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. After adjustment for differences in the baseline risk factors, a stent length of. Clinical studies boston scientific boston scientific. Boston sci promus premier drug eluting stent now available in. Boston scientific receives fda approval for promus premier. Experts discuss design, evolution of the xience and promus stents. It will be solved by the new design of the promus premier stent, he said.
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. Coronary stents resolute onyx drugeluting stent medtronic. Stent loss during percutaneous coronary intervention pci is an infrequentl coronary event, and yet it is associated with an increased risk of complications. Occurrence and predictors of acute stent recoila comparison. The objective was to obtain mechanical parameters for direct comparison of bms and des. Promus premier drugeluting coronary stent system boston. Stents must be securely crimped onto the delivery balloon and, in this form, must have a low profile and be sufficiently flexible to facilitate deliverability to the lesion site without distortion or displacement. 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 element plus monorail everolimuseluting coronary stent system is a medical device used to treat patients who have coronary artery disease. Due to the extra connectors on the stent, there is a very slight increase in the amount of drug on the promus premier stent. Promus premier versus xience v and taxus liberte in.
Incidence and clinical impact of stent fracture after promus. Synergy everolimuseluting platinum chromium coronary. Federal regulators are investigating reports involving problems with drugeluting stents, where the small wire devices may become deformed once implanted in. Coronary promus everolimuseluting coronary stent system. November 25, 20 natick, massachusetts continuing to advance leading drugeluting stent des technology, boston scientific corporation nyse. Request pdf occurrence and predictors of acute stent recoila comparison between the xience prime cobalt chromium stent and the promus premier platinum chromium stent objectives. The stent is made from a platinum chromium alloy ptcr.
Stent longitudinal strength assessed using point compression. Promus element plus everolimuseluting platinum chromium coronary stent system below is an excerpt of section 6. Boston scientific is dedicated to transforming lives. Boston scientific promus premier and synergy drugeluting. The promus premier stent system truly is a major step forward in stent technology. Dec 01, 2014 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. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. Stents versus bypass surgery for left main stem stenosis. 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. All samples are drugeluting stent systems representing current state of the art. Successful retrieval of a lost coronary stent from a renal artery has not been reported. The results showed that there were no significant outcome differences between white men and women or minorities for the composite primary endpoint of death, myocardial infarction or target vessel revascularization at 12 months.
Angiographic and oct images of the om artery with stentinstent thrombosis a angiographic haziness white arrow, online video 1 seen in the ostial segment of the om artery that was stented promus premier 3. Angioplasty involves temporarily inserting and inflating a tiny balloon where your artery is clogged to help widen the artery. B angiogram online video 3 after deployment of a new stent promus premier 3. A patient with this device can be safely scanned in a magnetic resonance system meeting the following conditions. Fda approves promus element plus and promus premier. May 30, 2017 premier metalenclosed and metal clad switchgear for indoor or outdoor applications ranging from 5kv to 38kv. Fda approves promus element plus and promus premier coronary. Promus premier stent n15, xience xpedition stent n3, xience v stent n10 and resolute integrity stent n3.
Compared to the earliergeneration promus element stent with 2 stent hoop connectors, the promus premier has 2 additional connectors at. Fda investigating problems where drug eluting stent shrink. The ideal stent must fulfil a broad range of technical requirements. Mri safety promus element plus everolimuseluting platinum. Antonio colombos perspective on the promus premier stent. The stent also slowly releases a medicine, everolimus, which helps prevent the stented artery from becoming blocked again. 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. We investigated five commercially available stent systems a nominal diameter of 3.
