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

PLC Systems

This article was originally published in The Gray Sheet

Executive Summary

Submits investigational device exemption on Nov. 7 for multi- center randomized clinical study of its Heart Laser for transmyocardial revascularization (TMR). The 400-patient trial would compare TMR to "second coronary artery bypass surgery" on the basis of exercise tolerance, myocardial perfusion and angina class, and other quality of life indicators. TMR involves creating small channels in the heart muscle to "provide oxygenated blood a direct conduit to the oxygen-starved tissue," the firm says. PLC hopes to submit a pre-market approval application in 1995 for the device based on studies published earlier this year with patients who were not candidates for bypass or angioplasty ("The Gray Sheet" July 11, p. 14)
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT003079

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