CardioFocus said today that it won CE Mark approval in the European Union for its HeartLight X3 endoscopic ablation system. The Marlborough, Mass.-based company said that the HeartLight X3 is its third-generation endoscopic ablation system intended to perform pulmonary vein isolation procedures using laser energy to block the abnormal electrical pathways that cause atrial fibrillation. The […]
Catheters
Boston Scientific touts Luminize catheter study
Boston Scientific (NYSE:BSX) this week touted results from a study of a single-shot ablation catheter for atrial fibrillation at a European cardiac rhythm conference. The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate […]
Study shows catheter ablation for Afib significantly boosts quality of life
Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study. The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and […]
Here’s how a new Abbott device is making a difference among neonatal infants
A recent CBS News report provided a real-life example of how Abbott’s Piccolo occluder is making a difference among neonatal infants with a congenital heart defect called patent ductus arteriosus (PDA). Irie and Judah Felkner are now healthy, growing 18-month-olds. But when Irie was born early at just 1 pound 13 ounces, she had a life-threatening PDA that […]
UPDATED: Cook Medical to pay $3m in damages in IVC bellwether
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, […]