New Real-World Comparison Showing Similar Efficacy Between the Lutonix ® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.” (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 10, 2016 Category: Cardiology Source Type: news
New Real-World Comparison Showing Similar Efficacy Between the Lutonix® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.” (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 10, 2016 Category: Cardiology Source Type: news
St. Jude Launches Mobile OCT/FFR/Angio System for Cath Labs in Europe and Japan
St. Jude Medical (NYSE:STJ) recently announced that it has launched a mobile version of its OPTIS™ Integrated System in Japan and Europe. Like its built-in console cousin, the new system, dubbed OPTIS Mobile System, brings together optical coherence tomography (OCT), fractional flow reserve (FFR) and standard angiography. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 9, 2016 Category: Cardiology Source Type: news
FDA Nod to Medtronic MR-Conditional CRT-Defibrillators
The U.S. FDA has cleared the first and only MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure: Medtronic's Amplia and Compia MRI™ Quad CRT-D SureScan® systems. This approval expands Medtronic’s portfolio to include a complete line of MR-conditional cardiac devices, including MR-conditional pacemakers, implantable cardiac defibrillators (ICDs), insertable cardiac monitors (ICMs) and now CRT-Ds. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 5, 2016 Category: Cardiology Source Type: news
FDA OKs Expanded Patient Population for CoreValve
Medtronic plc (NYSE:MDT) announced today that the FDA has revised the IFU (Instructions for Use) labeling for the CoreValve System to now include patients with end-stage renal disease and low flow, low gradient aortic stenosis. Previously, physicians were cautioned in the IFU against treating these patient populations with TAVR because of their severe comorbidities. The FDA's decision was based on positive data from the CoreValve U.S. Expanded Use Study. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 3, 2016 Category: Cardiology Source Type: news
Patient Education About Aortic Stenosis? There's an App for That!
Medtronic, manufacturer of both surgical and percutaneous valves, has developed an easy-to-use iPad app, explaining the disease, its treatment options and, importantly, what happens after discharge from the hospital, when the level of care is reduced and additional support becomes very important. Dubbed the "Aortic Stenosis Patient Journey iPad App," nursing staff, as well as patients and their family, can download this tool from the iTunes store for free. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 26, 2016 Category: Cardiology Source Type: news
Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe
New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year. The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 24, 2016 Category: Cardiology Source Type: news
Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany
Today Mercator MedSystems announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel. Prof. Dr. Dierk Scheinert commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desp...
Source: News from Angioplasty.Org - January 22, 2016 Category: Cardiology Source Type: news
Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease
Medtronic plc (NYSE:MDT) today announced that the IN.PACT® Admiral® drug eluting balloon has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 12, 2016 Category: Cardiology Source Type: news
Medtronic to Build New Plant in Ireland for Manufacturing the IN.PACT Drug-Coated Balloon
This week, Medtronic announced that it was investing $14 million to build a new 20,000 sq. ft. plant in Galway, Ireland, specifically to manufacture the IN.PACT drug-coated balloon. This project is a direct outgrowth of Medtronic's merger with Ireland-based Covidien, a company which had its own DCB, the Stellarex, which was sold off to Spectranetics as part of the requirements for the merger. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 17, 2015 Category: Cardiology Source Type: news
Svelte's Stent-on-a-Wire Gains CE Mark
Svelte Medical Inc., a relatively small device manufacturer based in New Jersey today achieved a milestone: the CE Mark approval that will allow the company to commercialize its novel stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte hopes to submit a PMA application to the FDA in 2016. The approval was based mainly on the results of the DIRECT II study of 189 patients which showed no stent thrombosis at four years and efficacy, measured by target vessel failure and in-stent late loss, at least as good as the standard drug-eluting stents currently on the market. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 16, 2015 Category: Cardiology Source Type: news
Scripps Cardiologists Eric Topol and Paul Teirstein To Participate in Book Signing at TCT on Oct. 14
Noted Scripps Clinic cardiologists Eric Topol, M.D., and Paul Teirstein, M.D., will sign copies of their newly released 7th Edition of “Textbook of Interventional Cardiology,” an indispensable resource for clinicians who need a guide to interventional procedures. The signing will take place during the 27th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium at the Scripps Health Exhibition Booth #2524 in Moscone Center, South Hall, San Francisco, Wednesday, October 14, from 12:45pm - 1:45 pm. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 13, 2015 Category: Cardiology Source Type: news
Medtronic's Drug-Filled Stent: First Data
Called a DFS ("drug-filled stent") it is both a drug-eluting stent AND a bare metal stent, utilizing the same 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 laser-drilled holes in the metal outer core. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 13, 2015 Category: Cardiology Source Type: news
Medtronic Acquires Medina Medical
Medtronic plc (NYSE:MDT) today announced it has acquired Medina Medical, a Menlo Park, Calif.-based and privately-held medical device company focused on commercializing state-of-the-art treatments for vascular abnormalities of the brain including cerebral aneurysms. This acquisition is another example of the company's commitment to its key growth strategy of therapy innovation. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 9, 2015 Category: Cardiology Source Type: news
FDA Approves Expanded Indication for AstraZeneca Medications to Include Long-Term Use in Patients with a History of Heart Attack
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved BRILINTA® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 3, 2015 Category: Cardiology Source Type: news
