Distal protection device submission
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash projects a July 510(k) submission for its TriActiv saphenous vein graft surgery distal protection device. The firm expects clearance this year, but no longer anticipates launching the system by the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. in September, as Kensey Nash previously stated in January. Former estimates were based on the assumption that a 510(k) based on the 894-patient PRIDE trial would be filed in April (1"The Gray Sheet" Jan. 26, 2004, p. 5)...
You may also be interested in...
TCT 2004 Highlights Peripheral Stenting, But DES Remains Hot Topic
Peripheral vascular disease devices will feature prominently at the Transcatheter Cardiovascular Therapeutics 2004 conference in Washington, D.C. Sept. 27-Oct. 1
Kensey Nash Extracts Biomaterials Growth To Curb Reliance On Angio-Seal
Kensey Nash likely will pursue an acquisition strategy and an expanded client base to leverage its biomaterial patents and manufacturing capability
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.