Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Datascope VasoSeal data comparison to Prostar study invalid, Perclose maintains.

This article was originally published in The Gray Sheet

Executive Summary

PERCLOSE PROSTAR DATA COMPARISON TO DATASCOPE VASOSEAL STUDY INVALID, Perclose maintains in a Sept. 24 response to Datascope's petition for review of FDA's approval of Prostar's premarket approval application. Prostar study time-to-ambulation results for patients in the control group were prolonged by factors not shown to be present in the VasoSeal study, Perclose says in defending FDA approval of its vascular hemostasis device. "These differences -- and other unknowns -- underscore the fundamental invalidity of trying to compare the results across these studies," the company states.

You may also be interested in...



Cosmetic And Personal Care Trademark Review 24 November, 2020

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

CBD Health Benefits More Attractive To Women? FDA Prioritizes Research Into Utero Effects

Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA  neuroscientist Andrew Shen.

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

UsernamePublicRestriction

Register

OM001644

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel