Medical science continues to define the relative risks of progressively smaller patient subsets across the disease spectrum, but this is particularly true of late in connection with aortic stenosis (AS).
Edwards Lifesciences Corp., of Irvine, Calif., reported positive quarterly results Jan. 30, and it was particularly bolstered by strength with transcatheter aortic valve replacement (TAVR). CEO Mike Mussallem called out the fourth quarter underlying sales growth of 19%, giving much credit to TAVR.
Edwards Lifesciences Corp. added more than $20 billion so far this year to its market cap to exceed a $50 billion valuation. Executives worked to convince Wall Street that 2020 and beyond are lining up to be additional banner years for the cardiovascular med-tech giant at the company’s annual investor meeting. While the newly introduced guidance for next year from Edwards was largely in line or a bit better than analysts had anticipated, its share price remained relatively flat on the event.
Patients undergoing transcatheter aortic valve implant may need a pacemaker after the TAVR device, but a new study suggests that right bundle branch block may predict the need for pacing. The data may have implications for device selection as some devices are seen as less likely to trigger the need for a pacemaker, a development that may move the needle in the robust but increasingly competitive market for TAVR.
Edwards Lifesciences Corp. has been unstoppable so far this year, driven by the rapidly expanding adoption of transcatheter heart valve therapy. It beat expectations in its third-quarter earnings report, drawing praise and even higher expectations from Wall Street analysts. The Irvine, Calif.-based company recently received an expanded FDA indication for its Sapien 3 and Sapien 3 Ultra TAVR systems to treat surgical low-risk patients with severe aortic stenosis. (See BioWorld MedTech, Aug. 19, 2019.)
A recent medical journal article says the terminology used by physicians to denote a fatality in the FDA adverse event reporting system has led to underreporting of fatalities associated with two prominent cardiology devices, a predicament the authors say skews the public understanding of these devices' safety profiles.
SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
