Updated to include a response from Cook Medical A federal jury in Indiana last week awarded $3 million in damages to a plaintiff in a bellwether case against Cook Medical over allegedly defective designs in the company’s Celect inferior vena cava filters. The plaintiff, Tonya Brand, sued Cook in 2014 alleging that the Celect IVC filter […]
J&J’s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation. The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the […]
FDA labels Edwards Lifesciences’ recall of Swan Ganz thermodilution caths as Class I
The FDA has labeled a select recall of Edwards Lifesciences‘ (NYSE:EW) Swan-Ganz Thermodilution catheters over issues with the lumen assembly as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function […]
Perfuze raises $3m seed round for Millipede stroke catheter
Perfuze said today that it raised more than $3 million for the Millipede catheter it’s developing to treat ischemic stroke. Although not quite in stealth mode, the Galway, Ireland-based firm is close-mouthed about its technology. CEO Wayne Allen and CTO Liam Mullins (who co-founded Embo Medical before its in 2015, $YY acquisition by C.R. Bard in 2015) founded […]
Medtronic to acquire cardiac ablation tech dev Epix Therapeutics
Medtronic (NYSE:MDT) said yesterday that it inked a deal to acquire cardiac ablation tech developer Epix Therapeutics, formerly known as Advanced Cardiac Therapeutics, for an undisclosed amount. Santa Clara, Calif.-based Epix’s flagship device is the DiamondTemp catheter-based radiofrequency cardiac ablation system, which won CE Mark approval in the European Union in 2017. The company is engaged […]
FDA clears Abbott’s TactiCath Sensor Enabled AF contact force ablation cath
Abbott (NYSE:ABT) said today that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation. The newly cleared TactiCath SE is intended to provide precise images of the heart overlaid with real-time electrical activity information, the Chicago-area medtech company said. The catheter also features an ergonomic […]
Cardiovascular Systems touts first patients treated with Teleport microcatheter
Cardiovascular Systems (NSDQ:CSII) touted today that the first patients in the U.S. were treated with the OrbusNeich Teleport microcatheter. The device, which recently won 510(k) clearance with the FDA, enables safe guidewire exchange during cardiovascular procedures. The Teleport product features a robust tip to provide access to challenging lesions, according to Cardiovascular Systems. Dr. Annapoorna Kini, […]
Venus Medtech completes Keystone Heart merger
Chinese transcatheter heart valve maker Venus Medtech said today that it closed its merger with Keystone Heart. Privately-held Keystone Heart sells TriGuard embolic protection devices that are designed to protect the brain during transcatheter aortic valve replacement and other cardiac procedures. Hoping for FDA approval in the third quarter of 2019, Keystone Heart is enrolling patients […]
Study: Catheter ablation better for AFib, heart failure than drugs
A meta-analysis of randomized controlled trials has found that catheter ablation was superior to conventional drug therapy alone for patients with atrial fibrillation (AFib) and heart failure. AFib may lead to thromboembolic stroke, systemic embolism, and decompensated heart failure. Although catheter ablation is an established therapeutic strategy for AFib, guidelines recommend caution in certain patients, […]
Merit Medical puts $60m on the table for Vascular Insights
Merit Medical (NSDQ:MMSI) said yesterday that it put $60 million on the table to acquire Vascular Insights and its ClariVein line of catheters, including a $20 million milestone pegged to sales targets. Quincy, Mass.-based Vascular Insights makes the ClariVeinIC and ClariVeinOC infusion and occlusion catheters for treating superficial venous disease. “We have had our eye on […]
BioCardia submits bid for FDA clearance of Avance transseptal introducer
BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
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