Abbott (NYSE:ABT) is claiming a big win for its Amplatzer Amulet device in a head-to-head trial with Boston Scientific’s (NYSE:BSX) Watchman. Late-breaking data presented at the European Society of Cardiology Congress and simultaneously published in Circulation support the FDA’s recent approval for the Amplatzer Amulet, Abbott said in a news release. The Amplatzer Amulet Left Atrial […]
Cardiac Implants
Medtronic touts real-world data for Micra leadless pacemaker
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% […]
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 […]
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 […]
ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD
A recent ProPublica report highlighted potential failings by the FDA in the handling of Medtronic’s HVAD system. In June, Medtronic stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system amid a slew of clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. The company had previously recalled […]
Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent
Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
Abbott launches latest insertable cardiac monitor
Abbott (NYSE:ABT) announced that it launched the Jot Dx — its latest insertable cardiac monitor (ICM) — in the U.S. Jot Dx offers clinicians and hospitals control of the management of the flow of information through a feature that allows the viewing of abnormal heart rhythm data. It can simplify which irregular heart rhythms are […]
Edwards Lifesciences beats The Street in Q2, boosts guidance
Edwards Lifesciences (NYSE: EW) reported second-quarter results this evening that beat the consensus forecast on Wall Street — and raised its 2021 guidance in the process. The Irvine, Calif.–based cardio device company reported earnings of $489.5 million, or 78¢ per share, off sales of $1.376 billion – a turnaround from the loss of –$121.9 million, […]
FDA clears Medtronic’s AI algorithms for cardiac monitoring
Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use with the Linq II ICM. Fridley, Minn.–based Medtronic’s AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by the Linq II insertable cardiac monitor (ICM) to improve the information provided to physicians for better diagnoses and treatments […]
Boston Scientific touts Watchman FLX trial data
Boston Scientific (NYSE:BSX) today touted positive 24-month results from a trial evaluating its Watchman FLX left atrial appendage closure device. Marlborough, Mass.-based Boston Scientific’s Watchman FLX LAAC device for patients with non-valvular atrial fibrillation (NVAF) had previously proven its safety and efficacy in 12-month data from the same trial presented in April. The latest data, […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
