New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
Dual presentations, made at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 2, 2018 Category: Cardiology Source Type: news
FDA OKs IN.PACT ™ Admiral™ Drug Coated Balloons of 200mm and 250mm Lengths
A subset of Medtronic's IN.PACT Global Study analyzed very long lesions in the SFA of over 180mm (7 inches), including cases of in-stent restenosis (ISR) and chronic total occlusions (CTO). The one-year results showed patency of 89.1% and clinically-driven target lesion revascularization at 7.1%. As a result of these findings, in April the FDA approved the IN.PACT DCB for treatment of long lesions. And last week, the FDA approved two new long length IN.PACT balloons (200mm and 250mm) that will become an important part of the armamentarium, implementing the April long lesion approval. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 23, 2018 Category: Cardiology Source Type: news
Interview with Yusuke Yoshikawa, MD
Dr. Yoshikawa discusses his study, just published in Circulation, titled "Validating Utility of DAPT Score in a Large Pooled Cohort from Three Japanese PCI Studies," and he comments on how the Japanese population differs from western patients in terms of bleeding and ischemic event rates. (posted in collaboration with TCROSS NEWS) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 10, 2017 Category: Cardiology Source Type: news
Complex CTO-PCI: The Japanese Approach
This 20 minute video shows a complex CTO case, in which an RCA obstruction, complicated by a sharp bend and tortuous anatomy, was revascularized using both the antegrade and retrograde approaches, facilitated by IVUS and biplane angiographic imaging. The operator is Dr. Etsuo Tsuchikane; the case was broadcast live during the Japanese CTO Club course in June 2017. (posted in collaboration with TCROSS NEWS) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 31, 2017 Category: Cardiology Source Type: news
Medtronic's Evolut PRO Now Available in Europe
Medtronic has announced that its latest transcatheter aortic valve, the CoreValve Evolut PRO, has received the CE mark and is now available for use in Europe. In a reversal of the usual order of device approvals, FDA approval pre-dated the CE Mark - the Evolut PRO was first given an FDA okay back in March. This new generation valve utilizes a biocompatible porcine outer wrap that increases surface contact and sealing to reduce paravavular leaks (PVL). Another major improvement over earlier iterations was the reduced necessity for permanent pacemaker implantation: only 10% in this cohort. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 31, 2017 Category: Cardiology Source Type: news
Clinical Trial to Study If 3-Months of DAPT is Safe After XIENCE Stent
The study, called XIENCE Short DAPT, will evaluate if 3 months of DAPT is non-inferior to the current standard of 12 months after implantation with a XIENCE stent for patients who are at high risk of bleeding. The study will enroll approximately 2,000 patients at 100 sites in the U.S. and Asia. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 26, 2017 Category: Cardiology Source Type: news
FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement
Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality>= 3% at 30 days. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 10, 2017 Category: Cardiology Source Type: news
Barriers to Achieving Optimal Door-to-Balloon Time in Japan: Interview with Dr. Shun Kohsaka
In this interview, co-author Dr.Shun Kohsaka of the Department of Cardiology at Keio University School of Medicine in Tokyo, Japan, discusses a study, recently published in the Japanese Circulation Society's Circulation Journal, demonstrating that door-ro-balloon time in half of STEMI cases in Japan is greater than 90 minutes.(Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 30, 2017 Category: Cardiology Source Type: news
Prognostic Impact of Revascularization in Poor-Risk Patients with Critical Limb Ischemia: Interview with Dr. Osamu Iida
Dr. Iida was principal investigator for the PRIORITY registry, testing whether revascularization impacted survival at one-year for poor-risk-CLI patients. The study was published in the June 12 issue of JACC: Cardiovascular Interventions and looked at over 600 patients in 37 hospitals across Japan. (Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 18, 2017 Category: Cardiology Source Type: news
Medtronic Receives FDA Approval for CoreValve ™ Evolut™ Pro Transcatheter Valve with Advanced Sealing
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve ™ Evolut™ PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Sessio n, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 22, 2017 Category: Cardiology Source Type: news
First U.S. Case Done with Tryton's Side Branch Stent
Earlier this month, the FDA approved Tryton Medical's Side Branch Stent and today, at New York-Presbyterian Hospital/Columbia University Medical Center in New York, the first case was performed by two of the leading interventional cardiologists in the U.S., Dr. Martin Leon and Dr. Ajay Kirtane. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 22, 2017 Category: Cardiology Source Type: news
Medtronic's Micra Leadless Pacemaker Approved for Reimbursement in U.S.
In a big leap forward for the use of leadless pacemakers, U.S. Centers for Medicare& Medicaid Services (CMS) today approved reimbursement coverage for Medtronic's Micra ® Transcatheter Pacing System (TPS), the only FDA-approved leadless pacing system. A major advantage of leadless pacemakers is that they can be implanted via catheter, in a similar fashion to angioplasty, so no surgical incision or pocket is necessary. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 11, 2017 Category: Cardiology Source Type: news
Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology
This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This is an investigational device, which uses Medtronic's unique IN.PACT ™ Admiral™ drug coating technology. The study will enroll approximately 60 patients at four sites in Europe. The primary endpoint is late lumen loss at nine months. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 9, 2017 Category: Cardiology Source Type: news
New Analysis of Reverse Trial Shows Medtronic CRT Devices Cost-Effective, While Helping Patients with Mild Heart Failure Live Longer
Medtronic plc (NYSE:MDT) today announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer and that implanting these devices is cost-effective, compared to optimal medical therapy. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 6, 2017 Category: Cardiology Source Type: news
Interview with Yukata Tanaka, MD, PhD
Dr. Yutaka Tanaka discusses his group's study on transradial coronary interventions for complex chronic total occlusion, just published in JACC: Cardiovascular Interventions. The patient population for this single-center study comprised almost 600 patients and looked at whether the transradial approach was feasible for complex chronic total occlusions. (Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 22, 2017 Category: Cardiology Source Type: news
