BioVentrix announced today that it received an extension of its CE Mark for the Revivent TC transcatheter ventricular enhancement system for heart failure. The extension of the initial CE Mark approval BioVentrix won in 2016 allows the device to be marketed throughout European Union member nations until May 2024, according to a news release. BioVentrix’s […]
BREAKING: Medtronic wins FDA approval for Micra AV
Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from leadless pacemaker technology. The medical device giant plans to start offering the Micra AV in a limited number of implanting centers in the coming weeks, with a full launch expected in the spring. FDA […]
Abbott wins MitraClip patent spat with Edwards — for now
The U.S. Patent Trial and Review Board (PTAB) this week shot down an attempt by Edwards Lifesciences (NYSE:EW) to invalidate the patents that Abbott (NYSE:ABT) holds on its MitraClip transcatheter mitral valve repair (TMVR) device. In a ruling published Thursday, the PTAB said Edwards failed to show that it would prevail in with at least one […]
FDA-approved clinical trial to study expanded use of Abbott’s MitraClip
Abbott (NYSE:ABT) said today that U.S. FDA has approved a clinical trial to study the effectiveness of its MitraClip transcatheter mitral valve repair device in people eligible for open-heart surgery. The MitraClip has been available in the U.S. since 2013 and Europe since 2008 — but is only indicated as an option for people who don’t have […]
Abbott LVAD wins FDA approval for implantation without open heart surgery
Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach than open-heart surgery. The approval comes about a year and a half after Medtronic (NYSE:MDT) won a similar approval for the competing HeartWare HVAD pump. Lateral thoracotomy involves a surgeon making an incision between a person’s […]
Edwards projects $5 billion in sales for 2020
Wall Street expressed brief unhappiness with projections made at today’s Edwards Lifesciences (NYSE:EW) annual investor conference in New York, but shares had recovered partially by the close of trading. The Irvine, Calif.-based heart valve replacement pioneer projected adjusted EPS of $6.05 to $6.30 on global sales of $4.5 billion to $5 billion for 2020. Edwards […]
New study touts positive long-term results for Boston Sci’s Watchman
A long-term followup study on Boston Scientific’s (NYSE:BSX) Watchman heart implant shows low risk of hemorrhagic stroke and a high percentage of patients who discontinued anticoagulation drugs at one year. Published this week in the Journal of the American College of Cardiology, the new registry data represent the largest number and longest follow-up of patients […]
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]
Report: Sanctions against Boston Scientific overturned in court
A Minneapolis federal judge has overturned sanctions imposed last month on Boston Scientific in a whistleblower lawsuit lodged over two of its cardiac rhythm management devices. U.S. District Court Judge Joan Ericksen on Monday vacated the sanctions ordered Oct. 16 by the late Judge Steven Rau, according to a report by Law360. Rau had lambasted the […]
BioVentrix wins breakthrough nod for transcatheter-based structural heart device
BioVentrix announced today that it won FDA breakthrough device designation for its Revivent TC transcatheter ventricular enhancement system for heart failure. The Revivent TC system is used in less invasive ventricular enhancement (LIVE) procedures intended to exclude scar tissue on the left ventricle that resulted from a heart attack so that the healthy portion of […]
FDA aims to publicly report information on Watchman-related deaths
This article has been updated with comments from the American College of Cardiology. The FDA said Thursday that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives that information from the company. The agency said it has asked the sponsor of a Watchman […]
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