Edwards Lifesciences Comments on U.S. Appeals Court Order
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Court of Appeals for the Federal Circuit today issued a stay for the preliminary injunction that was ordered on April 11 to limit the sale of Medtronic's CoreValve system in the United States. Today's order postpones the implementation of the preliminary injunction. It does not reverse the federal jury's finding of Medtronic's willful infringement, for which all appeals have been exhausted, and does not affect the determination of additional damages. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 22, 2014 Category: Cardiology Source Type: news
Federal Appeals Court Agrees to Medtronic Request to Postpone Injunction
The Federal Circuit Court of Appeals today granted a request from Medtronic, Inc. (NYSE: MDT) to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve® System in the United States. This means the injunction will only take effect if the appellate court determines the injunction was properly issued. In addition, last week the Court of Appeals agreed to an expedited appeal of the injunction ruling, with the last appeal brief to be submitted by June 19. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 21, 2014 Category: Cardiology Source Type: news
Update on CoreValve Federal District Court Ruling; Court Agrees to Expedited Appeal
Medtronic, Inc. (NYSE: MDT) today issued an updated statement on the recent ruling by Federal District Court of Delaware. Medtronic has asked the U.S. Circuit Court of Appeals to postpone the injunction until it can determine if the injunction was properly issued. The Court has not yet ruled. Medtronic also requested, and the Court agreed to, an expedited appeal of the injunction ruling, and other underlying legal issues, with the last appeal brief to be submitted by June 19. Medtronic does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunctio...
Source: News from Angioplasty.Org - April 20, 2014 Category: Cardiology Source Type: news
Volcano Corporation Schedules First Quarter Conference Call, Webcast
Volcano Corporation (Nasdaq:VOLC) announced that it will report its operating results for the first quarter of fiscal 2014 on Friday, May 2. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 pm, Pacific Daylight Time (5 pm, Eastern Daylight Time), Friday, May 2, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 17, 2014 Category: Cardiology Source Type: news
Valve Wars, Part III: Edwards vs. Medtronic
Another volley across the bow in the ongoing heart valve wars was served up Friday, when the U.S. District Court for the District of Delaware granted Edwards Lifesciences (NYSE: EW), the manufacturer of the Sapien transcatheter aortic valve, a preliminary injunction that will limit Medtronic's (NYSE: NDT) sales of its competing CoreValve system in the United States. Barring further rulings, the injunction will go into effect on April 22. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 14, 2014 Category: Cardiology Source Type: news
FDA Approves Start of Trial for Cobra PzF™ Stent
A clinical trial for a novel concept coronary stent will soon start enrolling patients in the United States: the COBRA PzF™ coronary stent system was given an investigative device exemption (IDE) by the FDA last month and will shortly begin recruiting at 14 U.S. hospitals; 13 outside U.S. sites have already started the process. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 11, 2014 Category: Cardiology Source Type: news
Abbott's Absorb Bioresorbable Scaffold Completes Enrollment in 3 Pivotal Clinical Trials
Today, Abbott announced that it has completed enrollment of not one, but three pivotal clinical trials to support approval of the Absorb BVS in the United States, Japan, and China, three countries that comprise 50% of the global market for stents. The trials pit the Absorb Bioresorbable Vascular Scaffold against Abbott's flagship everolimus-eluting XIENCE stent in almost 3,000 patients worldwide. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 10, 2014 Category: Cardiology Source Type: news
Medtronic CoreValve® System Demonstrates Long-Term Durability
The Study results showed the long-term durability and excellent clinical performance of the CoreValve System with no incidences of structural valve dysfunction at four years. The study also showed significant improvements in quality of life at one year which were sustained through four years, with 74 percent of patients improving at least one New York Heart Association (NYHA) functional class from baseline to four years. Additionally, the rates of regurgitation and stroke remained low, with 83.0 percent of patients free from stroke at four years follow-up. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 31, 2014 Category: Cardiology Source Type: news
Robot Stent Placement in the Cath Lab
Angioplasty and stent placement is the gold standard for the emergency treatment of heart attacks. But getting the patient to a catheterization lab where the angioplasty can be performed in a timely fashion has been a challenge. Now, Corindus Vascular Robotics is testing a new solution, whereby an interventional cardiologist may be able to perform an angioplasty and precisely place a stent -- from another city! (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 31, 2014 Category: Cardiology Source Type: news
Medtronic Global SYMPLICITY Registry Shows Strong Safety Profile of the Symplicity™ Renal Denervation System
Medtronic, Inc. (NYSE: MDT), announced today further analysis of six-month follow-up data from the first 1,000 patients enrolled in the Global SYMPLICITY Registry, which continue to demonstrate the safety of the Symplicity™ renal denervation system. The results of this observational, open-label study show that renal denervation with the Symplicity™ renal denervation system resulted in significant reductions in both office and 24-hour ambulatory blood pressure compared to baseline, with very low adverse event rates to six months. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 30, 2014 Category: Cardiology Source Type: news
Boston Scientific LOTUS™ Valve System Demonstrates Sustained Safety and Efficacy Outcomes at Three Months
The REPRISE II clinical trial, evaluating the Lotus™ Valve System in symptomatic patients with severe aortic valve stenosis and considered at high risk for surgical valve replacement, demonstrated favorable safety and efficacy outcomes out to three months with 85 percent of patients having no paravalvular aortic regurgitation (leaking). The data were presented by Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 30, 2014 Category: Cardiology Source Type: news
Medtronic CoreValve® System Results Superior to Open-Heart Surgery at One Year in U.S. Pivotal Trial
Medtronic, Inc. (NYSE: MDT) today announced that the CoreValve® System showed results superior to surgical aortic valve replacement (SAVR) at one year in the High Risk Study of its CoreValve U.S. Pivotal Trial, which evaluated patients with severe aortic stenosis who are considered high risk for surgery. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 30, 2014 Category: Cardiology Source Type: news
Medtronic Releases Results of SYMPLICITY HTN-3
Medtronic, Inc. (NYSE: MDT) today announced the full results of the SYMPLICITY HTN-3 clinical trial, which were presented today at the 63rd Scientific Sessions of the American College of Cardiology (ACC) and published simultaneously in The New England Journal of Medicine. SYMPLICITY HTN-3, the first and only blinded, randomized, sham controlled study of renal denervation for treatment-resistant hypertension, met its primary safety endpoint but did not meet its primary or secondary efficacy endpoints. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 30, 2014 Category: Cardiology Source Type: news
FDA Approves Volcano's iFR® Pressure Measurement Modality for Use in Coronary Stent Guidance
This morning Volcano Corporation announced that the U.S. Food and Drug Administration has granted approval to the company's proprietary coronary pressure measurement modality, iFR (Instant wave-Free Ratio). iFR represents a significant advance in the field of functional measurement (FM), in which the actual flow pressures inside the coronary artery can be measured and the deficit caused by a coronary blockage or lesion can be accurately assessed. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 19, 2014 Category: Cardiology Source Type: news
Boston Scientific Gets European Approval for the REBEL: a "New" Bare Metal Stent
Take away the everolimus-eluting polymer from Boston Scientific's FDA-approved Promus PREMIER™ stent and what do you have? The REBEL bare metal stent, which just received CE Mark approval last week and is now available for the European market. REBEL is probably a good name for this device, in that it "rebels" against the historical norm, wherein a bare metal stent platform first gets approved for safety and efficacy, and only then gets coated with a drug-eluting polymer, is tested in clinical trials, gets CE Mark approval and finally FDA approval. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 18, 2014 Category: Cardiology Source Type: news
