Avinger Inc. announced that the company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next-generation Pantheris Lumivascular atherectomy system. Avinger calls it the first-ever image-guided atherectomy device for the treatment of peripheral artery disease. Lumivascular is the only technology, according to the company, that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. Peripheral artery disease is projected to affect more than 21 million people in the United States alone by 2020.
At the 2018 EuroPCR Annual Meeting in Paris, Medtronic announced first-ever-data from the SPYRAL HTN-ON MED Study. Initial study results found statistically significant and clinically important blood pressure reductions in hypertensive patients prescribed anti-hypertension medications treated with the Symplicity Spyral renal denervation (RDN) system with no major adverse safety events out to six months.
Medtronic announced on May 23, 2018 that it will discontinue marketing for its SEEQ Mobile Cardiac Telemetry (MCT) System to concentrate support on its Reveal LINQ Insertable Cardiac Monitor (ICM) System.
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
Guerbet LLC USA announced the upcoming launch of SeQure and DraKon, two novel microcatheters for tumor and vascular aneurysm embolization procedures. The company introduced the microcatheters at the Global Embolization Symposium and Technologies (GEST) 2018 U.S., May 17-20 in Miami.
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the device’s outflow graft assembly. The company said the malfunction may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
Medtronic plc announced study results showing its AdaptivCRT algorithm is associated with improved patient survival. The data were presented at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions, May 9-12 in Boston.
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018 Heart Rhythm Society (HRS) conference, May 9-12 in Boston. The OmniView light-guided ablation catheter is the only technology, according to the company, that can see into tissue during cardiac ablation and assess catheter-tissue contact and lesion progression in real time. This offers electrophysiologists a simple and more definitive end point for lesion quality, increasing the potential for complete and more effective cardiac ablation.
Pie Medical Imaging announced that clinical data on its CAAS vFFR (Cardiovascular Angiographic Analysis Systems for vessel Fractional Flow Reserve) software will be presented during EuroPCR 2018, May 22-25 in Paris, France. This software, which has received U.S. Food and Drug Administration (FDA) 510(k) clearance, can calculate the pressure drop and vFFR value in the coronary artery non-invasively, which means there is no need for a pressure wire and hyperemic agent.
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in ...
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
May 21, 2018 — The available electrophysiology catheter ablation technologies are not designed for use in the ...
Electrophysiology is one of the most rapidly-growing areas of healthcare. That may be why it’s the focus of so many ...
Medtronic and the U.S. Food and Drug Administration (FDA) announced a Class I Urgent Medical Device Recall of the MindFrame Capture LP revascularization device on account of a risk of the delivery wire breaking or separating during use.
Change Healthcare Cardiology Hemodynamics is an integrated hemodynamic monitoring system for monitoring vital signs and ...
May 21, 2018 — Cardiology medical device reprocessing company Innovative Health recently received U.S. Food and Drug ...
May 21, 2018 — A recent study published in Heart and Vessels has found that the use of the Baylis Medical NRG ...
Data on the effectiveness of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (non-LBBB) is limited and when available has been shown to be suboptimal compared to LBBB patients. A new study presented at the 2018 Heart Rhythm Society (HRS) Scientific Sessions, May 9-12 in Boston, compared the effects of targeting the region of increased electrical delay (QLV approach) for left ventricular (LV) lead location to a standard of care (SOC) anatomical implant approach in non-LBBB patients. The comparison was assessed on the Clinical Composite Score (CCS) after 12 months of follow-up.