Medtronic (NYSE:MDT) today touted data demonstrating reductions in reinterventions and complications with its Micra pacemaker. Fridley, Minn.-based Medtronic’s Micra Coverage with Evidence Development (CED) study, which it labeled the largest evaluation of leadless pacemakers to date, showed that the Micra transcatheter pacing system (TPS) was associated with a 38% reduction in reinterventions and a 31% […]
Cardiovascular
SVB Leerink analysts expect Abbott to gain share on Boston Scientific’s Watchman
Analysts believe Abbott (NYSE:ABT) may gain traction on Boston Scientific’s (NYSE:BSX) Watchman in the left atrial appendage closure (LAAC) space. The second LAAC survey commissioned by SVB Leerink, which compared information from electrophysiologists to information from interventional cardiologists in the previous survey, pointed to the deceleration of Watchman volume expectations from double-digit growth in 2021-2022 […]
How iRhythm sought to outdo the old-school Holter monitor
iRhythm is changing the game in a heart rhythm monitoring space that has been dominated for years by the Holter Monitor. Here’s how. About 14 years ago, when Mark Day was interviewing at iRhythm, he could see the unmet needs that a project out of Stanford’s Biodesign program addressed. While that was a start, there […]
3 pitfalls to consider when creating catheter delivery systems
Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls. A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on […]
Design considerations you need to know when making ablation catheters to treat AFib
Catheters are increasingly deploying heart devices in minimally invasive procedures. CardioFocus VP of engineering Jerry Melsky describes the components and design considerations that go into making successful ablation catheters to treat AFib. Atrial fibrillation (AFib) is the most common irregular heart rhythm disorder. If the atria of the heart beats rapidly and irregularly, blood does […]
FDA approves Medtronic next-gen Evolut FX TAVR system
Medtronic today announced that its Evolut FX TAVR system has won FDA approval. Fridley, Minn.–based Medtronic designed the self-expanding transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis. Get the full story on our sister site, Medical Tubing + Extrusion.
Q’Apel Medical launches Armadillo radial access catheter
Q’Apel Medical this week announced that its Armadillo radial access system won FDA 510(k) clearance. Fremont, Calif.-based Q’Apel Medical designed the Armadillo to help physicians move from femoral artery access to radial artery access. The company’s radial platform of access catheters is specifically designed to address challenges associated with radial access. Get the full story […]
How Medtronic fit a battery into a tiny pacemaker
Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device. It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via […]
FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump
Abiomed (NSDQ:ABMD) today announced that the FDA has granted breakthrough device designation for its Impella ECP expandable percutaneous heart pump. Danvers, Mass.-based Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the body. It expands in the heart […]
Sinomed launches HT Supreme drug-eluting stent in Europe
Sinomed has completed the first commercial implantation of its HT Supreme drug-eluting stent in Ireland. Faisal Sharif, professor of translational cardiovascular medicine and innovation at the National University of Ireland Galway, successfully performed the first procedure with HT Supreme, a healing-targeted drug-eluting stent designed to treat patients with narrowing or blockages to their coronary arteries. Get […]
FDA approves Abbott Amplatzer Amulet to reduce stroke risk for AFib patients
Abbott today announced that it has received FDA approval for its Amplatzer Amulet device for people with atrial fibrillation. The Amplatzer Amulet is a left atrial appendage occluder to reduce ischemic stroke risk for people with atrial fibrillation (AFib). The device is a small pouch connected to the upper left chamber of the heart. AFib […]
