Drugeluting biostable and erodible stents sciencedirect. This advanced des system recently received japan ministry of health, labor and welfare mhlw approval. Though, the reported cases are with all type of stents, it is common with promus element stent. The promus element stent, part of the promus element stent system and the promus element plus stent system, employs a proprietary ptcr alloy designed specifically for coronary stenting, which the company claims enables enhanced visibility, less. The warranty shall be invalidated by damage caused by operating errors. A prospective, randomized evaluation of a novel everolimuseluting coronary stent. 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. Licensed from abbott laboratories which sells under the xience name, promus sales in 2011 represent a big decline from 2010. I had a drug eluting stent promus premier boston scientific 2016 and i keep having pain and my doctor checked it out when i was admitted to the hospital was told that i had a broken stent and wasnt going to mess with it cause it was in the smallest artery. Natick, ma prnewswire continuing to advance leading drugeluting stent des technology, boston scientific corporation nyse. 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. 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.
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. Occasionally, stent thrombosis can also be a symptom of an underlying disease process as in the presented case. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. Full text clinical utility of platinum chromium baremetal stents in. Some stents are coated with medicine, some are not. Mri safety promus element plus everolimuseluting platinum. Promus premiermonoraileverolimuseluting platinum chromium coronary stent system 8mm x 2.
Boston scientific, 395281635, boston scientific promus. According to a company release, the promus premier boston scientific is designed to provide physicians improved drugeluting stent performance in treating patients with coronary artery disease. Food and drug administration fda approval for the promus premier everolimuseluting platinum chromium coronary stent system, the companys nextgeneration durable polymer drugeluting stent des. A recent report confirmed an increased longitudinal strength of the promus premier stent in bench testing. Youre describing tissue buildup on the ends of the stent, also called edge restenosis. Food and drug administration fda to treat coronary artery disease. Boston sci promus premier drug eluting stent now available in. Coronary stents resolute onyx drugeluting stent medtronic.
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. The stent also slowly releases a medicine, everolimus, which helps prevent the stented artery from becoming blocked again. Bsx has launched the promus premier everolimuseluting platinum chromium coronary stent system in japan. Bsx stents promus elementtm, promus elementtm plus. November 25, 20 natick, massachusetts continuing to advance leading drugeluting stent des technology, boston scientific corporation nyse.
The drug is released from the stent over the period of time during which reblockage is most likely to occur. Theresa the promus is a drugeluting or coated stent it is the same stent as the xience v just manufactured by two different companies. Publications home of jama and the specialty journals of the. Download prominent promus series operating instructions manual. Trial data shows superior efficacy of promus element. The 8month clinical results from 2 centers in korea showed that instent late loss was significantly lower in the cilotax stent than in the pes 0. Listing a study does not mean it has been evaluated by the u.
Xience alpine is part of the xience family of drugeluting stents des and is designed for complex percutaneous coronary intervention pci. The blood carries oxygen and nutrients that your body needs to work correctly. The stent was designed to be very flexible, allowing it to fit. The promus premier stent system is the companys latest durable polymer drugeluting stent des and is approved by the u. Stent thrombosis is the most feared complication after coronary stent implantation, although its incidence has been reduced by potent antiplatelet therapy, improvements in stent design and procedural technique. Jun 19, 20 promus element ptcr everolimuseluting stent.
If you have a stent the catheter will have a small balloon with a stent on the end. Ccodes are used for hospital outpatient device reporting for medicare and. A patient with this device can be safely scanned in a magnetic resonance system meeting the following conditions. Dec 19, 2011 last month, the fda approved boston scientifics promus element heart stent, a tiny tubular device designed to open diseased arteries. After using this product for nearly a year, i am confident that. 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. Eculizumab treatment for paroxysmal nocturnal haemoglobinuria. The characteristics of the promus element plus stent system are described in table 2. It is either caused by impact of guide catheters tip at proximal or. Promus premier flexible stent design boston scientific.
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. 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. Promus element plus us postapproval study full text. Boston scientific launches promus premier stent in europe. Promus premier everolimuseluting platinum chromium stent.
The promus premier stent system features the only customized stent architecture of its kind providing strength. Boston scientific awarded fda approval for promus premier. Efficacy of xiencepromus versus cypher in reducing late loss. You have recently had a promus premier drugcoated stent implanted in the coronary arteries of your heart. Promus premier drugeluting coronary stent system boston. Promus elite permanent polymer drugeluting stent boston. Clinical and angiographic outcomes of bioabsorbable vs. Biomatrixand promus premier stent platforms were tested. The drugpolymer coating consists of a polymer, pvdfhfp, and the active pharmaceutical ingredient, everolimus.
A total of consecutive allcomer patients including acute coronary syndrome, multivessel disease, calcified lesions treated with an eepcs. Food and drug administration fda approval for the promus premier everolimuseluting platinum chromium coronary stent system, the companys next. Bsx reports positive results from two trials evaluating new, innovative drugeluting stent des technologies, which. Fda investigating problems where drug eluting stent shrink or. Bsx said the fda granted premarket approval for its nextgeneration coronary stent, the promus premier. The promus elite stent system combines a unique customized stent architecture, the marketleading everolimus and pvdfhfp polymer combination, and an enhanced delivery system for outstanding acute performance backed by proven longterm outcomes. 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.
