FDA Approves Medtronic Drug-Coated Balloon for Treating Peripheral Artery Disease in the Upper Leg
Medtronic, Inc. (NYSE: MDT) has announced that the FDA has approved its drug-coated balloon (DCB), the IN.PACT Admiral, for the treatment of peripheral artery disease (PAD) in the upper leg. The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October. The FDA approval of the IN.PACT was supported by a body of clinical evidence of 21 studies involving more than 3,500 patients worldwide, demonstrating the best clinical outcomes of any medical technology for the treatment of PAD in the SFA and popliteal arteries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 7, 2015 Category: Cardiology Source Type: news
Medtronic Drug-Coated Balloon for Peripheral Artery Disease Tops Standard Balloon Angioplasty in Landmark Study
The results of a landmark study published this month in Circulation, the world's leading cardiovascular journal, indicate that a novel medical device from Medtronic, Inc. (NYSE: MDT) called the IN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg -- specifically, the superficial femoral and proximal popliteal arteries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 6, 2015 Category: Cardiology Source Type: news
Philips to Acquire Volcano to Expand Global Leadership Position in Image-Guided Therapy Market
Royal Philips (NYSE: PHG; AEX: PHIA) and Volcano Corporation (NASDAQ:VOLC), a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, today announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Volcano for USD 18.00 per share, or a total equity purchase price of USD 1 billion (approx. EUR 800 million), to be paid in cash upon completion. The board of directors of Volcano has unanimously approved the transaction and recommends the offer to its shareh...
Source: News from Angioplasty.Org - December 17, 2014 Category: Cardiology Source Type: news
Volcano: 1,000 iFR Systems in Use Worldwide
Volcano Corporation (NASDAQ: VOLC) has announced that 1,000 iFR ((instant wave-Free Ratio™) systems have now been activated worldwide. iFR was approved by the U.S. FDA in March of this year and is being used increasingly in cath labs to assist in decision-making (to stent or not to stent and, if so, which blockage is the correct one to stent). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 16, 2014 Category: Cardiology Source Type: news
Excellent Long-Term Outcomes for Endovascular Aneurysm Repair with Medtronic's Endurant AAA Stent Graft
New long-term data from two different studies of Medtronic's Endurant AAA stent graft system reinforce earlier outcomes and demonstrate lasting and consistent results for the endovascular repair of abdominal aortic aneurysms (EVAR). In the U.S. IDE study, 99.2% of patients were free from aneurysm-related mortality and 90% were free from secondary interventions at four years. Similar outcomes were seen In the ENGAGE Registry, even though there were differences in eligibility criteria, including patients with more complex baseline characteristics. (Article includes a video clip about the 1st EVAR performed in 1990.) (Source:...
Source: News from Angioplasty.Org - December 10, 2014 Category: Cardiology Source Type: news
Medtronic Acquisition of Covidien Receives U.S. FTC Clearance
Medtronic, Inc. (NYSE: MDT) and Covidien plc (NYSE: COV) today announced the receipt of U.S. Federal Trade Commission (FTC) clearance of Medtronic's proposed acquisition of Covidien. The FTC's clearance follows Medtronic's and Covidien's agreement to a proposed consent order, which includes a commitment to divest certain assets related to Covidien's drug-coated balloon catheter product. Medtronic's acquisition of Covidien is expected to close in early 2015 after receipt of certain additional regulatory clearances and approvals by both companies' shareholders and sanction by the High Court of Ireland. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 27, 2014 Category: Cardiology Source Type: news
FDA Approves HeartFlow FFR-CT: Non-Invasive Method for Determining Coronary Ischemia
The FDA today approved HeartFlow's FFR-CT software for measuring coronary blockages non-invasively. The current accuracy of FFR-CT to correctly differentiate significant blockages from those not needing revascularization is only in the mid-80% range. Yet the fact that a CT scan can be performed quickly, non-invasively, and with relatively low radiation doses, makes this procedure a significant contender to the extremely common nuclear stress test, and a potential game-changer in the diagnosis of coronary artery disease. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 26, 2014 Category: Cardiology Source Type: news
Supreme Court Justice Ginsburg Receives Stent
This morning Supreme Court Justice Ruth Bader Ginsburg had a stent placed in her right coronary artery (RCA). According to the official statement from the Supreme Court, "The coronary blockage was discovered after Justice Ginsburg experienced discomfort during routine exercise last night and was taken to the hospital. She is resting comfortably and is expected to be discharged in the next 48 hours." (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 26, 2014 Category: Cardiology Source Type: news
One Year Data from the EVOLVE II Trial Shows Safety and Efficacy for Boston Scientific's SYNERGY Bioabsorbable Polymer Stent
One of the last late breaking clinical trials to be presented at this year's American Heart Association Scientific Session may prove to be the pivotal trial of the first bioabsorbable polymer stent technology available to patients in the U.S., if approved by the FDA. Presented by Dr. Dean J. Kereiakes, medical director, The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati, Ohio, the one year data from the EVOLVE II Clinical Trial of Boston Scientific's investigational SYNERGY™ Bioabsorbable Polymer Stent, showed very low rates of target lesion failure (6.4%) and stent thrombosis (0.4%). (So...
