Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s […]
HRS 2019 Roundup: Medtronic touts extravascular ICD pilot
The pilot study of an extravascular implantable cardiac defibrillator developed by Medtronic (NYSE:MDT), which is designed to deliver both defibrillation and anti-tachycardia pacing using leads placed outside the heart and venous system, showed strong safety and efficacy results. The safety outcome for the 26-patient study, presented last week at the annual meeting of the Heart […]
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, […]
Stereotaxis, J&J’s BioSense Webster extend deal for magnetic ablation catheters
Stereotaxis (NSDQ:STXS) said today it extended a long-term deal with Johnson & Johnson’s (NYSE:JNJ) Biosense Webster to supply it with magnetic ablation catheters. With the extended deal, St. Louis-based Stereotaxis said it will continue to supply Biosense Webster’s catheters, and will continue to receive a royalty for the sale of those catheters. The deal includes Biosense Webster’s Navistar […]
HRS 2018 Roundup: Researchers highlight the latest in cardiac ablation tech
There are lots of new opportunities in ablation, evidenced by the research touted at this year’s annual meeting of the Heart Rhythm Society in Boston. Scientists presented data from trials evaluating cardiac ablation via pulsed electric fields, intramural needle ablation and more. Editors at MassDevice.com asked leading cardiac electrophysiologist Dr. Vivek Reddy, will there someday be one […]
J&J’s Biosense Webster launches Carto Vizigo guiding sheath
Johnson & Johnson’s (NYSE:JNJ) Biosense Webster said yesterday it launched its Carto Vizigo bi-directional guiding sheath designed for use with the company’s Carto 3 system in the US. The Irvine, Calif.-based division said that the sheath is designed for use with the Carto 3 system during catheter ablation procedures to aid electrophysiologists in reducing fluoroscopy dependency and […]
J&J’s BioSense Webster launches Qdot Micro afib ablation cath trial
Johnson & Johnson’s (NYSE:JNJ) Biosense Webster said yesterday it launched a European trial of its Qdot Micro novel radiofrequency ablation catheter designed for treating paroxysmal atrial fibrillation. The Irvine, Calif.-based division said that the first patient in the trial has already been enrolled and treated by Aalst, Belgium’s OLV Hospital. “The concept of high power, short […]
J&J’s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system. The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation […]
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
FDA approves BioSense Webster’s Thermocool SmartTouch catheter
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today it won FDA premarket approval for its Thermocool SmartTouch SF catheter designed for ablation procedures. The Diamond Bar, Calif-based company touted the Thermocool SmartTouch as the only FDA-approved catheter ablation device designed to combine contact force technology and a porous tip. “The Thermocool SmartTouch SF Catheter represents a significant […]
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