting stent des placement is still unknown.
Fda reprimands 23andme, grants breakthrough status to. 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. Boston sci promus premier drug eluting stent now available. Boston scientific announced that it had received fda approval for the promus premier everolimuseluting platinum chromium coronary stent system.
Singlearm treatment group receiving interventional promus primier study stent. Mri safety promus element plus everolimuseluting platinum. Promus element plus monorail everolimuseluting coronary. Figure 1 the promus premier stent boston scientific, natick, ma, usa. Last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. November 25, 20 natick, massachusetts continuing to advance leading drugeluting stent des technology, boston scientific corporation nyse. 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. 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. The promus premier stent system features the only customized stent architecture of its kind providing strength.
Promus element plus everolimuseluting platinum chromium coronary stent system synergy everolimuseluting platinum chromium coronary stent system promus premier everolimuseluting platinum chromium coronary stent system. Nov 14, 20 but it occurs in a very low rate and has little impact on clinical outcomes. 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. 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. Nonclinical testing has demonstrated that the promus premier stent is mr conditional for single and overlapped conditions up to 74 mm. Food and drug administration fda approval for the promus premier everolimuseluting platinum chromium coronary stent system, the companys nextgeneration durable polymer drugeluting stent des. Fda approves promus element plus and promus premier coronary. The last generation ptcr platform for the rebel bms boston scientific and promus premier des boston scientific is based on the omegaelement stent. Given the similarities between the promus element and promus premier stent systems and supportive bench and animal study information, the findings from the platinum. The stent is placed in a coronary artery to widen and keep the artery open. A patient with this device can be safely scanned in a magnetic resonance system meeting the following conditions.
It introduces additional connectors within the proximal end of the stent to increase axial strength and resistance to stent deformation. Jun 19, 20 promus element ptcr everolimuseluting stent. The promus everolimus eluting coronary stent system. 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. The characteristics of the promus element plus stent system are described in table 2. Background recent data suggest that design modifications to the promus element stent which led to the promus premier stent has reduced susceptibility to lsd. But it occurs in a very low rate and has little impact on clinical outcomes. Features the first customized platinum chromium stent architecture, the marketleading everolimus drug and pvdfhfp polymer combination and an enhanced catheter to provide premier outcomes. Flaring of ostial coronary stent using flash ostial. Promus premier stent system platinum workhorse trial. Stent selection for percutaneous coronary intervention. 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. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. 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.
Fda approves promus element plus and promus premier. It will be solved by the new design of the promus premier stent, he said. Fda investigating problems where drug eluting stent shrink. Boston scientific promus premier and synergy drugeluting stent systems provide exceptional safety and efficacy data. The promus element consists of the newly developed element stent platform that is coated with a polymer total polymer thickness of 7. 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. Pdf advances in coronary stent technology current expectations. Promus premier indications, safety, and warnings boston.
Promus element plus everolimuseluting platinum chromium coronary stent system below is an excerpt of section 6. Epic vascular selfexpanding stent system ideal for the iliac. Pbma, ethylene oxide, esters, amides, anhydrides, reendothelialization, cypher, xience v, promus, endeavor, parylene c, sirolimus, isobutylene, styrene, oxidation, sibs. Fda investigating problems where drug eluting stent shrink or lengthen november 21, 2011. Analysis of the data was presented at europcr 2012 in paris. 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. Drugeluting stents des compared to bare metal stents bms. The company said that the first implantation was scheduled to be performed by martin leon at columbia university. The promus element plus everolimuseluting chromium platinum coronary stent, a stent used in europe that has been implicated in the longitudinal strength debate. Everolimuseluting stents in interventional cardiology. Premier has a very similar scaffold design to promus element plus stent with additional connectors within the proximal. The stent also slowly releases a medicine, everolimus, which helps prevent the stented artery from becoming blocked again. The inner lining of the artery grows over the surface of the stent, making the stent a permanent part of your artery. Promus element plus monorail everolimuseluting coronary stent system is a medical device used to treat patients who have coronary artery disease.
Longitudinal stent deformation during coronary intervention. May 30, 2017 metal composition boston scientific metal composition. 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. 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 anatomic nature of percutaneous stenting of aortoostial lesions remains an angiographic challenge for interventional cardiologists. In this editorial, we provide an overview of the development of coronary stents since. Cardiac death or tv0mi event free event rate p0value1. Accessgudid promus premier 08714729844587 everolimuseluting platinum chromium coronary stent system. Clinical utility of platinum chromium baremetal stents in. Boston sci promus premier drug eluting stent now available in. Interventional radiology coding case studies prepared by. Ccodes are used for hospital outpatient device reporting for medicare and some private payers.
