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

Cypher Impresses FDA Panel; Approval Recommended With More Drug Data

This article was originally published in The Gray Sheet

Executive Summary

The pharmacokinetic study specified by FDA's Circulatory System Devices Panel as a condition of approval for Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent could become a standard requirement for future drug/device combination trials

You may also be interested in...



Taxus Breezes Through Panel On Cypher Drag, Possibly Raising Data Bar

The FDA Circulatory System Devices Panel endorsed Boston Scientific's proposed ARRIVE 2,000-patient, five-year Taxus postmarket study with no additional conditions beyond proposals made by the company

Taxus Breezes Through Panel On Cypher Drag, Possibly Raising Data Bar

The FDA Circulatory System Devices Panel endorsed Boston Scientific's proposed ARRIVE 2,000-patient, five-year Taxus postmarket study with no additional conditions beyond proposals made by the company

Guidant ICD, Stent Tactics Assuage Wall Street; Q1 Index Inches Up

Guidant allayed investor uncertainty over its future business strategy by winning a favorable MCAC reimbursement recommendation and executing a string of stent technology acquisitions, propelling the stock ahead 17.3% for the first quarter

Related Content

UsernamePublicRestriction

Register

LL1133148

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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