The stent is made from a platinum chromium alloy ptcr. Promus element plus everolimuseluting platinum chromium coronary stent system description. Read download file report abuse premier colors by lyon lyon workspace 4a steel blue. Promus registry experience at the washington hospital center, drugeluting stent des prewards the safety and scientific validity of this study is. Promus premier everolimuseluting platinum chromium coronary stent system click on image to view large version dr. Our unique platinum chromium ptcr stent alloy can help reduce device usage, procedure times and radiation exposure. The stent is also sold by boston scientific under an agreement with abbott as the promus stent. Promus premier stent n15, xience xpedition stent n3, xience v stent n10 and resolute integrity stent n3. Boston scientific announces results from promus premier. Promus premiertmmr everolimuseluting platinum chromium coronary stent system. Antonio colombo gives an overview of the promus premier stent. Xience, which slowly releases everolimus to inhibit restenosis, is widely recognized for its unparalleled safety.
Promus everolimuseluting coronary stent system boston. Boston scientific launches promus premier everolimus. Due to the extra connectors on the stent, there is a very slight increase in the amount of drug on the promus premier stent. March 29, 2012 twoyear followup data from the pivotal platinum workhorse trial comparing the safety and effectiveness of the promus element and xience v everolimuseluting coronary stents demonstrated superior efficacy of the promus. The promus element consists of the newly developed element stent platform that is coated with a polymer total polymer thickness of 7. Changes to automate serial number label printing and file deletion via usb file manager. Advanced stent technology to launch immediately in the united states.
Boston scientific promus premier and synergy drugeluting. Your doctor will choose the stent that is right for you. Boston scientific receives fda approval for promus premier everolimuseluting platinum chromium coronary stent system advanced stent technology to launch immediately in the united states. Promus premier platinum chromium stent system todays. Coronary angiogram, angioplasty and stent placement. The customized platinum chromium stent architecture maintains.
Promus element plus everolimuseluting platinum chromium coronary stent system below is an excerpt of section 6. Boston scientific wins fda approval for promus premier stent. Experts discuss design, evolution of the xience and promus stents. This study evaluate the clinical outcomes of the promus premier stent in women and minorities. Nonclinical testing has demonstrated that the promus premier stent is mr conditional for single and overlapped conditions up to 74 mm. The promus premier stent system truly is a major step forward in stent technology. Promus element represents boston scientifics goal of making and selling its own drugeluting stents, rather than relying on licensing like it did with the predecessor promus stent. Promus element plus everolimuseluting platinum chromium. No statistically significant differences in tlf components were observed between the two stents. For the heart to be able to function properly, it also needs a constant supply of. Antonio colombo gives an overview of the promus premier stents flexibility, conformability, visibility, and everolimus drugpvdfhfp polymer combination.
Promus element plus monorail everolimuseluting coronary stent system is a medical device used to treat patients who have coronary artery disease. 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. Background recent data suggest that design modifications to the promus element stent which led to the promus premier stent has reduced susceptibility to lsd. A novel platinum chromium everolimuseluting stent for the. Promus element comparable to leading drugeluting stent. Platinum workhorse trial studied the promus element stent promus ptcr ees and xience v stent xience cocr ees.
Download catalogs by product family in pdf format, or view the entire abbott. 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. Promus premier everolimuseluting platinum chromium. The promus premier everolimuseluting platinum chromium stent.
The promus element represents the companys thirdgeneration drugeluting stent des technology, which incorporates a novel platinum chromium ptcr alloy, innovative stent design and advanced catheter delivery system. The ccode used for the promus premier everolimuseluting platinum chromium coronary stent system is c1874 stent, coatedcovered with delivery system. Boston scientific has been awarded fda approval for their newest drug eluting stent, the promus premier everolimuseluting platinum chromium coronary stent system. Coronary promus everolimuseluting coronary stent system. Clinical studies boston scientific boston scientific. After adjustment for differences in the baseline risk factors, a stent length of. Since the inclusion of stents with different characteristics in the pp and bpdes is based on the assumption of a common class effect, we restricted the analysis to promus type des promus element, promus element plus and promus premier and synergy which differ for the type of polymer permanent vs. Testing performed on smallest diameters available for abbott xience alpine, biotronik orsiro, boston scientific promus premier, boston scientific synergy, medtronic resolute integrity, and medtronic resolute onyx coronary stents. Fda approves promus element plus and promus premier coronary. Images of the promus premier stent system are available for download here. After using this product for nearly a year, i am confident that boston scientific has advanced thinstrut technology, said john ormiston, m. Boston scientific initiates study of promus premier. Fda issues warning on boston scientific heart stents.
Promus element plus monorail everolimuseluting coronary. The promus premier drugeluting stent from boston scientific features customized. Abbott xience prime des and boston scientific promus element des on file at medtronic, inc. Ma monthly approvals from 1112017 to 12017 original. The promus premier stent is a baremetal stent with a special drug coating added to help reduce the chance of the artery becoming blocked again. Operating instructions promus series o metering pumps.
The promus element plus everolimuseluting chromium platinum coronary stent, a stent used in europe that has been implicated in the longitudinal strength debate. The advanced lowprofile delivery system facilitates precise delivery of the stent across challenging lesions. Bsx said it plans to immediately launch its promus premier drugeluting stent across the pond, now that the european union has given the device ce mark approval. Coronary stent manufacturer price excl local taxes. Jun 17, 2008 efficacy of xiencepromus versus cypher in reducing late loss after stenting excellent the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Boston scientific is dedicated to transforming lives through innovative medical solutions. Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart. Promus element the top drugeluting stents fiercebiotech. Promus registry experience at the washington hospital. Longitudinal deformation bench testing using a coronary. The stent is placed in a coronary artery to widen and keep the artery open. Nov 14, 20 it will be solved by the new design of the promus premier stent, he said.
Promus premier indications, safety, and warnings boston. Promus premiermonoraileverolimuseluting platinum chromium coronary stent systemnonexpired38mm x 3. Longitudinal stent deformation during coronary intervention. May 30, 2017 read download file report abuse premier colors by lyon lyon workspace 4a steel blue.