Abbott has announced that the Xience Prime and the Xience V everolimus-eluting coronary stent systems have received CE Mark in Europe for the use of dual antiplatelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease. This is the shortest duration of DAPT for any major drug eluting stent (DES) in Europe.
LAS VEGAS—When treating a real-world sample of patients for intermittent claudication or critical limb ischemia, two off-label iliac artery stents showed a statistically significant performance goal for low major adverse event rates, according to the late breaking MOBILITY trial results presented May 10 at the 35th annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI). During the press conference, experts suggested that this study may further reinforce the role of percutaneous treatments over the more invasive surgical option for these sick patients.
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| Source: ECRI Institute |
The medical device industry enjoys a favorable reputation among a majority of patient groups around the world, although perceptions of its performance in particular areas of activity add up to a mixed bag.
Abbott has entered into an agreement to acquire AP214 from Action Pharma, a privately owned company based in Aarhus, Denmark, for $110 million.
Sirolimus-eluting stents (SES) proved to be more effective than cutting balloon angioplasty for treatment of drug-eluting stent (DES) in-stent restenosis for focal lesions and are comparable to everolimus-eluting stents for treatment of diffuse DES in-stent restenosis, according to a study published March 20 in the Journal of the American College of Cardiology.
The FDA has issued updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) known as protease inhibitors and certain statins, because, if taken together, they may raise the blood levels of statins and increase the risk for muscle injury, or myopathy.
Physicians will have another option when it comes to treating patients with coronary artery disease—Medtronic’s Resolute Integrity Drug-Eluting Stent (DES). FDA approved the device Feb. 20.
WASHINGTON, D.C.—The 2.25 mm Promus Element everolimus-eluting stent demonstrated safety and effectiveness in the PLATINUM Japan Small Vessel (SV) study, presented Feb. 6 at the Cardiovascular Research Technologies (CRT) meeting.
ORLANDO, Fla.—AIM-HIGH, a late-breaking clinical trial presented at this year’s American Heart Association (AHA) scientific sessions, received a great deal of criticism for its design from its discussant, Philip Barter, MD, PhD; however, lead investigator William E. Boden, MD, strongly defended the design, even though he acknowledged to
Cardiovascular Business that the results of the prematurely stopped trial will not change practice.
Abbott’s cholesterol drug fenofibrate (Trilipix) has made news again after the FDA put out a drug safety communication statement warning the public that the drug may not be all it's cracked up to be in terms of lowering a patient’s risk of MI or stroke. These data are based on the ACCORD Lipid trial, which evaluated the safety of fenofibrate plus simvastatin combination therapy versus simvastatin (Zocor, Merck Pharmaceuticals) alone in diabetic patients.
The large-scale ADAPT-DES registry, which assessed platelet reactivity with a variety of platelet function tests in more than 8,500 patients, reaffirmed that the tests have not found an appropriate place in routine clinical practice. The study was presented Nov. 9 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
SAN FRANCISCO—In a head-to-head comparison, the Resolute zotarolimus-eluting stent (Medtronic) and Xience V everolimus-eluting stent (Abbott Vascular) performed almost identically in terms of safety and efficacy for treating patients with complex lesions, according to data from the TWENTE trial presented at a late breaking clinical trial session Nov. 11 at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference.
SAN FRANCISCO—The incidence of non-adherence to dual-antiplatelet therapy (DAPT) was 2 percent at 30-days of follow-up, based on the “real world” international observational PARIS registry, presented Nov. 9 as a late-breaking clinical trial at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
SAN FRANCISCO—When diabetic patients were treated with either the Resolute zotarolimus-eluting stent or Xience V everolimus-eluting stent, they saw similar one-year outcomes, Sigmund Silber, MD, director of the Heart Centre at the Isar in Munich, presented Nov. 8 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Additionally, even in non-insulin dependent diabetes patients treated with the Resolute stent, clinical outcomes were similar to those outcomes seen in the non-diabetic population.
Abbott has received FDA approval for the next-generation Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease.
Wireless patient monitors are outpacing their predicted growth, according to market research firm Kalorama, which reported a growth rate of 23 percent between 2008 and 2010. Revenues have doubled in the last four years, making wireless monitors the fastest growing device category, and are expected to double again over the next four years.
In late 2009, Aspirus Heart & Vascular Institute in Wausau, Wis., was inspired to develop a dedicated heart valve center, in conjunction with a Valve Clinic, by both clinical and economic motivations. Since that time, the provider has seen an increase in referrals for surgical valve candidates, while also building in-house expertise of the complex disease states.
Abbott will separate into two different publicly traded companies: the medical product manufacturer will split into a diversified medical products company and the other company will be focused on research-based pharmaceuticals.
Abbott has received FDA approval for its RX Herculink Elite renal stent system for the treatment of renal artery stenosis in patients with uncontrolled hypertension. Over time, narrowed kidney arteries can lead to kidney failure and increased risk of heart disease, stroke and peripheral artery disease.
One hundred cardiologists surveyed about companies that have had the greatest impact in the field of cardiology placed Pfizer, AstraZeneca, Johnson & Johnson, Merck and Sanofi-Aventis at the top. Additionally, cardiologists said that atorvastatin (Lipitor), clopidogrel (Plavix) and carvedilol (Coreg) yielded the best patient outcomes, reported Sermo Client Solutions, which released the results of its survey Aug. 3.
