Researchers published a paper in the Journal of the American Medical Association citing insufficient evidence regarding the superiority of TAVR devices. Currently, only three TAVR devices are commercially available in the U.S., belonging to Edwards Lifesciences (NYSE:EW), Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX), although several others are being used in clinical trials to evaluate safety and efficacy. Get the full story at our […]
Medtronic TTVR system wins breakthrough device designation
Medtronic (NYSE:MDT) announced that it received FDA approval for an early feasibility study of its Intrepid TTVR system. Fridley, Minn.-based Medtronic’s Intrepid TTVR (transcatheter tricuspid valve replacement) system is designed for patients with severe, symptomatic tricuspid regurgitation, treating a diseased, damaged or malfunctioning valve that allows blood to flow back into the upper right chamber of […]
FDA approves expanded use for Medtronic’s Evolut TAVR
Medtronic (NYSE:MDT) announced last week that it received FDA approval for revised commercial labeling on its Evolut TAVR platform. Fridley, Minn.-based Medtronic said in a news release that the revised labeling modified a precaution for the treatment of bicuspid severe aortic stenosis (AS) patients who are at low risk of mortality during surgical transcatheter aortic valve […]
TAVR sales growth was flat in July, Jefferies reports
Jefferies equity research reported that sales of transcatheter aortic valve replacement (TAVR) are better than the previous quarter with flat growth. Edwards Lifesciences (NYSE:EW) reported among its second-quarter results that TAVR sales had taken a -12% hit for the three months ended June 30, 2020. When the company reported its quarterly results, it noted that it […]
Neovasc raises $12.6M
Neovasc (NSDQ:NVCN) announced today that it agreed to sell shares of its common stock in a registered direct offering worth approximately $12.6 million. Vancouver, Canada-based Neovasc entered into definitive agreements with “certain healthcare-focused institutional investors,” according to a news release, for the offering that is expected to close on Aug. 12, according to a news release. […]
DTWeekly Podcast: Can Drawbridge, Edwards bring disruptive innovation to blood drawing, heart surgery industries?
In this week’s podcast, we talk with Holly Logue, general counsel at Drawbridge Health, about the OneDraw, an innovative new tool that might upend the collecting, storage and testing of blood. Logue, a panelist in the upcoming DeviceTalks Tuesdays sponsored by Finnegan, will explain how her past work on Capitol Hill is helping this Silicon […]
Edwards Lifesciences Q2 results are better than expected
Edwards Lifesciences (NYSE:EW) stock has jumped in after-hours trading after the company reported Street-beating Q2 results and boosted it earnings outlook. The Irvine, Calif.–based artificial heart valves and hemodynamic monitoring company reported a loss of –$122 million, or –20¢ per share, off $925 million in revenue during the quarter ended June 30. For the same quarter […]
FDA approves Edwards Lifesciences’ ready-to-implant aortic valved conduit
Edwards Lifesciences (NYSE:EW) announced today that FDA has approved its Konect Resilia aortic valved conduit (AVC). Edwards describes the Konect Resilia as the first ready-to-implant option for bio-Bentall procedures, a complex surgery that involves the replacement of a person’s aortic valve, aortic root and the ascending aorta. Surgeons find themselves having to perform nearly a third […]
BREAKING: Abbott, Edwards settle heart device patent spats
Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) said this afternoon that they have agreed to settle all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, and Edwards has made an one-time payment of $368 million to Abbott, according to an SEC filing. The agreement will result in the dismissal of all pending cases or appeals […]
Foldax closes $20m Series D
Heart valve designer and manufacturer Foldax announced today that it closed a Series D funding round with proceeds of $20 million. MemorialCare Innovation Fund led the round, which also included new investors Angel Physicians Fund and Sayah Bioventures. All existing investors, including BioStar Capital, Kairos Ventures and Caltech, participated as well. Salt Lake City-based Foldax […]
Medtronic wins CE mark for TAVI system in low-risk patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for […]
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