Source: News from Angioplasty.Org - November 22, 2014 Category: Cardiology Source Type: news
Encouraging Results for Aorfix AAA Stent Graft from Lombard Medical
Today, a relatively new player in the field, Lombard Medical, announced two year efficacy and safety data on their Aorfix endovascular stent graft system which received FDA approval in 2013 and has been used in more than 4,000 procedures worldwide. The highlights of the data showed 100% freedom from aneurysm rupture, 98% freedom from Type I & III endoleaks and 99% freedom from device migration. In other words, the Aorfix stent graft fixed the problem, rarely developed a leak, and didn't move - all issues that existed with the very first generation of stent grafts, but which have decreased with each iteration of new stent g...
Source: News from Angioplasty.Org - November 20, 2014 Category: Cardiology Source Type: news
DAPT Study: Extended Treatment After Stenting Lowers Stent Thrombosis and Heart Attacks
"Longer is better." That's what Dr. Dean Kereiakis told Angioplasty.Org when characterizing the results of the long-awaited Dual Antiplatelet Therapy (DAPT) study, which were presented today at the annual American Heart Association Scientific Sessions in Chicago. Dr. Kereiakes is the co-principal investigator for this five year study of 10,000 patients, which adds to the knowledge base of whether long-term treatment with aspirin and a thienopyridine, such as Plavix, after stent implantation is beneficial to patients. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 16, 2014 Category: Cardiology Source Type: news
New AAA Stent Graft Approval for Medtronic
Medtronic, Inc. (NYSE: MDT) has announced the U.S. and European approval and launch of its latest stent graft system for the endovascular repair of abdominal aortic aneurysms: the Endurant IIs. This newest iteration of the widely-used Endurant endograft (nearly 1 out of every 2 procedures are done with the Endurant) features a three-piece system with a shorter ipsilateral leg, allowing the device to accommodate more anatomical variations. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 14, 2014 Category: Cardiology Source Type: news
Medtronic Sponsors American Diabetes Association Educational Campaign "Make the Link" for 2nd Year
To help educate people about this connection with heart disease, and provide materials to help with prevention, as well as treatment, Medtronic has announced that it is continuing its sponsorship of the American Diabetes Association's Make the Link! Diabetes, Heart Disease and Stroke initiative for a second year. The "Make the Link" website has a series of downloadable information packets to help educate people about diabetes and coronary artery disease (CAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 14, 2014 Category: Cardiology Source Type: news
5-Year Data for Zilver PTX Drug-Eluting Stent for Leg Arteries Show Continued Efficacy
Following up on the presentation of 4-year data for the Zilver PTX drug-eluting stent at last year's VIVA meeting, Cook Medical today announced the 5-year outcomes - and the results show that patients arteries have remained open, and that there has been no "late catch-up" with the Zilver. While patency was slightly lower at the 5-year mark than at 4-years for both the Zilver and standard balloon due to disease progression and other causes, the divergence between the two therapies actually grew from year 4 to 5, favoring the Zilver. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 5, 2014 Category: Cardiology Source Type: news
Medtronic's IN.PACT Drug-Coated Balloon Shows Safety and Efficacy for Peripheral Angioplasty in Diabetics
Data presented this morning at the VIVA 14 meeting in Las Vegas, Nevada, showed that patients treated with Medtronic's IN.PACT Admiral drug-coated balloon (DCB) for narrowings in their legs above-the-knee had significantly better outcomes than those treated with the standard "plain" balloon catheter, called percutaneous transluminal angioplasty (PTA). While these data were previously presented in April at the Charing Cross international symposium in London, today's session also showed that these positive findings for the DCB held true even for patients with diabetes, a population that typically presents with worse arterial...
Source: News from Angioplasty.Org - November 5, 2014 Category: Cardiology Source Type: news
