BTG (LSE: BTG) today announced the first successful implantation of its Sentry bioconvertible inferior vena cava (IVC) filter in patients outside of a clinical trial. The Sentry device won FDA 510(k) clearance in 2017. London-based BTG acquired the device in September through its purchase of Galway, Ireland–based Novate. Get the full story on our sister site Medical […]
Micro Interventional Devices touts early results in tricuspid repair trial
Micro Interventional Devices last week touted early results from a study of its minimally invasive annuloplasty technology as a treatment for severe tricuspid regurgitation. The technology has been successfully implanted percutaneously in four patients, the company reported. Get the full story at our sister site, Medical Design & Outsourcing.
Medtronic studies use of both heat and cold for cardiac ablation
Medtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment. The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing […]
J&J’s Biosense Webster launches Heliostar multi-electrode ablation cath trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study. The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation. The […]
FDA clears Innovative Health to reprocess major manufacturers’ catheters
Innovative Health said it has nabbed FDA clearances to reprocess diagnostic catheters made by St. Jude Medical, Medtronic and Biosense Webster. The catheters include St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s Decanav. Innovative Health said it is the first in the industry to receive clearances to reprocess the Advisor and the Decanav, […]
Millar ends CD Leycom distribution agreement
Millar said today that it is discontinuing its exclusive North American distribution agreement with CD Leycom, maker of the clinical Inca pressure-volume (PV) loop system. Officials at Houston-based Millar – a pressure sensors and medical device contract manufacturing company – plan to focus more on the company’s OEM division, which integrates pressure sensors based on microelectromechanical systems […]
BioSig inks Pure EP first-in-human study deal with Texas Cardiac Arrhythmia Institute
BioSig Technologies (OTCQB: BSGM) said today that it inked a deal with Austin’s Texas Cardiac Arrhythmia Institute at St. David’s Medical Center to launch first-in-human studies using its Pure EP system. The Santa Monica, Calif.-based company’s Pure EP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals […]
Abbott launches FlexAbility cath ventricular tachycardia ablation trial
Abbott (NYSE:ABT) said yesterday that it launched a study aiming to evaluate ablation treatments for patients with ventricular tachycardia, touting it as the first such trial of its kind. In the trial, dubbed the Less-VT study, investigators will explore the safety and effectiveness of ablation with the Chicago-area medtech giant’s FlexAbility ablation catheter in treating monomorphic […]
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival […]
HeartFlow wins Japanese reimbursement for FFRct analysis
HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis. The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1. […]
Medtronic backs infant-sized miniature pacer
Medtronic (NYSE:MDT) is collaborating with researchers at the Children’s National Health System to develop a miniature pacemaker intended for use with infants. The prototype version of the device was presented at the American Heart Association’s 2018 Scientific Sessions by Dr. Rohan Kumthekar of the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of the Children’s National […]
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