Thoratec VAD
This article was originally published in The Gray Sheet
Executive Summary
Ventricular assist device PMA supplement submission to FDA is anticipated by year-end to support a therapeutic recovery indication to reverse late-stage heart failure in certain patients as a viable alternative to transplantation. The device currently is approved for use as a bridge to cardiac transplantation and postcardiotomy recovery of the natural heart. Overall sales of the system increased nearly 40% in the first quarter ended April 1, as the company added ten new treatment centers (five in the U.S. and five internationally) to end the quarter with 140 centers. Corporate sales for the three months increased 41.5% to $7.6 mil., compared to $5.4 mil. in the same period one year ago. Net income of $649,000 compares to a loss of $336,000 in the first quarter of 1999
You may also be interested in...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.