Medtronic nets new indications for resolute integrity. A single strand of cobalt alloy is formed into a sinusoid, wrapped in a helical pattern, and laser fused. Medtronic starts trials of endeavor resolute drugeluting coronary stent clinical research teams led by interventional cardiologists dr. Revolutionary stent engineering provides superior deliverability and conformability with enhanced procedural confidence vs. Medtronic launches resolute onyxtm drugeluting stent in. The device is based on the companys resolute integrity device and is.
Resolute zotarolimus eluting stent for treatment of long. Alan yeung, a principal investigator of resolute us, makes all the difference. Jan 20, 2017 longterm followup from the twente triala randomized comparison of the endeavour resolute zotarolimuseluting stent and the xience v everolimuseluting stentshows the two stents have similar rates of target vessel failure at 5 years, as well as low rates of definite andor probable stent thrombosis. May 15, 2012 as europcr 2012 gets underway, medtronic inc. Xience is the worlds leading drugeluting stent with an unrivaled safety record. The first stent to have an indication for the treatment of coronary artery disease in diabetic patients, the stent has enjoyed rapid adoption in the clinical arena.
Fda approves medtronics resolute drugeluting stent for. Resolute onyx des indications, safety, and warnings. Cst is a unique medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The resolute des is approved for use in a wide variety of patients, including. The medtronic resolute onyx zotarolimuseluting coronary stent system resolute onyx system is a devicedrug combination product comprised of the following device components.
Abbott xience prime des and boston scientific promus element des on file at medtronic, inc. The resolute onyx des provides physicians with an additional 4. This study sought to assess the clinical safety and effectiveness of the resolute zotarolimuseluting stent rzes in patients with in stent restenosis isr from 2 large trials. Xience sierra continues to provide unparalleled safety 1 along with enhanced deliverability for even the most complex percutaneous coronary interventions pci. Skeldings analysis shows that the performance of the resolute des persists out to three years in the diabetes subgroup, despite the higher risk nature of the diabetes patient population. The resolute onyx drugeluting stent is an advanced workhorse des ready for your challenging coronary cases. The resolute integrity stent is a zotarolimuseluting system with a new biolinx. Drug eluding stent with first and only stent with diabetic indication.
The fda has approved the new resolute integrity zotarolimuseluting coronary stent, the first des approved by the regulatory body for use in patients with diabetes, who account for onethird of. Fda clears medtronics resolute onyx drugeluting stent. Feb 17, 2012 the fda has approved the medtronic resolute zotarolimuseluting stent for the treatment of coronary artery disease. Optimal duration of clopidogrel in secondgeneration drugeluting stents optimac the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Virtual bench testing of new generation coronary stents. Endeavorresolute the top drugeluting stents fiercebiotech. Woon rha, md, phd, facc, faha, fesc, fscai, fapsic cardiovascular center, korea university guro hospital, seoul, korea. Optimal duration of clopidogrel in secondgeneration drug. Medtronic resolute integrity drugeluting stent obtains fda. Feb 23, 2012 drug eluding stent with first and only stent with diabetic indication. The medtronic resolute clinical trial full text view. Excellent efficacy and safety proven in more than 5000 patients first and only des fdaapproved for patients with diabetes. Resolute and xience stents show comparable outcomes.
Medtronic starts trials of endeavor resolute drugeluting. A stent is an expandable metal tube that is used to treat weak arteries. The 38 mm length rzes allows for the treatment of longer lesions with a single stent with outcomes similar to those observed in shorter lesions. Longterm followup from the twente triala randomized comparison of the endeavour resolute zotarolimuseluting stent and the xience v everolimuseluting stentshows the two stents have similar rates of target vessel failure at 5 years, as well as low rates of definite andor probable stent thrombosis. Japan may be key to further propelling resolute stent sales endeavorresolute the top drugeluting stents book traversal links for endeavorresolute. Medtronic won fda regulatory approval and is releasing in the u. Jul 08, 20 discover the advantages of the new resolute onyx 4. These stents help in opening up arteries that are narrowed down by the accumulation of plaques. The resolute integrity zotarolimuseluting stent in coronary.
Medtronics resolute integrity drug eluting stent has been cleared by the fda for treatment of coronary artery disease. May 01, 2017 medtronic launches resolute onyxtm drugeluting stent in united states following fda approval becoming first des available in 4. Discover the advantages of the new resolute onyx 4. Medtronic launches resolute onyx drugeluting stent in. Conclusions in this first report of a drugeluting stent with a dedicated size to treat lesions with rvd resolute onyx 2. Resolute integrity is the only drugeluting stent to hold this indication from the fda. Coronary stents resolute onyx drugeluting stent medtronic. Stent diameter mm postdilatation limit mm stent length mm added sizes postdilatation limit. Serruys and fellow investigators concluded that there was no difference between the safety and efficacy outcomes between medtronics resolute zotarolimuseluting. Resolute integrity drug eluting stent safety and efficacy for the treatment of coronary artery disease. Drug load comparison total drug load is identical for both stents total drug load is. Caution federal usa law restricts this device to sale by or on the order of a physician. One of the early limitations to stent use was the development of subacute stent closure which occurred when blood clots formed within the stent to shut off blood flow to the heart muscle.
