Edwards Lifesciences (NYSE:EW) shares are recovering a bit today — a day after the stock took a nearly 5% slide after a Jefferies report suggested a potential step down in TAVR sales in December. The Jefferies model showed a sharp step down in December growth (–2% to +3%) from October and November (+27–28%). The result was […]
Teleflex wins FDA clearance for Wattson temporary pacing guidewire
Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). The Wattson guidewire is designed to simplify and shorten procedures by eliminating the need for the routine use of central venous access and transvenous temporary pacing […]
JenaValve TAVR wins FDA breakthrough device designation
JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols. “We are […]
Neovasc closes $10m direct offering
Neovasc (NSDQ:NVCN) announced that has it closed its previously announced registered direct offering for aggregate gross proceeds reaching approximately $10 million. The Vancouver, Canada-based company sold nearly 1.2 million Series A units at $4.1351 per unit and more than 1.2 million Series B units at $4.135 per unit. Each Series A unit includes one common share […]
Report: FDA has nonpublic list of TAVR-related deaths
The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News. Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved […]
CryoLife to begin investigational trial on using aortic valve without warfarin
CryoLife Inc. (NYSE:CRY) announced that it had its investigational new drug application accepted by the FDA for a clinical trial to observe whether the On-X mechanical aortic valve can be maintained on apixaban instead of warfarin. The On-X aortic valve is the first mechanical aortic heart valve to win FDA and CE Mark approval for labeling […]
Medtronic faces patent lawsuit over CoreValve tech
A decade-old company called Colibri Heart Valve is claiming in a lawsuit that Medtronic’s CoreValve line of TAVR devices are infringing on two of its patents. Founded in 2010, Broomfield, Colo.–based Colibri boasts that its TAVI system is the only one using dry tissue technology to allow for a pre-mounted, pre-crimped, and pre-loaded heart valve, […]
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 […]
Edwards IDs issue with Cardioband injuries
Edwards Lifesciences (NYSE:EW) has notified providers of a higher-than-expected rate of injuries during deployment of its Cardioband mitral/tricuspid valve reconstruction system (TMVR). Approximately 5.7% of patients treated with Cardioband suffered coronary artery injuries, most “as a result of direct interaction between the anchors of the Cardioband device and coronary arteries running adjacent to the valve […]
LivaNova pulls the plug on transcatheter mitral valve repair device
LivaNova (NSDQ:LIVN) said today that it is ending its Caisson Interventional transcatheter mitral valve replacement (TMVR) program and plans to restructure its heart valve business to improve profitability. The company’s heart valve business represented nearly $130 million in revenue during fiscal 2018 and saw its revenue numbers decline over the last five years, both with biological […]
Edwards’ Sapien 3 TAVI wins expanded approval in Europe
Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system. The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win […]
- 1
- 2
- 3
- …
- 62
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube