Guidant
This article was originally published in The Gray Sheet
Executive Summary
Firm launches 360-patient, 40-center LIMIT trial to evaluate its Galileo intravascular radiation system in treatment of long coronary lesions (up to 47 mm) in up to two coronary arteries. Data will supplement the recently completed 332-patient, 27-center INHIBIT trial, which will form the basis of the firm's PMA submission for the Galileo (1"The Gray Sheet" Nov. 20, 2000, p. 6). Competitor Novoste expects to submit a PMA supplement shortly for an expanded indication for its Beta-Cath radiation system to treat lesions up to 40 mm. Novoste also expects to complete its 1,500-patient Beta-Cath System trial evaluating patients with de novo lesions in time for the March 18-21, 2001 American College of Cardiology meeting in Orlando. Both Guidant and Novoste also intend to submit PMA supplements for the de novo lesion indication next year
You may also be interested in...
Galileo PMA Submission Expected By Year-End; Early Review Possible
Guidant plans to file a premarket approval application with FDA by the end of the fourth quarter for its Galileo beta-emitting intravascular brachytherapy system.
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.