The resolute integrity stent system provides superior deliverability and powerful performance for complex daily practice, said sean salmon, vice president and general manager of medtronics coronary and peripheral division. Resolute matched cohort compared against prespecified performance goal based on des metaanalysis. In summary, the data presented by bahuleyan et al and the resolute clinical trial program data suggest that rzes is an excellent choice for the treatment of long coronary lesions. Stent stent length mm diameter mm 8 12 14 18 22 26 30. Medtronics resolute stent equivalent to xience v at two years.
April 3, 2011 presenting the two year data from the resolute allcomers trial at todays latebreaking sessions at the american college of cardiologys 60th annual scientific session in new orleans, dr. Xience v and magnetic resonance imaging examination. Bestinclass stent technology based on bench test data vs. The need to develop a local antirestenotic mechanism to prevent in stent thrombosis has driven the. The following case study illustrates the effective use of this stent in a diabetic patient. Resolute integrity zotarolimuseluting coronary stent. The resolute onyx des is the first and only des to feature core wire technology, an evolution of continuous sinusoid technology cst. Platinum workhorse trial studied the promus element stent promus ptcr ees and xience v stent xience cocr ees. It offers physicians a compelling new treatment option for patients with coronary artery disease. Conclusions in this first report of a drugeluting stent with a dedicated size to treat lesions with rvd onyxtm drugeluting stent sizes and expands indications.
Medtronic launches resolute onyx drugeluting stent in united states following fda approval becoming first des available in 4. Medtronic launches resolute onyxtm drugeluting stent in united states following fda approval becoming first des available in 4. Resolute onyx zotarolimuseluting coronary stent system. Serruys and fellow investigators concluded that there was no difference between the safety and efficacy outcomes between medtronics resolute. Resolute onyx drug eluting coronary stent from medtronic. Nov 12, 2012 japan may be key to further propelling resolute stent sales endeavorresolute the top drugeluting stents book traversal links for endeavorresolute the top drugeluting stents. Promus premier drugeluting coronary stent system boston. Resolute integrity zotarolimuseluting coronary stent system rapid exchange delivery system instructions for use caution federal usa law restricts this device for sale by or on the order of a physician.
Medtronic resolute integrity drugeluting stent obtains fda approval for treating coronary artery disease distinguished by superior deliverability and diabetes indication, new heart device becomes. While boston scientifics new stent is the same as the promus, but with a different stent alloy, medtronics new stent, the resolute, is the same as its endeavor, but with a different polymer and a much longer rate of drug elution and that, says dr. Resolute matched cohort compared against prespecified performance goal based on. The medtronic resolute integrity zotarolimuseluting coronary stent system resolute integrity system is a devicedrug combination product comprised of the following device components. Medtronic resolute integrity drugeluting stent obtains. Per the resolute integrity des instructions for use. The ccode used for the promus premier everolimuseluting platinum chromium coronary stent system is c1874 stent, coatedcovered with delivery system. Xience sierra continues to provide unparalleled safety 1 along with enhanced deliverability for even the most complex percutaneous coronary interventions.
Resolute zotarolimus stent approved in us medscape. Pdf resolute integrity drug eluting stent safety and. Clinical outcomes of the resolute zotarolimuseluting stent. Treatment of severe coronary artery disease in a diabetic.
Ccodes are used for hospital outpatient device reporting for medicare and some private payers. Zotarolimus, or abt578, was originally used on abbotts coronary stent platforms to reduce early inflammation and restenosis. Implantation of the tube helps in reducing the constriction of blood flow in the affected region. They ultimately become covered with cells and in essence become part of the artery over time. The medtronic resolute clinical trial the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Medtronic resolute integrity drugeluting stent obtains fda approval for treating coronary artery disease distinguished by superior deliverability and. The resolute integrity drugeluting stent des medtronic was approved for use in the u. With no need for platform improvements, resolute integrity des has treated 2 million patients around the world. Medtronic nets new indications for resolute integrity stent.
Listing a study does not mean it has been evaluated by the u. Engineered for exceptional deliverability, advanced des technology features thinner struts, enhanced visibility and the broadest size matrix in the u. Resolute integrity drug eluting stent safety and efficacy for. You know xience as the worlds leading drugeluting stent des, with an unparalleled safety record.
The resolute onyx stents should not be expanded to a diameter beyond the maximum labeled diameter listed on the label per the ifu. Promus premier flexible stent design boston scientific. May 21, 2012 may 15, 2012 as europcr 2012 gets underway, medtronic inc. Powerful clinical performance across the patient spectrum. Everolimuseluting xience vpromus versus zotarolimus. Can you talk about diabetics and coronary artery disease. Franzjosef neumann at the heart center of bad krozingen in germany enrolled the first patients in resolute u. The drug was solddistributed to medtronic for use on their stent platforms, which is the same drug they use today. Medtronic launches the resolute integrity stent system. Xience v and magnetic resonance imaging examination ap2934652 rev. Resolute integrity zotarolimuseluting coronary stent system. Promus premier stent n15, xience xpedition stent n3, xience v stent n10 and resolute integrity stent n3. New medtronic resolute stent begins process for fda approval. Thank you for your inquiry regarding magnetic resonance imaging mri examinations of patients implanted with the abbott vascular xience v and xience nanotm everolimus eluting coronary stent hereafter referred to as xience v.
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