Coronary angioplasty anjeeoplastee, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries. The promus premier everolimuseluting platinum chromium stent. Drugeluting coronary artery stent, nonbioabsorbablepolymercoated a sterile nonbioabsorbable metal tubular mesh structure covered with a nonbioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery or saphenous vein graft to maintain its patency typically in a patient with. Incidence and clinical impact of stent fracture after. Download pdf the promus premier everolimuseluting platinum chromium stent with durable polymer evaluated in a real world allcomer population in rotterdam cardiology hospital the psearch registry. Analysis of the data was presented at europcr 2012 in paris. Last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. Promus element plus monorail everolimuseluting coronary. Promus element plus everolimuseluting platinum chromium coronary stent system synergy everolimuseluting platinum chromium coronary stent system promus premier everolimuseluting platinum chromium coronary stent system.
A 71yearold man was admitted for acute coronary syndrome. The resolute onyx drugeluting stent is an advanced workhorse des ready for your challenging coronary cases. The characteristics of the promus element plus stent system are described in table 2. The promus premier was designed to improve the performance of the promus element, with respect to conformability, trackability, and avoidance of longitudinal stent deformation. 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. The ccode used for the promus premier everolimuseluting platinum chromium coronary stent system is c1874 stent, coatedcovered with delivery system.
Boston scientific received ce mark approval for the promus element stent system in 2009 and for the promus element plus stent system in 2011. Ccodes are used for hospital outpatient device reporting for medicare and some private payers. Promus premier indications, safety, and warnings boston. Longitudinal deformation bench testing using a coronary. No previous studies have evaluated the performance of the synergy stent in a large real. Platinum workhorse trial studied the promus element stent promus ptcr ees and xience v stent xience cocr ees. Experts discuss design, evolution of the xience and promus. The promus premier stent system features the only customized stent architecture of its kind providing strength. A total of 123 lesions 61 xience prime vs 62 promus premier in 100 patients were analyzed. Xience alpine everolimus eluting coronary stent system. Background recent data suggest that design modifications to the promus element stent which led to the promus premier stent has reduced susceptibility to lsd. Retrieval of dislodged coronary stent from left renal. The stent is placed in a coronary artery to widen and keep the artery open.
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. Xience, which slowly releases everolimus to inhibit restenosis, is widely recognized for its unparalleled safety. Xience alpine is part of the xience family of drugeluting stents des and is designed for complex percutaneous coronary intervention pci. Drugeluting stents des compared to bare metal stents bms have shown superior clinical performance, but are considered less suitable in complex cases. Most dislodged coronary stents were lost and retrieved within the coronary artery. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned study treatment six 1% in the zotarolimuseluting stent group vs five 1% in the. 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. Although our firstgeneration compression test provided insights into stent design and performance, and led to recommendations on stent design improvements, a shortcoming of. Nov 14, 20 it will be solved by the new design of the promus premier stent, he said. The promus premier everolimuseluting platinum chromium.
The rebel bare metal stent is similar to the companys drugeluting promus premier stent system, but without everolimus a biological therapy. Jonathan watt and colleagues ask for detailed information about stent thrombosis in the noble trial. Dec 19, 2011 last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. Promus premier promus elite permanent polymer drugeluting stent. Promus everolimuseluting coronary stent system boston. Alper oner expansion characteristics of coronary stents in. Boston sci promus premier drug eluting stent now available. Boston scientific awarded fda approval for promus premier. A novel platinum chromium everolimuseluting stent for the. Most studies do not distinguish between des and bms with respect to their mechanical performance. The drugpolymer coating consists of a polymer, pvdfhfp, and the active pharmaceutical ingredient, everolimus. Embolic protection system and closed cell selfexpanding stent. 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 has been awarded fda approval for their newest drug eluting stent, the promus premier everolimuseluting platinum chromium coronary stent system.
Significant acute stent recoil was defined as recoil. Ccodes are used for hospital outpatient device reporting for medicare and. The promus element plus everolimuseluting chromium platinum coronary stent, a stent used in europe that has been implicated in the longitudinal strength debate. 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. Our unique platinum chromium ptcr stent alloy can help reduce device usage, procedure times and radiation exposure. 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. All samples are drugeluting stent systems representing current state of. Jun 19, 20 promus element ptcr everolimuseluting stent. 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.
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