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, FDA Discuss Laser Indication Approval After Panel Says No

This article was originally published in The Gray Sheet

Executive Summary

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

You may also be interested in...



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

Spectranetics CVX-300 Panel Review Hindered By Historical Control Arm

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

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

UsernamePublicRestriction

Register

MT019379

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