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)
You may also be interested in...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.