Mounting Use of'Primary' TAVR in Shock from Aortic Stenosis Mounting Use of'Primary' TAVR in Shock from Aortic Stenosis
' Can we claim the use of TAVR as the first-line therapy in any patient admitted with cardiogenic shock and aortic stenosis, ' observers asked. The observational study ' s results are ' encouraging. 'Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - June 4, 2020 Category: Cardiology Tags: Cardiology News Source Type: news
Edwards Lifesciences Drops 2020 Revenue Guidance Due to COVID-19
While Edwards Lifesciences reported first-quarter sales growth of 14%, the structural heart company saw a steep drop in procedure volume in the last few weeks of the quarter due to COVID-19.
"As you might expect, procedure volumes in March varied greatly by geography, even by hospital, as patients and providers turned their focus to the pandemic," CEO Mike Mussallem said during the company's first-quarter earnings call, according to a SeekingAlpha transcript.
Mussallem said the company expects the impact of COVID-19 on its transcatheter aortic valve replacement (TAVR) sales to be most severe in the second quarter, followed...
Source: MDDI - April 25, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
PCSK9 Inhibitors Unexpectedly Link With Lower VTE, Aortic Stenosis PCSK9 Inhibitors Unexpectedly Link With Lower VTE, Aortic Stenosis
Post hoc analyses of recent, large clinical-outcomes studies of PCSK9 inhibitors show that these drugs can substantially reduce the incidence or severity of venous thromboembolism and aortic stenosis.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 21, 2020 Category: Cardiology Tags: Cardiology News Source Type: news
Catheter-Based Solution Being Developed to Treat Heart Valve Calcification
Pi-Cardia Ltd. has raised $27 million to develop a catheter-based solution to treat heart valve calcification. The Rehovot, Israel-based company said the financing was led by Sonfinnova Partners and joined by Professor Jacques Séguin, Chairman of the company, with further participation from existing investors.
The financing follows the successful completion of the company’s First-In-Human studies of the Leaflex Catheter.
Pi-Cardia said its technology performs mechanical scoring of valve calcification, restoring leafelts’ mobility and improving valve hemodynamics. The company...
Source: MDDI - April 20, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Business Cardiovascular Source Type: news
Goals of Care in Patients With Severe Aortic Stenosis Goals of Care in Patients With Severe Aortic Stenosis
The number of adults with severe valvular aortic stenosis undergoing SAVR or TAVI has increased dramatically, but questions still remain about long-term outcomes and preferred modality.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 6, 2020 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
Persistent Mitral Regurgitation After TAVR Bodes Ill in Some Persistent Mitral Regurgitation After TAVR Bodes Ill in Some
Patients with low-flow, low-gradient aortic stenosis (LFLG-AS) who don ' t show improvement in mitral regurgitation following transcatheter aortic-valve replacement (TAVR) face an increased risk of mortality, according to a substudy of a multicenter registry.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - February 26, 2020 Category: Radiology Tags: Cardiology News Source Type: news
Five-Year Outcomes Comparable for TAVR, Surgical AVR
TUESDAY, Feb. 4, 2020 -- There is no significant difference in the incidence of death or disabling stroke at five years among patients with aortic stenosis at intermediate surgical risk who undergo transcatheter aortic valve replacement (TAVR) or... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 4, 2020 Category: Pharmaceuticals Source Type: news
RECOVERY: Early Surgery Best in Severe Asymptomatic AS? RECOVERY: Early Surgery Best in Severe Asymptomatic AS?
In asymptomatic patients with very severe aortic stenosis, early aortic valve replacement surgery was associated with lower mortality than a more conservative course.Medscape Medical News (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - November 19, 2019 Category: Intensive Care Tags: Cardiology News Source Type: news
Mandrola Previews 2019 AHA and the ISCHEMIA Trial Mandrola Previews 2019 AHA and the ISCHEMIA Trial
All eyes will be on ISCHEMIA in Philadelphia, but a study on asymptomatic aortic stenosis as well as trials in heart failure and cardiogenic shock also piqued Dr John Mandrola ' s interest.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 12, 2019 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news
Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe
Superior TAVI Valve Indicated for All Patients Diagnosed with Aortic Stenosis
IRVINE, Calif., Nov. 6, 2019 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for st... Devices, Interventional, Cardiology, Regulatory Edwards Lifesciences, SAPIEN 3, transcatheter, heart valve, aortic valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 6, 2019 Category: Pharmaceuticals Source Type: news
TAVR-Surgery Parity at 5 Years, Good Echo Result Key: PARTNER 2A TAVR-Surgery Parity at 5 Years, Good Echo Result Key: PARTNER 2A
Late outcomes were similar to 2-year results; worse-than-mild paravalvular leaks after either procedure meant a much worse prognosis in these intermediate-risk patients with severe aortic stenosis.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - October 3, 2019 Category: Cardiology Tags: Cardiology News Source Type: news
Medtronic Wins Nod for TAVR System Ahead of TCT 2019
Medtronic has won a nod from FDA for the Evolut PRO+ TAVR System – a next-generation transcatheter aortic valve replacement system. The agency’s approval of the device comes just a few days before – TCT 2019.
Plans call for the Dublin-based company to launch the product, which builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23, 26- and 29-mm valves can treat vessels down to 5.0 mm).
Evolut PRO+ features four-valve sizes â...
Source: MDDI - September 24, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
New Expanded Indication Could Change the TAVR Narrative
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves.
FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
How 2019 Will Define TAVR for Years to Come
There have been some pretty significant developments in the transcatheter aortic valve replacement market over the past few months. It’s safe to say it’s not going to be business as usual for TAVR in the coming years.
One of the biggest developments in the market was FDA’s approval of Boston Scientific’s Lotus Edge valve in April. The approval did not come as a shock as the Marlborough, MA-based company communicated in August of 2018 that the nod from FDA would come near the middle of 2019.
The approval was truly a game-changer because it meant there w...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
TAVI with SAPIEN 3 cost effective vs surgery for aortic stenosis
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - July 31, 2019 Category: Drugs & Pharmacology Source Type: news