Abbott xience prime des and boston scientific promus element des on file at medtronic, inc. However, there have been clinical case reports of lsd with the promus premier stent. Fda investigating problems where drug eluting stent shrink or. Antonio colombo is director of interventional cardiology at san raffaele hospital and colombus hospital in milan, italy. The recent leaders free trial investigating the poly. Synergy everolimuseluting platinum chromium coronary. Once the balloon has been deflated and withdrawn, the stent stays in place permanently, holding the coronary artery open. The vici venous stent system is a nitinol selfexpanding stent specifically designed to meet the challenges of venous anatomy. Promus element comparable to leading drugeluting stent. The ccode used for the promus premier everolimuseluting platinum chromium coronary stent system is c1874 stent, coatedcovered with delivery system.
The safety and effectiveness of the promus premier stent in patients with prior brachytherapy of the target lesion have not been established. 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. Multicenter trial to assess the promus premier everolimuseluting platinum chromium coronary stent system for the treatment of atherosclerotic lesions. Boston scientific awarded fda approval for promus premier. Longitudinal deformation bench testing using a coronary. Experts discuss design, evolution of the xience and promus. The epic stent is a selfexpanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. The promus premier stent system truly is a major step forward in stent technology. Boston scientific received ce mark approval for the promus element stent system in 2009 and for the promus element plus stent system in 2011. These primarily biostable polymers bind the drug to the stent and modulate the elution of the drug into the arterial tissue. Due to the extra connectors on the stent, there is a very slight increase in the amount of drug on the promus premier stent. 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. Everolimus is the active pharmaceutical ingredient in the promus stent. Conclusions regarding the safety and efficacy of promus premier have been largely extrapolated from clinical experience with promus element.
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. Boston scientific receives fda approval for promus premier everolimuseluting platinum chromium coronary stent system advanced stent technology to launch immediately in the united states. Fda approves promus premier everolimuseluting platinum chromium coronary stent system. He is a leader of interventional cardiology and has made numerous. Bsx said the fda granted premarket approval for its nextgeneration coronary stent, the promus premier. Scientific promus premier, boston scientific synergy, medtronic resolute integrity, and medtronic resolute. Promus premier stent system boston scientific cardiology. Promus premier everolimuseluting platinum chromium coronary stent system. 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. 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. Neointimal coverage after second generation drugeluting.
Flaring of ostial coronary stent using flash ostial balloon. Boston scientific wins fda approval for promus premier stent. Angioplasty involves temporarily inserting and inflating a tiny balloon where your artery is clogged to help widen the artery. Boston scientific has been awarded fda approval for their newest drug eluting stent, the promus premier everolimuseluting platinum chromium coronary stent system.
Antonio colombos perspective on the promus premier stent boston scientific cardiology. Woon rha, md, phd, facc, faha, fesc, fscai, fapsic cardiovascular center. No statistically significant differences in tlf components were observed between the two stents. A novel platinum chromium everolimuseluting stent for the. Thus, we evaluated that relationship using optical coherence tomography oct a singlecenter, retrospective, observational study was conducted. Promus premier drugeluting coronary stent system boston.
Biomatrixand promus premier stent platforms were tested. Percutaneous coronary intervention promus premier promus premier. The promus premier was designed to improve the performance of the promus element, with respect to conformability, trackability, and avoidance of longitudinal stent deformation. The drugpolymer coating consists of a polymer, pvdfhfp, and the active pharmaceutical ingredient, everolimus. Pci case1, and free and smooth passage of secondary catheter across the. The promus premier stent demonstrated excellent safety and. Promus premiertmmr everolimuseluting platinum chromium coronary stent system. Drugeluting stents reduce the need for target vessel revascularization compared with bare metal stents, and thereby result in superior costeffectiveness. Fda approves promus element plus and promus premier coronary stent systems.
Pdf the field of percutaneous coronary intervention has witnessed many advances over the last. 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. There is a proximal 70% stenosis in the native lad proximal at the stent. 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%. Federal law usa restricts this device to sale by or on the order of a physician. The stent is made from a platinum chromium alloy ptcr. The safety and effectiveness of using mechanical atherectomy devices directional atherectomy catheters or rotational atherectomy catheters or laser angioplasty. Experts discuss design, evolution of the xience and promus stents. 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. Promus premier versus xience v and taxus liberte in.
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