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

Spectranetics CVX-300 Panel Review Hindered By Historical Control Arm

This article was originally published in The Gray Sheet

Executive Summary

FDA should have discouraged Spectranetics from conducting a non-randomized trial for critical limb ischemia (CLI), Circulatory System Devices Panel members asserted Oct. 2

You may also be interested in...



Spectranetics, FDA Discuss Laser Indication Approval After Panel Says No

Spectranetics plans to use a 50-patient Belgium study to shore up support for an indication covering its CVX-300 excimer laser catheter system for critical limb ischemia patients with lesions not crossable with a guidewire

Spectranetics, FDA Discuss Laser Indication Approval After Panel Says No

Spectranetics plans to use a 50-patient Belgium study to shore up support for an indication covering its CVX-300 excimer laser catheter system for critical limb ischemia patients with lesions not crossable with a guidewire

FDA Passes On Critical Limb Ischemia Laser; Spectranetics Ponders Options

Spectranetics hopes FDA will accept a retrospective analysis of bypass surgery data as a control arm to support a critical limb ischemia indication for its CVX-300 excimer laser catheter system in lieu of further clinical studies

UsernamePublicRestriction

Register

LL010986

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