Medtronic CoreValve® System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the CoreValve® System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The CoreValve System is the first transcatheter heart valve approved in the U.S. for VIV procedures in both high and extreme risk patients who have limited options or may otherwise go untreated. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 11, 2015 Category: Cardiology Source Type: news
Medtronic Announces Japanese Regulatory Approval of CoreValve® System
Medtronic plc (NYSE: MDT) today announced Japanese regulatory approval for the self-expanding transcatheter CoreValve® System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with the CoreValve is determined to be the best option. Japanese regulatory authorities granted approval of the CoreValve system for transcatheter aortic valve implantation (TAVI) based on robust data from the CoreValve U.S. Pivotal Trials and the Medtronic CoreValve Japan Trial, which is the first study to evaluate a self-expandable transcatheter valve in the Japanese patient population. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 11, 2015 Category: Cardiology Source Type: news
Philips Appoints Healthcare Industry Veteran Robert Cascella to Lead Its Cluster of Global Imaging Businesses
Royal Philips (NYSE: PHG, AEX: PHIA) today announced the appointment of Mr. Robert Cascella to lead Philips' multi-billion euro cluster of Imaging businesses. These businesses capitalize on the rapidly transforming global healthcare industry, in particular in the areas of integrated diagnostic imaging and image-guided minimally invasive therapy solutions. He succeeds Gene Saragnese, who has decided to retire from Philips per May 1, 2015. Mr. Cascella will hold the title of Executive Vice President, Royal Philips. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 10, 2015 Category: Cardiology Source Type: news
Volcano Receives CE Mark for iFR Scout Pullback Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease
Royal Philips (NYSE: PHG; AEX: PHIA), today announced that Volcano, a Philips business, has received CE Mark for the iFR Scout pullback software, a functional extension of its existing iFR Modality, optimized to assess serial lesions and diffuse coronary disease. Limited Market Release will commence immediately at leading European and Japanese medical centers. This software is currently pending 510(k) clearance at the US FDA. It is not available for sale in the US. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 10, 2015 Category: Cardiology Source Type: news
Medtronic CoreValve® Evolut™ R System Yields Exceptional Outcomes in First Clinical Study
Medtronic plc (NYSE: MDT) today announced initial clinical outcomes for its next-generation CoreValve® Evolut™ R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology (ACC.15) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 9, 2015 Category: Cardiology Source Type: news
Medtronic CoreValve® System Sustains Superior Survival Benefit Over Open Heart Surgery at Two Years
Medtronic plc (NYSE: MDT) today unveiled new, highly anticipated two-year data from the High Risk Study of the CoreValve U.S. Pivotal Trial, which continued to show superior survival benefit at two years for transcatheter aortic valve replacement (TAVR) with the CoreValve® System compared to patients who underwent surgical aortic valve replacement (SAVR). The CoreValve US Pivotal High Risk Study is the first and only head-to-head study to show statistically significant survival differences favoring TAVR in aortic stenosis patients who are considered high risk for surgery. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 9, 2015 Category: Cardiology Source Type: news
ACC Reacts to CMS' Proposed Rule for Meaningful Use Stage 3
American College of Cardiology President Kim Allan Williams Sr., M.D., FACC, released the following statement on today's announcement by the Centers for Medicare & Medicaid Services regarding Meaningful Use Stage 3: "The American College of Cardiology has long supported the adoption of electronic health records (EHRs) as a mechanism for improving patient outcomes. The EHR Incentive Program as currently structured has been focused more on 'checking the box' than changing care delivery to achieve the goal of improved patient care. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 21, 2015 Category: Cardiology Source Type: news
Medtronic Begins Testing a "Drug-Filled Stent"
Today Medtronic announced the first study of a novel stent concept, the "drug-filled stent" or DFS. It is both a drug-eluting stent AND a bare metal stent, utilizing a stent construction that Medtronic currently uses in its Resolute Integrity and Onyx stents. The stent is fashioned from a single strand of metal that can have several "inner cores." In the DFS, the drug is contained in a reservoir, inside the stent, and slowly eluted through small holes in the metal outer core. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 14, 2015 Category: Cardiology Source Type: news
Medtronic Begins Trial for Next-Generation Drug-Eluting Stent in Small Arteries
Today Medtronic plc (NYSE: MDT) announced that it is beginning the U.S. pivotal trial for its new drug-eluting stent, the Resolute Onyx™. The Onyx received the European CE Mark in November and has been available in countries that recognize the CE Mark. The first phase of this trial will be studying one of the most challenging clinical scenarios: blockages in arteries that measure as small as 2.0mm. Normally drug-eluting stents are not used in arteries this narrow because of the increased incidence of stent thrombosis and restenosis. But the Onyx has thinner struts than the first and second generation DES devices and has ...
Source: News from Angioplasty.Org - March 12, 2015 Category: Cardiology Source Type: news
Society of Cardiovascular Computed Tomography (SCCT) Names Norm Linsky New Executive Director
The Society of Cardiovascular Computed Tomography (SCCT) Board of Trustees today announced that Norm Linsky, MPA, MA has been selected as the Society's new Executive Director. Linsky comes to SCCT from the Society for Cardiovascular Angiography and Interventions (SCAI), where as Executive Director for 14 years he partnered with physician volunteers to dramatically increase SCAI's membership, educational programs, advocacy efforts, guidelines and international partnerships. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 28, 2015 Category: Cardiology Source Type: news
CMS Approves Pass-Through Payment for Lutonix DCB for Outpatient Use
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for C. R. Bard's Lutonix® drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 26, 2015 Category: Cardiology Source Type: news
Medicare Approves Transitional Pass-Through Payment for Outpatient Use of Medtronic Drug-Coated Balloon
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for Medtronic's IN.PACT Admiral drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system (OPPS), removing a potential barrier to patient access to this new medical device, which represents a significant improvement to the standard of care for peripheral arterial disease in the upper leg. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 26, 2015 Category: Cardiology Source Type: news
The American Heart Association - American Stroke Association and Medtronic Collaborate to Reduce Recurrent Strokes
The American Heart Association/American Stroke Association (AHA/ASA) and Medtronic plc (NYSE: MDT), today announced a collaboration to reduce the rate of recurrent strokes in the U.S. The two organizations will work together over several years to educate, raise awareness and support effective management of patients who have strokes, one of the most devastating diseases affecting Americans today. The initiative, announced at the American Stroke Association's annual International Stroke Conference in Nashville, Tennessee, will focus on reducing strokes of unknown cause, called "cryptogenic stroke." (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 19, 2015 Category: Cardiology Source Type: news
Philips Acquisition of Volcano Completed
As expected, Royal Philips (NYSE: PHG; AEX: PHIA) today completed its acquisition of San Diego-based Volcano Corporation, making Philips the only manufacturer of cardiovascular imaging systems to offer both angiographic (X-ray) and intravascular imaging and guidance options. The combination of Volcano's IVUS and FFR technology, along with Philips long-standing leadership in the interventional imaging field, promises to bring wider distribution of image-guided therapies. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 18, 2015 Category: Cardiology Source Type: news
Medtronic Gains CE Mark for Euphora Semicompliant Coronary Balloon; Launches in Europe
Today Medtronic plc (NYSE: MDT) announced that its Euphora™ Semicompliant Balloon Dilatation Catheter has received the CE (Conformité Européene) mark and that the product has been launched, the first case being performed by Dr. Richard Edwards in the UK. While most think of stents when they think of interventional cardiology, balloons play an important role in percutaneous coronary interventions (PCI). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 17, 2015 Category: Cardiology Source Type: news
