Abbott Laboratories had a busy Transcatheter Cardiovascular Therapeutics (TCT) 2019 conference. Among the news it generated was the unveiling of new analyses of the COAPT trial on the cost-effectiveness of Mitraclip vs. guideline-directed medical therapy (GDMT) alone in heart failure patients with secondary mitral regurgitation (MR).
SAN FRANCISCO – Abbott Laboratories expects that its self-expanding transcatheter aortic valve replacement (TAVR) system Portico will be able to become a top competitive product. A pivotal trial of Portico has found that the implant is noninferior to current FDA-approved TAVR systems that are marketed in the U.S. The results from the 750-patient, randomized trial were presented here last week at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
SAN FRANCISCO – Mitraclip from Abbott Park, Ill.-based Abbott Laboratories, has long been the only minimally invasive mitral valve repair device that's approved by the FDA. Edwards Lifesciences Corp., of Irvine, Calif., aims to challenge that dominance with its Pascal. This week at the Transcatheter Cardiovascular Therapeutics (TCT) conference, positive one-year data from the small CLASP study on Pascal were presented, offering a further glimpse of data for comparison.
BOSTON – The shift to value-based care models and rise in digital technologies is causing medical device companies to rethink how and where they invest in innovation. There's less emphasis on core and adjacent product investments and more focus on transformational advances that don't just add new bells and whistles but expand access, improve outcomes and lower costs. Just what that looks like and how companies are adapting to this new innovation landscape was the focus of a session at the Medtech Conference this week.
The recent progress in interventional cardiology has largely been driven by the aortic valve, although calcification of the aortic root has proven a difficult hurdle to overcome. A newly published study demonstrates that the Tendyne device by Abbott Vascular Inc., of Santa Clara, Calif., can be readily used not just to treat failing mitral valves, but works well in these patients with severe calcification, an achievement that could quickly vault the transcatheter approach past conventional surgical approaches in this population.
Abbott Laboratories has kicked off a pivotal study to evaluate its catheter-based Triclip transcatheter tricuspid valve repair system in patients with severe tricuspid regurgitation (TR). The first enrollments in the U.S. FDA-approved Triluminate study were performed at Abbott Northwestern Hospital in Minneapolis by a cardiac team led by Paul Sorajja, director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute and co-primary investigator for the trial.
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.
