The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures. Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers. Requirements in the 2012 decision […]
Edwards Lifesciences prices $600m senior notes offering
Edwards Lifesciences (NYSE:EW) this week priced a $600 million offering of senior notes due 2028. The Irvine, Calif.-based company inked an underwriting agreement to issue and sell 4.3% senior unsecured notes due 2028 through several underwriters, according to an SEC filing. Underwriters included in the offering are Merrill Lynch, Pierce, Fenner & Smith and J.P. Morgan […]
EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch
Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting. Delivery of the unit and its use in clinical cases are slated to resume during the third […]
MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm […]
8 companies commercializing transcatheter mitral valve replacements
Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used […]
Edwards inks $400m share repurchase deal
Edwards Lifesciences (NYSE:EW) said today it inked a deal to repurchase an aggregate of $400 million in its common shares. Under terms of the new share repurchasing deal, Edwards said it will receive approximately 2.5 million shares this month, with the final number of shares to be repurchased based on the volume weighted average share price […]
Edwards Lifesciences wins CE Mark for Cardioband transcath tricuspid valve system
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Cardioband transcatheter tricuspid valve reconstruction system, touting it as the first commercially cleared transcath therapy for treating tricuspid heart valve disease. The Cardioband tricuspid system is designed to be delivered through a transfemoral approach and is intended to reduce tricuspid regurgitation […]
V-Wave closes $70 million Series C
V-Wave said today it raised $70 million in a closed Series C round of financing, with funds slated to support the launch of a pivotal trial of its investigational interatrial shunt device designed for patients with advanced heart failure. The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, the Israel-based company said. […]
Edwards Lifesciences shares down on mixed-bag Q1 earnings release
Shares in Edwards Lifesciences (NYSE:EW) have fallen in after-hours trading today after the medical device maker posted first quarter earnings that beat earnings per share expectations, but missed sales consensus on Wall Street and showed shrinking profits. The Irvine, Calif.-based company posted profits of $206.6 million, or 96¢ per share, on sales of $894.8 million for […]
European Patent Office revokes Edwards Lifesciences patent in TAVR spat with Boston Scientific
Boston Scientific (NYSE:BSX) said today that the European Patent Office revoked a patent owned by Edwards Lifesciences (NYSE:EW) in the latest round of their ongoing spat over transcatheter aortic valve replacements. In March 2017 a German court issued a mixed decision in the international battle over transcatheter aortic valve replacement patents between the two companies, less than a week after a […]
This new technique could make TAVR more available
A novel technique could prevent coronary artery obstruction — a rare but often fatal complication related to transcatheter aortic valve replacement (TAVR), according to the National Institutes of Health researchers who created it. The researchers at NIH’s National, Heart, Lung, and Blood Institute are calling the procedure Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA). […]
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